Drug Recall List
Class
Class 1 Recall : Reasonable probability that using the drug will cause serious adverse health consequences or death.
Class 2 Recall: Using the drug may cause temporary or medically reversible adverse health consequences, the probability of serious adverse health consequences is remote.
Class 3 Recall: Using the drug is not likely to cause adverse health consequences.
Drug Recall List Last Updated: January 2022
Drug
Recall Details
Contact
Date
Drug Recall Class*
Lexette (halobetasol propionate)
CGMP Deviation
If you have questions
January
Class
05186260450
about this recall, Mayne Pharma Inc, 844 825 8500
2022
II
Clobazam 07778905804
Failed Stability Specifications
If you have questions about this recall,
January 2022
Class II
Ingenus Pharmaceuticals LLC, 877-530-1633.
Clobetasol Propionate
CGMP Deviations
If you have questions
January
Class
05074230450 05074230401
about this recall, Ingenus Pharmaceuticals LLC, 1-407-354-5740
2022
II
Brinzolamide
Defective Container
If you have questions
January
Class
00591212779 00591212712
about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
2022
II
8.4% Sodium Bicarbonate
Lack of Assurance of Sterility
If you have questions
January
Class
05175450011
about this recall, Exela
2022
II
Pharma Sciences LLC, 1-
888-451-4321
Metformin 70518292000
CGMP Deviations
If you have questions about this recall,
January 2022
Class II
RemedyRepack Inc., 1- 866-845-3791
Norepinephrine Bitartrate 00703115303
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals
January 2022
Class II
USA, 1-800-545-8800
MethylPREDNISolone Acetate 01671409001
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals
January 2022
Class II
USA, 1-800-545-8800
Carbamazepine 01366826801
Failed Dissolution Specifications
If you have questions about this recall,
January 2022
Class II
Torrent Pharma Inc, 1- 888-280-2040.
Clobetasol Propionate 05167212593
Microbial Contamination of Non-Sterile Products
If you have questions about this recall, Taro Pharmaceuticals U.S.A., Inc.,1-800-544-1449 ext
January 2022
Class I
6066.
Pregabalin 04733568788
Failed Tablet/Capsule Specifications
If you have questions about this recall, SUN PHARMACEUTICAL INDUSTRIES INC, 1-800- 818-4555
January 2022
Class II
Lidocaine Hydrochloride 06373999764
Superpotent Drug
If you have questions about this recall, Teligent Pharma, 1-856-697-1441
January 2022
Class II
Lidocaine Hydrochloride 06373999764
Superpotent Drug
If you have questions about this recall, Teligent Pharma, 1-856-697-1441
January 2022
Class I
Betamethasone Dipropionate 05256502329
Failed Stability Specifications
If you have questions about this recall, Teligent Pharma, 1-856-697-1441
January 2022
Class II
Penicillin V Potassium 00093412573 00093412574
Subpotent
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
December 2021
Class II
Fexofenadine Hydrochloride 00904697940
Failed Impurities/Degradation Specifications
If you have questions about this recall, The Harvard Drug Group, 1- 800-875-0123.
December 2021
Class II
Clindamycin and Benzoyl Peroxide Gel 00781726368
Superpotent Drug
If you have questions about this recall, TOLMAR, Inc., 1-970-212- 4500
December 2021
Class II
Lidocaine Hydrochloride 05256500950
Superpotent Drug
If you have questions about this recall, Teligent Pharma, 1-856-697-1441
December 2021
Class I
Lidocaine Hydrochloride 06373999764 05256500950
CGMP Deviations
If you have questions about this recall, Teligent Pharma, 1-856-697-1441
December 2021
Class II
Cefixime 70518274902
Failed Impurities/Degradation Specifications
If you have questions about this recall, RemedyRepack Inc., 1- 866-845-3791
December 2021
Class II
Diclofenac Sodium 68788770701
Defective container
If you have questions about this recall, Preferred Pharmaceuticals, Inc., 1- 714-777-3729
December 2021
Class II
Hydrocodone Bitartrate and Acetaminophen 03172299701
Product Mix-up
If you have questions about this recall, Ascent Pharmaceuticals, Inc., 1-631-851-0550
December 2021
Class II
Cefixime 06787758450
Failed impurities/degradation specifications
If you have questions about this recall, Ascend Laboratories, LLC, 1-201-476-1977
December 2021
Class II
Ascorbic Acid
Lack of Assurance of Sterility
If you have questions about this recall, ASP Cares, 1-210-615-7400
December 2021
Class II
Diclofenac Sodium 05266500205 05266502505
Defective Container
If you have questions about this recall, Teligent Pharma, 1-856-697-1441
December 2021
Class II
Flocinolone Acetonide 06516270486 06516270386
Subpotent Drug
If you have questions about this recall, Amneal Pharmaceuticals., 1-833- 582-0812.
December 2021
Class II
Cefixime 06787758450
Failed Impurities/Degradation Specifications
If you have questions about this recall, Ascend Laboratories LLC, 1-201-476-1977
November 2021
Class II
Tadalafil 01671407501 01671407701
Incorrect Product Formulation
If you have questions about this recall, SUN PHARMACEUTICAL INDUSTRIES INC, 1-800- 818-4555
November 2021
Class II
Ezetimibe and Simvastatin 05140719305
Failed Excipient Specification
If you have questions about this recall, Dr. Reddy’s Laboratories, Inc., 1-888-375-3784
November 2021
Class II
Ezetimibe and Simvastatin 05140719290 05140719205
cGMP Deviations
If you have questions about this recall, Dr. Reddy’s Laboratories, Inc., 1-888-375-3784
November 2021
Class II
Methocarbamol 07133517952 07133517954 07133517957
Labeling: Label Error on Declared Strength
If you have questions about this recall, 1-877- 885-0882.
November 2021
Class I
Irbesartan and Hydrochlorothiazide 06818041306 06818041309 06818041406 06818041409
CGMP Deviations
If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3
November 2021
Class II
Irbesartan 06818041006 06818041009 06818041106 06818041109 06818041206 06818041209
CGMP Deviations
If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3
November 2021
Class II
Ezetimibe and Simvastatin 04359874290 04359874210 04359874430 04359874490 04359874530 04359874590 04359874505 04359874330 04359874390 04359874305
Failed Excipient Specifications
If you have questions about this recall, Dr. Reddy’s Laboratories, Inc., 1-888-375-3784
November 2021
Class II
Rocuronium Bromide 66794022841
Labeling: Label Lacks Warning or Rx Legend
If you have questions about this recall, Piramal Critical Care, Inc. 1-800-414-1901
October 2021
Class II
Imipramine Pamoate
Out of specification result observed in a dissolution test
If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3
October 2021
Class II
Omeprazole Delayed-Release 07000002321
CGMP Deviations
If you have questions about this recall, Dr. Reddy’s Laboratories, Inc. 1-888-375-3784
October 2021
Class II
AirDuo Digihaler 232/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) 05931013606
Subpotent drug
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
October 2021
Class II
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) 05931012906
Subpotent drug
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
October 2021
Class II
AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) 05931011106
Subpotent drug
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
October 2021
Class II
AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) 05931053008
Subpotent drug
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
October 2021
Class II
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) 05931052008
Subpotent drug
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
October 2021
Class II
AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) 05931052008
Subpotent drug
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
October 2021
Class II
GlipiZIDE Extended-Release 06808429521 06808429511
Failed Dissolution Specifications: results were above specification.
If you have questions about this recall, American Health Packaging, 1-614-492-8177
October 2021
Class II
Glucagon Emergency Kit 00002803101
Subpotent Drug
If you have questions about this recall, Eli Lilly & Company, 1-800-545-5979
October 2021
Class I
Betaxolol Ophthalmic 01747870510 01747870511
Microbial Contamination of Sterile Products
If you have questions about this recall, Akorn, Inc., 1-855-526- 4827
October 2021
Class II
Artesunate 07360700101 07360700111 07360700101
Lack of Assurance of Sterility
If you have questions about this recall, AMIVAS (US), LLC, 1-855-526-4827
October 2021
Class II
07360700102 07360700110
Meclizine HCl Tablets, 25 mg 01657175201
Labeling: Incorrect Instructions
If you have questions about this recall, RISING PHARMACEUTICALS, 1-866-562-4597
October 2021
Class II
Firvanq (vancomycin hydrochloride for oral solution) 06562820605
Product Mix-up
If you have questions about this recall, Azurity Pharmaceuticals, Inc., 1-800-461-7449
October 2021
Class I
Morphine Sulfate 06332345201
Defective container
If you have questions about this recall, Fresenius Kabi USA, 1- 800-551-7176.
October 2021
Class II
Valproic Acid 06068726256 06068726242
CGMP Deviations
If you have questions about this recall, American Health Packaging, 1-800- 707-4621.
October 2021
Class II
Lyrica CR (pregabalin) 00071102901
Failed Dissolution Specifications
If you have questions about this recall, Pfizer Inc.,1-800-438-1985.
October 2021
Class II
Zonisamide 61919077530
CGMP deviations
If you have questions about this recall, Direct Rx, 1-678-619-5510
September 2021
Class II
Metoprolol Tartrate 06586206499
Presence of Foreign Substance
If you have questions about this recall, Aurobindo Pharma USA Inc., 1-866-850-2876
September 2021
Class II
Entacapone 00904682204
Failed Dissolution Specifications
If you have questions about this recall, The Harvard Drug Group, 1- 800-875-0123.
September 2021
Class II
Valproic Acid 06043262116
CGMP Deviations
If you have questions about this recall, Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115
September 2021
Class II
Promethazine With Codeine 06043260616
CGMP Deviations
If you have questions about this recall, Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115
September 2021
Class II
Promethazine Syrup 06043260816
CGMP Deviations
If you have questions about this recall, Morton Grove Pharmaceuticals, Inc., 1- 888-721-7115
September 2021
Class II
Arformoterol Tartrate 06846283365 06846283335
Lack of Assurance of Sterility
If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115
September 2021
Class II
Zonisamide 06846212901 06846213001 06846213005
CGMP Deviations
If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115
September 2021
Class II
Chlorzoxazone 06846272401 06846272501
CGMP Deviations
If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115
September 2021
Class II
Naproxen Sodium 06846217801 06846217901 06846217905
CGMP Deviations
If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115
September 2021
Class II
Fulvestrant 06846231732
Lack of Assurance of Sterility
If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115
September 2021
Class II
Carbamazepine 00904617261
Failed Dissolution Specifications
If you have questions about this recall, The Harvard Drug Group, 1- 800-875-0123.
September 2021
Class II
Betadine Solution Swabstick 06761815301 06761815303
Subpotent Drug
If you have questions about this recall, AVRIO HEALTH L.P, 1- 888-726-7535
September 2021
Class II
Chantix (varenicline) 00069047103 00069046856 00069046956 00069046903
CGMP Deviations
If you have questions about this recall, Pfizer Inc.,1-800-438-1985.
September 2021
Class II
Oxycodone Hydrochloride 04285800201
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
If you have questions about this recall, Akorn, Inc, Rhodes Pharmaceuticals, L.P., 1-401-262-9400, Prompt 2
September 2021
Class II
Betamethasone Dipropionate 06174848030
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
If you have questions about this recall, Akorn, Inc, 1-800-932-5676, Prompt 2
September 2021
Class II
Naproxen Sodium 06220776236
CGMP Deviations
If you have questions about this recall, Granules USA, Inc., 1877-770-3183
September 2021
II
Clopidogrel 03334206015
Presence of foreign matter
If you have questions about this recall, Macleods Pharma Usa Inc, 1-888-943-3210
September 2021
II
Cyclobenzaprine Hydrochloride 00591333001 07019901401 05723726601
CGMP Deviations
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
September 2021
II
FLUDARABINE PHOSPHATE FOR INJECTION 02420123701
Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing.
If you have questions about this recall, Custopharm, Inc., 1760- 683-0901
September 2021
II
Erythromycin Topical Solution 05256502759
Defective container: possibility for lack of seal integrity.
If you have questions about this recall, Teligent Pharma, 1-856-697-1441
September 2021
II
Atovaquone Oral Suspension 01070222321
Temperature abuse: the firm received customer complaints of unusual grittiness in the product.
If you have questions about this recall, KVK-Tech, Inc., 1-215- 579-1842
September 2020
II
Carvedilol 06838209505 70518182601
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
If you have questions about this recall, RemedyRepack Inc., 1- 866-845-3791
September 2021
II
Adenosine 01671418001
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
Leucovorin Calcium 00703514001 00703514591
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
Octreotide Acetate 00703331101 00703330101
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
Methylprednisolone Acetate 00703005101 00703006301
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800
August 2021
II
Alprostadil 00703150101
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800
August 2021
II
Metoclopramide 00703450201
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
Adenosine Injection 00703877601
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
Norepinephrine Bitartrate 00703115301
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
Epoprostenol Sodium 00703199501
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
Leucovorin Calcium 00703514501
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
Octreotide Acetate 00703333301
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800
August 2021
II
Vecuronium Bromide 00703291401
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800
August 2021
II
Idarubicin Hydrochloride 00703415611
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
Amikacin Sulfate 00703904001
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
Haloperidol Decanoate 00703713101 00703713301
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
Methylprednisolone Acetate 00703003101 00703004301 00703004501
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
DAUNOrubicin Hydrochloride 00703523313
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
August 2021
II
GaviLyteTM 04338606019
Failed Stability Specification; Out of specification for Osmolarity
If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3
August 2021
II
Combipatch 06896805148 06896805258
Failed Stability Specifications; out of specification for shear.
If you have questions about this recall, Noven Pharmaceuticals Inc, 1-305-253-5099
August 2021
II
Tizanidine HCl 05511118015
Failed Tablet/Capsule Specification: Some tablets are shaved
If you have questions about this recall, Dr. Reddy’s Laboratories, Inc., 1-888-375-3784
August 2021
II
Triamcinolone Acetonide 05256501480
Correct Labeled Product Mispack
If you have questions about this recall, Teligent Pharma, 1-856-697-1441
August 2021
II
Econazole Nitrate 05256501480
Correct Labeled Product Mispack
If you have questions about this recall, Teligent Pharma, 1-856-697-1441
August 2021
II
Ethosuximide 00121067016
Voluntary: Firm initiated
If you have questions about this recall, PAI Holdings, LLC. dba Pharmaceutical Associates Inc1-864-277- 7282 ext 0
August 2021
II
Cimetidine Hydrochloride 00121064908
Voluntary: Firm initiated
If you have questions about this recall, PAI Holdings, LLC. dba Pharmaceutical Associates Inc1-864-277- 7282 ext 0
August 2021
II
Nystatin Oral 00121086816 00121086802
Voluntary: Firm initiated
If you have questions about this recall, PAI Holdings, LLC. dba Pharmaceutical Associates Inc1-864-277- 7282 ext 0
August 2021
II
Venlafaxine 01671465701
Voluntary: Firm initiated
August 2021
II
Sulfamethoxazole and Trimethoprim 06586242005
Voluntary: Firm initiated
If you have questions about this recall, Aurobindo Pharma USA Inc., 1-866-850-2876
August 2021
II
Zyprexa Intramuscular, Olanzapine 00002759701
Voluntary: Firm initiated
If you have questions about this recall, Eli Lilly & Company. 1-317-276- 2000
August 2021
II
Chantix 00069046856 00069047103 00069046956
CGMP Deviations
If you have questions about this recall, Pfizer Inc.,1-800-438-1985.
August 2021
II
Estriol 04614430001
cGMP Deviations
If you have questions about this recall, API Solutions Inc., 1-855-878-1489
August 2021
II
NIFEdipine EXTENDED- RELEASE 00904708061 00904708006
Failed Dissolution Specification
If you have questions about this recall, Ingenus Pharmaceutical. 1-877- 748-1970
July 2021
II
Solifenacin Succinate 06909726102
CGMP Deviations
If you have questions about this recall, CIPLA, 1-866-604-3268.
July 2021
II
Xylocaine-MPF with Epinephrine 06332348737 06332348707
Low out of specification results for epinephrine assay
If you have questions about this recall, Genentech Inc, 1-888- 835-2555.
July 2021
II
Xolair (omalizumab) 05024221501
Failed Stability Specifications
If you have questions about this recall, Fresenius Kabi USA, 1- 800-551-7176.
July 2021
II
Buprenorphine and Naloxone Sublingual Film 04778135503
Subpotent drug
If you have questions about this recall, Alvogen, Inc. 1-866-770-3024
July 2021
II
Topotecan Injection 00703471471
Presence of Particulate Matter
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
July 2021
I
Metformin Hydrochloride Extended-Release 07257803601
CGMP Deviations
If you have questions about this recall, VIONA PHARMACEUTICALS INC 1-888-304-5022
June 2021
Class II
DermOtic Oil (fluocinolone acetonide oil) 68791-103-20
Presence of Foreign Substance
If you have questions about this recall, Hill Dermaceuticals, Inc.,1-407-323-1998
June 2021
Class II
Diflorasone Diacetate Ointment 05256506315 05256506330
Presence of Foreign Substance
If you have questions about this recall, Teligent Pharma, 1-856-697-1441
June 2021
Class II
BusPIRone Hydrochloride 06958409310
Presence of Foreign Tablets/Capsules
If you have questions about this recall, Oxford Pharmaceuticals, LLC, 1- 205-434-9649
June 2021
Class II
Micardis 0597004137
Subpotent Drug
If you have questions about this recall, Boehringer Ingelheim Pharmaceuticals, Inc., 1- 908-927-1400
June 2021
Class II
ChloraPrep With Tint 2% w/v chlorhexidine gluconate 005436540011
Microbial Contamination of Non- Sterile Product
If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800.
May 2021
Class I
ChloraPrep One-Step 2% w/v chlorhexidine gluconate 005436540001
Microbial Contamination of Non- Sterile Product
If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800.
May 2021
Class I
BD ChloraPrep Hi-Lite Orange 2 05436540033
Non-sterility
If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800.
May 2021
Class I
BD ChloraPrep Clear 05436540032
Non-sterility
If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800.
May 2021
Class I
Estradiol Transdermal System 06896834378
Defective Delivery System
If you have questions about this recall, Noven Pharmaceuticals Inc, 1-305-253-5099
April 2021
Class II
Minivelle 06896866758
Defective Delivery System
If you have questions about this recall, Noven Pharmaceuticals Inc, 1-305-253-5099
April 2021
Class II
Itraconazole 05974628230
Failed Dissolution Specifications
If you have questions about this recall, Jubilant Cadista Pharmaceuticals, Inc., 1- 410- 860-2836
April 2021
Class II
Riomet (metformin hydrochloride oral solution) 01063120602
Microbial Contamination of Non- Sterile Product
If you have questions about this recall, SUN PHARMACEUTICAL INDUSTRIES INC, 1-800- 818-4555
April 2021
Class II
Cefprozil 06818040201 06818040202 06818040203
Superpotent Drug
If you have questions about this recall, Lupin Pharmaceuticals Inc., 1-866-587-4617
April 2021
Class II
Guanfacine Extended-Release 06050539281 36050539281
Cross Contamination
If you have questions about this recall, Apotex Corp., 1 866.390-4411.
April 2021
Class II
Mometasone Furoate 00713070185 00713070153
CGMP Deviaitons
If you have questions about this recall, Cosette Pharmaceuticals, Inc., 1 866.390-4411.
April 2021
Class II
Neomycin Sulfate 03982203105
Failed Stability
If you have questions about this recall, X-Gen Pharmaceuticals Inc., 1-866-390-4411.
April 2021
Class II
Telmisartan 06233208730
Labeling: Label-mixup
If you have questions about this recall, Alembic Pharmaceuticals Limited, 1-908-393-9604
April 2021
Class I
Progesterone Capsules 04359835001
Failed Dissolution Specifications
If you have questions about this recall, Dr. Reddy’s Laboratories, Inc., 1-888-375-3784
March 2021
Class II
Metoclopramide Injection 0703450204
Chemical contamination
If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800
March 2021
Class II
Famotidine Tablets 06586286099
Presence of foreign tablets/capsules
If you have questions about this recall, Aurobindo Pharma USA Inc. 1-866-850-2876
March 2021
Class II
Phenylephrine HCl 02502131501
Lack of Assurance of Sterility
If you have questions about this recall, Sagent Pharmaceuticals Inc, 1- 866-625-1618
March 2021
Class II
Gabapentin 05038331107
Failed Impurities/Degradation Specifications
If you have questions about this recall, Akorn, Inc, 1-800-932-5676, Prompt 2
March 2021
Class II
Nortriptyline HCL 06191985330
Failed Impurities/Degradation Specifications
If you have questions about this recall, Direct Rx, 1-678-619-5510
March 2021
Class II
Spironolactone Tablets 63629106701
Labeling: Label Mix-Up
If you have questions about this recall, BRP Pharmaceuticals, 1- 877-885-0882
March 2021
Class II
Daytrana (methylphenidate transdermal system) 06896855523 06896855533 06896855543 06896855553
Defective Delivery System: Out of specification for mechanical peel
If you have questions about this recall, Noven Pharmaceuticals Inc, 1-305-253-5099
March 2021
Class II
Omeprazole Delayed-Release Capsules 05199164310
Failed Impurities/Degradation Specifications
If you have questions about this recall, Breckenridge Pharmaceutical, Inc, 1- 860-828-8140
March 2021
Class II
Omeprazole Delayed-Release Capsules 05140712910
Failed Impurities/Degradation Specifications
If you have questions about this recall, Golden State Medical Supply Inc., 1-805-477- 9866
March 2021
Class II
Fludeoxyglucose F 18 07631833450
Lack of Assurance of Sterility
If you have questions about this recall, Massachusetts General Hospital PET Center, 1- 617-726-2000
March 2021
Class II
Irinotecan Hydrochloride 05992371402
CGMP Deviations
If you have questions about this recall, Areva Pharmaceuticals Inc 1-855-853-4760
March 2021
Class II
Imatinib Mesylate 04359834490 00435984431
Failed Dissolution Specifications
If you have questions about this recall, Dr. Reddy’s Laboratories, Inc. 1-888-375-3784
March 2021
Class II
Epoprostenol Sodium 00703199501
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
March 2021
Class II
Vecuronium Bromide 00703291401 00703291403
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
March 2021
Class II
Toposar 00703565701
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800
March 2021
Class II
Metoclopramide Injection 00703450201 00703450204
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800.
March 2021
Class II
Leucovorin Calcium 00703514001 00703514501
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800.
March 2021
Class II
MethyIPREDNISolone Acetate 00703003101 00703005101 00703005104 00703004501 00703004301 00703006301
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800.
March 2021
Class II
Epoprostenol Sodium 00703198501
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800.
March 2021
Class II
Sterile Diluent for Epoprostenol Sodium 0703925801
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA 1-800-545-8800.
March 2021
Class II
Desmopressin Acetate 00703505101 00703505103
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800.
March 2021
Class II
Dacarbazine 00703507501 00703507503
Lack of Assurance of Sterility
If you have questions about this recall, Teva Pharmaceuticals USA, 1-800-545-8800.
March 2021
Class II
Cisatracurium Besylate 07128871206
Labeling: Label mix-up
If you have questions about this recall, Meitheal Pharmaceuticals Inc, 1-224-443-4617.
March 2021
Class I
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz 05436540033
Non-sterility
If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800.
March 2021
Class I
ChlroraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. Oz 05436540001
Non-sterility
If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800.
March 2021
Class I
ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution – Hi- Lite Orange 0.10 fl. Oz
Microbial Contamination
Class I
05436540011
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl 05436540032
Non-sterility
If you have questions about this recall, CareFusion 213, LLC, 1- 201-847-6800.
March 2021
Class I
Meclizine HCl Tablets 05253612901 05253613301
Failed Dissolution Specifications
If you have questions about this recall, Wilshire Pharmaceuticals, Inc, Ltd, 1-877-495-6856.
February 2021
Class II
Cephalexin for Oral Suspension 06787754568
CGMP Deviations
If you have questions about this recall, Alkem Laboratories, Ltd, 1-636- 343-5664.
February 2021
Class II
Metformin Hydrochloride Extended-Release Tablets 02903305601
CGMP Deviations
If you have questions about this recall, Nostrum Laboratories Inc, 1-816- 841-4636.
February 2021
Class II
Nortriptyline HCl Capsules 05167240011
CGMP Deviations
If you have questions about this recall, Taro Pharmaceuticals U.S.A., Inc.,1-800-544-1449 ext 6066.
February 2021
Class II
Acetaminophen Injection 05515030701
Discoloration and failed pH specifications
If you have questions about this recall, AuroMedics Pharma LLC, 1-732-839-9400 ext 2.
February 2021
Class II
Ketorolac Tromethamine Injection 06332316201
Presence of Particulate Matter
If you have questions about this recall, Fresenius Kabi USA, 1- 800-551-7176.
February 2021
Class I
Nitrofurantoin Capsules 06808444601 06808444611
Failed Dissolution Specifications
If you have questions about this recall, American Health Packaging, 1-800- 707-4621.
January 2021
Class II
Chlorhexidine Gluconate 06809402861
cGMP Deviations
If you have questions about this recall, Precision Dose Inc., 1-800-397- 9228.
January 2021
Class II
Metformin Hydrochloride 02903305601
cGMP Deviations
If you have questions about this recall, Nostrum Laboratories Inc, 1-816- 308-4941.
January 2021
Class II
Paroex (Chlorhexidine Gluconate) 05237602102 05237602104
cGMP Deviations
If you have questions about this recall, Sunstar Americas, Inc., 1-800-528- 8527
January 2021
Class II
Levetiracetam 05038324116
Defective container
If you have questions about this recall, Akorn, Inc, 1-800-932-5676, Prompt 2
January 2021
Class II
Cephalexin 06787754488 06787754468
Failed Impurity/Degradation Specifications
If you have questions about this recall, Ascend Laboratories LLC, 1-877-272-7901.
January 2021
Class II
Esomeprazole Magnesium 06909752734 06909752834 06909752934
Cross-contamination with other products
If you have questions about this recall, CIPLA, 1-866-604-3268.
January 2021
Class II
Cephalexin 06787754568 06909752734
Failed Impurity/Degradation Specifications
If you have questions about this recall, Ascend Laboratories LLC, 1-877- 272-7901.
January 2021
Class II
Auryxia (ferric citrate) 05992263101
CGMP Deviations
If you have questions about this recall, Akebia Therapeutics dba Keryx Biopharmaceuticals, Inc, 1-617-871-2098.
December 2020
Class II
Hydroxyzine Hydrochloride 06043215004 06043215016
Failed Impurities/Degradation Specification
If you have questions about this recall, Morton Grove Pharmaceuticals, Inc., 1- 847-967-5600, Prompt 4.
December 2020
Class II
Vumerity (diroximel fumarate) 06440602001
Failed dissolution specifications
If you have questions about this recall, Biogen MA Inc., 1-844- 477-4672.
December 2020
Class II
Lansoprazole Delayed-Release 06838277177
Failed Dissolution Specifications
If you have questions about this recall, Zydus Pharmaceuticals (USA) Inc, 1-877-993- 8779, Prompt 2.
December 2020
Class II
Lansoprazole Delayed-Release 06838277277
Failed Dissolution Specifications
If you have questions about this recall, Zydus Pharmaceuticals (USA) Inc, 1-877-993- 8779, Prompt 2.
December 2020
Class II
Sildenafil 04229174801
Product mix-up
If you have questions about this recall, AVKARE Inc., 1-855-361- 3993.
December 2020
Class II
TraZODONE Hydrochloride 04229183410
Product mix-up
If you have questions about this recall, Shilpa Medicare Limited, 1-732-637-1971.
December 2020
Class II
Imatinib Mesylate 07248520330
GMP Deviations
If you have questions about this recall, Shilpa Medicare Limited, 1-732-637-1971.
December 2020
Class II
Imatinib Mesylate 07248520290d
GMP Deviations
If you have questions about this recall, Shilpa Medicare Limited, 1-732-637-1971.
December 2020
Class II
Anagrelide 01366846201
Failed Dissolution Specifications
If you have questions about this recall, Torrent Pharma Inc, 1- 888-280-2040.
December 2020
Class I
(Lidocaine HCL 2%) Topical Anesthetic Hydrogel 06697710703
Microbial Contamination of Non- Sterile Drug Product
If you have questions about this recall, MPM Medical LLC, 1-800- 232-5512.
December 2020
Class I
Chlorhexidine Gluconate 007016602715
Microbial contamination of non-sterile products
If you have questions about this recall, Lohxa LLC, 1-800-641- 5564.
December 2020
Class I
Tizanidine 06787761415
Failed Dissolution Specifications
If you have questions about this recall, Ascend Laboratories LLC, 1-877- 272-7901.
December 2020
Class I
Aripiprazole 00904651204
Failed Dissolution Specifications
If you have questions about this recall, The Harvard Drug Group, 1- 800-875-0123.
December 2020
Class II
ARIPIPRAZOLE 06042944930
FAILED DISSOLUTION SPECIFICATIONS
If you have questions about this recall, Golden
December 2020
Class II
State Medical Supply Inc., 1-805-477-9866.
Paroex (chlorhexidine gluconate) 05237602102 05237602104
Microbial Contamination of Non- sterile Product
If you have questions about this recall, Sunstar Americas, Inc., 1-609-751- 9600.
December 2020
Class I
Levetiracetam 07193006352
Presence of foreign tablet
If you have questions about this recall, Jubilant EYWA PHARMA INC, 1- 609-751-9600.
December 2020
Class II
clomiPRAMINE Hydrochloride 05974671130
Failed Tablet
If you have questions about this recall, Jubilant Cadista Pharmaceuticals, Inc., 1-800-308-3985.
December 2020
Class II
Lansoprazole Delayed-Release Orally Disintegrating Tablets 06838277177
Failed Dissolution Specifications
If you have questions about this recall, Zydus Pharmaceuticals, 1-877- 993-8779.
November 2020
Class II
Lansoprazole Delayed-Release Orally Disintegrating Tablets 06838277277
Failed Dissolution Specifications
If you have questions about this recall, Zydus Pharmaceuticals, 1-877- 993-8779.
November 2020
Class II
Mesalamine Delayed-Release Tablets 00591224522
Failed Dissolution Specifications
If you have questions about this recall, Teva Pharmaceuticals USA,1- 888-838-2872 ext 5
November 2020
Class II
metformin HCL ER 750 mg 04306390230 04306390260
CGMP Deviations
If you have questions about this recall, PD-Rx Pharmaceuticals, Inc., 1- 800-299-7379
November 2020
Class II
metformin HCL ER 500 mg tablets 07278900930 07278900960 07278900993 07278900990
CGMP Deviations
If you have questions about this recall, PD-Rx Pharmaceuticals, Inc., 1- 800-299-7379
November 2020
Class II
Metformin Hydrochloride Extended-Release Tablets 02903305501
CGMP Deviations
If you have questions about this recall, Nostrum Laboratories Inc, 1-816- 841-4636.
November 2020
Class II
Metformin Hydrochloride Extended-Release Tablets 02903305601
CGMP Deviations
If you have questions about this recall, Nostrum Laboratories Inc, 1-816- 841-4636.
November 2020
Class II
Chlorhexidine Gluconate 20% 05329600120
Discoloration
If you have questions about this recall, Medichem S.A., 1-201- 420-1800
November 2020
Class II
Metformin Hydrochloride Extended-Release Tablets 04948362401
CGMP Deviations
If you have questions about this recall, Medichem S.A., 631-753- 9090 ext. 160
November 2020
Class II
Metformin Hydrochloride – Extended-Release Tablets 04948362309 04948362301 04948362350 04948362310 04948362350
CGMP Deviations
If you have questions about this recall, Marksans Pharma Limited, 631-753-9090; ext. 160
November 2020
Class II
Metformin HCL E/R 500 mg 07218906490
CGMP Deviations
If you have questions about this recall, Direct Rx, 1-678-619-5510
November 2020
Class II
Metformin Hydrochloride Extended-Release Tablets, USP 500 mg 07093430930 07093430960 07093430990 07093430998
CGMP Deviations
If you have questions about this recall, Denton Pharma, Inc., 1-800-722- 0772.
November 2020
II
Metformin Hydrochloride Extended-Release Tablets 07093433430
CGMP Deviations
If you have questions about this recall, Denton Pharma, Inc., 1-800-722- 0772.
November 2020
II
Mesalamine Delayed-Release Tablets 04229156412
Failed Dissolution Specifications
If you have questions about this recall, AVKARE Inc., 1-931-292-6222.
November 2020
II
Metformin Hydrochloride Extended-Release 750 mg 70518248000
CGMP Deviations
If you have questions about this recall, RemedyRepack Inc., 1- 866-845-3791
November 2020
II
Hydrocortisone butyrate Cream, 0.1% 06868227015
SUBPOTENT DRUG
If you have questions about this recall, Boehringer Ingelheim Pharmaceuticals, Inc., 1- 908-927-1400
November 2020
II
Catapres (clonidine hydrochloride, USP) 0.3 mg 00597001101
An extraneous peak was observed for dissolution testing.
If you have questions about this recall, Boehringer Ingelheim Pharmaceuticals, Inc., 1- 800-243-0127
November 2020
II
Catapres (clonidine hydrochloride, USP) 0.2 mg 00597000701
An extraneous peak was observed for dissolution testing.
If you have questions about this recall, Boehringer Ingelheim Pharmaceuticals, Inc., 1- 800-243-0127
November 2020
II
Catapres (clonidine hydrochloride,USP) 0.1 mg 0597000601
An extraneous peak was observed for dissolution testing.
If you have questions about this recall, Boehringer Ingelheim Pharmaceuticals, Inc., 1- 800-243-0127
November 2020
II
NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 04219232701
Subpotent Drug
If you have questions about this recall, Acella Pharmaceuticals, LLC1- 800-541-4802 ext 1,
October 2020
I
NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 04219232801
Subpotent Drug
If you have questions about this recall, Acella Pharmaceuticals, LLC1- 800-541-4802 ext 1,
October 2020
I
Losartan Pot/HCTZ 50/12.5 mg 06191904090
CGMP Deviations
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
October 2020
II
RIOMET ER (metformin hydrochloride for extended-release oral suspension) 01063101917
CGMP Deviations
If you have questions about this recall, Sun Pharmaceutical Industries, Inc., 1-800-818-4555
October 2020
II
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035% 05977992001
CGMP Deviations
If you have questions about this recall, Akorn, Inc, 1-800-932-5676.
October 2020
II
Potassium Chloride Extended-Release Tablets 06438086006
Failed Dissolution Specifications
If you have questions about this recall, Strides Inc.1-609-773- 5000.
October 2020
II
Nature-Throid, 1.5 Grain, (97.5 mg), (Thyroid U.S.P. 1.5 gr. (97.5mg)/Liothyronine (T3) 13.5mcg/Levothyroxine (T4) 57mcg 68788760509
Subpotent Drug
If you have questions about this recall, Preferred Pharmaceuticals, Inc. 1- 714-777-3729.
September 2020
II
Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg 68788760409 68788760401
Subpotent Drug
If you have questions about this recall, Preferred Pharmaceuticals, Inc. 1- 714-777-3729.
September 2020
II
Nature-Throid, 3/4 Grain (48.75 mg) Thyroid U.S.P. 3/4 gr. (48.75 mg)/Liothyronine (T3) 6.75mcg/Levothyroxine (T4) 28.5mcg 68788686009
Subpotent Drug
If you have questions about this recall, Preferred Pharmaceuticals, Inc. 1- 714-777-3729.
September 2020
II
Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch 68788928301
Subpotent Drug
If you have questions about this recall, Preferred Pharmaceuticals, Inc. 1- 714-777-3729.
September 2020
II
WP Thyroid, Westhroid Pure, 2 Grain (130 mg) Thyroid USP 06472759502 06472759504 06472759505 06472759506 06472759501
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
WP Thyroid, Westhroid Pure, 1.75 Grain (113.75 mg) Thyroid USP 06472761502
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
06472761504 06472761505 06472761506 06472761501
WP Thyroid, Westhroid Pure, 1.5 Grain (97.5 mg) Thyroid USP 06472758502 06472758504 06472758505 06472758506 06472758501
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
WP Thyroid, Westhroid Pure, 1.25 Grain (81.25 mg) Thyroid USP 06472760502 06472760504 06472760505 06472760506 06472760501
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
WP Thyroid, Westhroid Pure, 1 Grain (65 mg) Thyroid USP 06472757502 06472757504 06472757505 06472757506 06472757501
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP 06472755502 06472755504 06472755505 06472755506 06472755501
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg 06472754504 06472754505 06472754506 06472754501 06472754502
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
Nature-Throid, Thyroid USP [liothyronine (T3) 27 mcg and levothyroxine (T4) 114 mcg 06472733124 06472733125 06472733126 06472733121 06472733122
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg 06472733104 06472733105
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
06472733106 06472733101 06472733102
Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg 06472733094 06472733095 06472733096 06472733091 06472733092
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
Nature-Throid, Thyroid USP [liothyronine (T3) 18 mcg and levothyroxine (T4) 76 mcg 06472733084 06472733085 06472733086 06472733081 06472733082
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
Nature-Throid, Thyroid USP [liothyronine (T3) 15.75 mcg and levothyroxine (T4) 66.5 mcg 06472733074 06472733075 06472733076 06472733071 06472733072
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
Nature-Throid, Thyroid USP [liothyronine (T3) 13.5 mcg and levothyroxine (T4) 57 mcg 06472733054 06472733055 06472733056 00472733051 06472733052
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
Nature-Throid, Thyroid USP [liothyronine (T3) 11.25 mcg and levothyroxine (T4) 47.5 mcg], 1.25 Grain (81.25 mg) 06472733034 06472733035 06472733036 06472733031 06472733032
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
Nature-Throid, Thyroid USP [liothyronine (T3) 4.5 mcg and levothyroxine (T4) 19 mcg 06472732994 06472732995 06472732996 06472732991 06472732992
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
Nature-Throid, Thyroid USP [liothyronine (T3) 6.75 mcg 06472733024 06472733025 06472733026 06472733021 06472733022
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
Nature-Throid, Thyroid USP [liothyronine (T3) 9 mcg and levothyroxine (T4) 38 mcg 06472733004 06472733005 06472733006 06472733001 06472733002
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
II
Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg 06472733054 06472733055 06472733056 06472733051 06472733051
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
I
Nature Throid, 2 Grain (130 mg) Thyroid USP [Liothyronine (T3) 18 mcg, Levothyroxine (T4) 76 mcg 06472733084
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
I
06472733081
Nature Throid, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg 06472733031
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
I
Nature Throid, 3/4 Grain (48.75 mg) Thyroid USP [Liothyronine (T3) 6.75 mcg, Levothyroxine (T4) 28.5 mcg 06472733021 06472733022
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
I
Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg 06472732996 06472732991
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
I
WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg 06472755504 06472755506 06472755501
Subpotent Drug
If you have questions about this recall, RLC Labs Inc., 1-877-797-7997
September 2020
I
Sulfamethoxazole and Trimethoprim Tablets
Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).
If you have questions about this recall, Aurobindo Pharma USA Inc., 1-866-850-2876
September 2020
II
BusPIRone Hydrochloride Tablets
Failed Impurity /Degradation Specifications
If you have questions about this recall, Par Pharmaceutical Inc., 1-845-573-5500
September 2020
II
Buprenorphine HCl Injection
Sub-potent Drug: Out-of-Specification assay results found at 3-month stability testing.
If you have questions about this recall, West-Ward Pharmaceuticals , 1-877-845-0689.
September 2020
II
Metformin Hydrochloride Extended-Release Tablets 07638512810
CGMP Deviations
If you have questions about this recall, BAYSHORE PHARMACEUTICALS, 1- 877-372-6093
September 2020
II
Metformin Hydrochloride Extended-Release Tablets 07638512901
CGMP Deviations
If you have questions about this recall, BAYSHORE PHARMACEUTICALS, 1- 877-372-6093
September 2020
II
Cephalexin for Oral Suspension 00093417773
Labeling: Label Error on Declared Strength
If you have questions about this recall, Teva Pharmaceuticals USA,1- 888-838-2872 ext 5
September 2020
II
Lidocaine Patch 5% 00591352530
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton
If you have questions about this recall, Teva Pharmaceuticals USA,1- 888-838-2872 ext 5
August 2020
II
Mibelas 24 Fe 06818091113
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test
If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3
August 2020
II
Nystatin Oral Suspension 00121061016
Subpotent drug: Out of specification for assay at the 15-month test interval
If you have questions about this recall, PAI Holdings, LLC. dba Pharmaceutical Associates Inc1-864-277- 7282 ext 0
August 2020
II
Ear Pain MD Pain Relief Drops 07242900708
cGMP Deviations.
If you have questions about this recall, Eosera, Inc.1-844-732-7929
August 2020
II
Ear Pain MD Pain Relief Drops 07242900722
cGMP Deviations.
If you have questions about this recall, Eosera, Inc.1-844-732-7929
August 2020
II
Heparin Sodium 70004065046
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
If you have questions about this recall, SCA Pharmaceuticals1-877- 550-5059
August 2020
II
BD ChloraPrep Clear 5436540032213
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
If you have questions about this recall, CareFusion LLC1-201- 847-6800.
August 2020
I
ChloraPrep With Tint 05436540011
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
If you have questions about this recall, CareFusion LLC1-201- 847-6800.
August 2020
I
ChlroraPrep One-Step 05436540001
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
If you have questions about this recall, CareFusion LLC1-201- 847-6800.
August 2020
I
DDAVP Nasal 05556625000
Superpotent Drug
If you have questions about this recall, Ferring Pharmaceuticals Inc1- 888-337-7464 ext2
August 2020
I
Desmopressin Acetate 06991850105
Superpotent Drug
If you have questions about this recall, Ferring Pharmaceuticals Inc1- 888-337-7464 ext2
August 2020
I
STIMATE (desmopressin acetate) 00053687100
Superpotent Drug
If you have questions about this recall, Ferring Pharmaceuticals Inc1- 888-337-7464 ext2
August 2020
I
Hydrochlorothiazide 16729018317
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches
If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545.
August 2020
II
Hydrochlorothiazide (HCTZ) 29300012810
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches
If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545.
August 2020
II
Hydrochlorothiazide 16729018417
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches
If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545.
August 2020
II
Thyroid 1 Grain 64727330002
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches
If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545.
August 2020
II
Thyroid 1 Gr 64727330001
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches
If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545.
August 2020
II
Thyroid Neutral 64727330802
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches
If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545.
August 2020
II
Topiramate 47335070713
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches
If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545.
August 2020
II
Phendimetrazine 00702007710
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches
If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545.
August 2020
II
Phendimetrazine 69543041011
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches
If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545.
August 2020
II
Phendimetrazine 69543040911
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches
If you have questions about this recall, Calvin Scott & Company, Inc.1- 800-545-6545.
August 2020
Class II
Prednisone 00527293137
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets
If you have questions about this recall, Lannett Company, Inc.1-215-333- 9000
August 2020
Class II
Elitek (rasburicase) 00024515175
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing
If you have questions about this recall, .Sanofi- Aventis U.S. LLC1-800- 981-2491 ext 2
August 2020
Class II
Mibelas 24 Fe 06818091111
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test
If you have questions about this recall, Lupin Pharmaceuticals Inc.1- 410-576-2000 ext 3
August 2019
Class II
Daptomycin 06745781350
Presence of Particulate Matter
If you have questions about this recall, Mylan Institutional LLC, 1-800- 796-9526 ext 1.
August 2020
Class II
Fentanyl Citrate 00409909412
Lack of Assurance of Sterility
If you have questions about this recall, Pfizer Inc.,1-800-438-1985.
August 2020
Class II
Lisinopril 06800133408
Presence of Foreign Tablets/Capsules
If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617 ext 2.
August 2020
Class II
Cefdinir 06818072320
Superpotent Drug
If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617 ext 2.
July 2020
Class II
Metformin HCl Extended Release Tablets
CGMP Deviation
If you have questions about this recall, Preferred Pharmaceuticals, Inc, 1- 714-777-3729.
July 2020
Class II
Metformin Hydrochloride Extended-Release 00904579461
CGMP Deviation
If you have questions about this recall, The Time-Cap, Labs Inc, 1- 631-753-9090 ext 160
July 2020
Class II
Clozapine Tablets 06586284605
Presence of foreign tablet
If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876
July 2020
Class II
Metformin Hydrochloride Extended-release Tablets 06818033607
CGMP Deviations
If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617.
July 2020
Class II
Aripiprazole Tablets 06233209730
Labeling: Label mix up
If you have questions about this recall, Alembic Pharmaceuticals Limited, 1-908-393-9604.
July 2020
Class II
Nystatin Cream 00316022130 00316022115
Subpotent Drug
If you have questions about this recall, Crown Laboratories, Inc., 1-800- 877-8869.
July 2020
Class II
metFORMIN HCL ER 07278900930 07278900960 07278900990 07278900993 49483062301
CGMP Deviations
If you have questions about this recall, Amneal Pharmaceuticals., 1-833- 582-0812.
July 2020
Class II
Metformin Hydrochloride Extended-Release Tablets 04948362301
CGMP Deviations
If you have questions about this recall, Time- Cap Labs,1-631-753-9090 ext 160
July 2020
Class II
Metformin Hydrochloride Extended – Release Tablets 06203757101 06203757110 06203757701 06203757710
CGMP Deviations
If you have questions about this recall, Teva Pharmaceuticals USA, 1- 800-545-8800.
July 2020
Class II
Metformin Hydrochloride Extended-Release Tablets 53746017801 06516217809 06516217850 06516217810 53746017901 06516217910 00537460178 53746017805 53746017810 65162017811 00537460179 65162017901
CGMP Deviations
If you have questions about this recall, Amneal Pharmaceuticals, 1-833- 582-0812
July 2020
Class II
Heparin Sodium 70004065046
Subpotent Drug
If you have questions about this recall, SCA Pharmaceuticals, 1-877- 550-5059.
June 2020
Class II
Irinotecan HCL Injection 00143958301
Defective Container
If you have questions about this recall, West- Ward Pharmaceutical Corp, 1-877-845-0689.
June 2020
Class II
Irinotecan HCL Injection 00143970101
Defective Container
If you have questions about this recall, West- Ward Pharmaceutical Corp, 1-877-845-0689.
June 2020
Class II
metFORMIN HCL ER 04306342830 04306342860 04306342890 04306342898 04306342893 53746017805
CGMP Deviations
If you have questions about this recall, Amneal Pharmaceuticals, 1-833- 582-0812
June 2020
Class II
Metformin Hydrochloride Extended-Release Tablets 05026853115 04229161090 04229161018 04229161036 04229161010
CGMP Deviations
If you have questions about this recall, AVKARE Inc., 1-931-292-6222.
June 2020
Class II
Metformin Hydrochloride Extended-Release Tablets 04229161190 04229161118 04229161150
CGMP Deviations
If you have questions about this recall, AVKARE Inc., 1-931-292-6222.
June 2020
Class II
Metformin Hydrochloride Extended-Release Tablets 06050502601
CGMP Deviations
If you have questions about this recall, Apotex Inc., 1-800-268-4623.
June 2020
Class II
Gaviscon Liquid Antacid Extra Strength, Cool Mint 00135009541
Labeling: Label lacks warning
If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-743- 4014
June 2020
Class II
Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry 00135057441
Labeling: Label lacks warning
If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-743- 4014
June 2020
Class II
Gaviscon Regular Strength Liquid Antacid Cool Mint 00135009441
Labeling: Label lacks warning
If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-743- 4014
June 2020
Class II
Gaviscon Regular Strength Liquid Antacid Cool Mint 00135009442
Labeling: Label lacks warning
If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings Inc., 1-800-743- 4014
June 2020
Class II
oxyTOCIN 30 Units 070092106807
Subpotent drug
If you have questions about this recall, QuVa Pharma, Inc., 1-888-339- 0874.
June 2020
Class II
Lisinopril 06818051303
Product Mix Up
If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617.
June 2020
Class II
Unasyn (ampicillin sodium/sulbacatam) 00049001381 00049001383
Presence of Particulate Matter
If you have questions about this recall, Pfizer Inc., 1-800-879-3477.
June 2020
Class II
Doxycycline Hyclate 06258469311
Failed dissolution specification
If you have questions about this recall, American Health Packaging, 1-614- 492-8177.
June 2020
Class II
Ketorolac Tromethamine 06332316200 06332316203
Presence of Particulate Matter
If you have questions about this recall, Fresenius Kabi USA, LLC, 1-847-550-2300.
June 2020
Class II
Doxycycline Hyclate 00904043004 00904043006
Failed Dissolution Specification
If you have questions about this recall, The Harvard Drug Group, 1- 732-542-1191.
June 2020
Class II
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 00555097102 00555097302 00555077702
Some bottles may contain mixed strengths of the product.
If you have questions about this recall, Teva Pharmaceuticals USA, 1- 800-545-8800.
June 2020
Class II
Estriol USP Micronized 71092997702
Failed impurities/ degradation specifications
If you have questions about this recall, TRIOVA PHARMACEUTICALS LLC, 1-539-777-0720.
June 2020
Class II
NP Thyroid 90 04219233101
Superpotent Drug
If you have questions about this recall, Acella Pharmaceuticals, LLC 1- 800-541-4802.
June 2020
Class I
NP Thyroid 60 04219233001
Superpotent Drug
If you have questions about this recall, Acella Pharmaceuticals, LLC 1- 800-541-4802.
June 2020
Class I
NP Thyroid 30 04219232901
Superpotent Drug
If you have questions about this recall, Acella Pharmaceuticals, LLC 1- 800-541-4802.
June 2020
Class I
Doxycycline Hyclate tablets 05528986606 05528986610 05528986614 05528986620 05528986628 05528986630 05528986660 05528986698 05528986671 05528986687 05528986674
Failed dissolution specifications
If you have questions about this recall, PD-Rx Pharmaceuticals, Inc., 1- 800-299-7379.
June 2020
Class II
Doxycycline Hyclate Tablets 00143211250 00143211205
Failed dissolution specification
If you have questions about this recall, West- Ward Columbus Inc, 1- 877-845-0689.
June 2020
Class II
Lactated Ringers 0409795309
Presence of Particulate Matter
If you have questions about this recall, Hospira Inc., 1-877-946-7747.
May 2020
Class II
Aloprim (allopurinol sodium) 06745718750
Discoloration
If you have questions about this recall, Mylan Pharmaceuticals Inc., 1- 551-233-2700.
May 2020
Class II
Infuvite PEDiatric Pharmacy 05464356470
Defective container
If you have questions about this recall, Sandoz, Inc, 1-609-627-8500
May 2020
Class II
Epinephrine Injection 00093598627
CGMP Deviations
If you have questions about this recall, Teva Pharmaceuticals USA, 1- 888-838-2872.
May 2020
Class II
Nizatidine 06084630115
CGMP Deviations
If you have questions about this recall, Amneal Pharmaceuticals of New York, 1-631-952-0214
May 2020
Class II
Ceftazidime 00264314511
Failed Stability Specifications
If you have questions about this recall, Braun Medical Inc., 1-949-660- 2000
May 2020
Class II
Lisinopril Tablets 68180098103
Product Mix-Up
If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617
April 2020
Class II
Cefixime for Oral Suspension 06818040501
Subpotent Drug
If you have questions about this recall, Lupin Pharmaceuticals Inc., 1- 866-587-4617
April 2020
Class II
Daytrana 06896855553
Defective Delivery System
If you have questions about this recall, Noven Therapeutics, LLC, 1-305- 253-5099.
April 2020
Class II
Daytrana 06896855543
Defective Delivery System
If you have questions about this recall, Noven Therapeutics, LLC, 1-305- 253-5099.
April 2020
Class II
Daytrana 06896855523
Defective Delivery System
If you have questions about this recall, Noven Therapeutics, LLC, 1-305- 253-5099.
April 2020
Class II
Acetaminophen and Codeine Phosphate 01310705801
CGMP Deviations
If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876.
April 2020
Class II
Acetaminophen and Codeine Phosphate 01310705999
CGMP Deviations
If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876.
April 2020
Class II
Acetaminophen and Codeine Phosphate 01310706001
CGMP Deviations
If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876.
April 2020
Class II
Gabapentin Capsules 06586219899
CGMP Deviations
If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876.
April 2020
Class II
Levetiracetam Tablet 06586224708
CGMP Deviations
If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876.
April 2020
Class II
Simvastatin 06586205390
CGMP Deviations
If you have questions about this recall, Aurobindo Pharma USA, Inc 1-866-850-2876.
April 2020
Class II
Mirtazapine 01310703134 06586219899
CGMP Deviations
If you have questions about this recall, Aurobindo Pharma USA, Inc 1-866-850-2876.
April 2020
Class II
Phentermine Hydrochloride 06586205390 06586219899
CGMP Deviations
If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876.
April 2020
Class II
Oxycodone and Acetaminophen 01310704601 6586219899
CGMP Deviations
If you have questions about this recall, Aurobindo Pharma USA, Inc, 1-866-850-2876.
April 2020
Class II
Losartan Potassium 06042931630 06042931690 06042931610
CGMP Deviations
If you have questions about this recall, Golden State Medical Supply Inc., 1-805-477-9866 Ext 4.
April 2020
Class II
Estradiol 06327599008 06327599005 06327599004
CGMP Deviations
If you have questions about this recall, B & B Pharmaceuticals, Inc., 1- 800-499-3100.
April 2020
Class II
Acetaminophen and Codeine Phosphate 300/30mg 52959000310 52959000312 52959000314 52959000315 52959000316 52959000320 52959000330 52959000360
CGMP Deviations
If you have questions about this recall, H.J. Harkins Co, 1-805-929- 1333
April 2020
Class II
succinylcholine Chloride 07101934104
lack of sterility assurance.
If you have questions about this recall, PharMEDium Services, 1- 800-523-7749 Option 1
April 2020
Class II
rocuronium Bromide 07101932110 07101932105
lack of sterility assurance.
If you have questions about this recall, PharMEDium Services, 1- 800-523-7749 Option 1
April 2020
Class II
Phytonadione Injectable Emulsion 04359840511
Defective Container
If you have questions about this recall, Dr. Reddy’s Laboratories Inc., 1-888-375-3784
April 2020
Class I
nICARdipine HCl 07101920601
lack of sterility assurance.
If you have questions about this recall, PharMEDium Services, 1- 800-523-7749 Option 1
April 2020
Class II
Losartan Potassium tablets 00591374500 00591374600 00591374700
CGMP Deviations
If you have questions Teva Pharmaceuticals USA, 1-888-483-8279
April 2020
Class II
Losartan Potassium tablets 02315564503 02315564509 02315564510 02315564509 02315564603 02315564609 02315564610
CGMP Deviations
If you have questions Avet Pharmaceuticals, Inc., 1-800-967-5952 Option 1
April 2020
Class II
Lisinopril Tablets 06818098201
Presence of Foreign Tablet/ Capsule
If you have questions about this recall, Lupin Pharmaceuticals Inc., 1-800-399-2561
April 2020
Class II
HYDROmorphone in 0.9% Sodium Chloride HCl 06155316644
lack of sterility assurance.
If you have questions about this recall, PharMEDium Services, 1- 800-523-7749 Option 1
April 2020
Class II
Glycopyrrolate Tablets 49884006501
lack of sterility assurance.
If you have questions about this recall, Par Pharmaceutical Inc., 1- 845-573-5500
April 2020
Class II
fentaNYL Citrate Injection 06155330633 06155330328
lack of sterility assurance.
If you have questions about this recall, PharMEDium Services, LLC, 1-800-523-7749 Option 1
April 2020
Class II
fentaNYL Citrate 06155311350 06155367244
lack of sterility assurance.
If you have questions about this recall, PharMEDium Services, LLC, 1-800-523-7749 Option 1
April 2020
Class II
ePHEDrine Sulfate 07103000312 07103000309 07103000302 07103000109
lack of sterility assurance.
If you have questions about this recall, PharMEDium Services, LLC, 1-800-523-7749 Option 1
April 2020
Class II
C-*Vancomycin Opthal 14 mg drops 67457034001
Lack of Assurance of Sterility
If you have questions about this recall, Medical Center Pharmacy, Inc., 1- 800-523-7749
April 2020
Class II
C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL 63323001002
Lack of Assurance of Sterility
If you have questions about this recall, Medical Center Pharmacy, Inc., 1- 800-523-7749
April 2020
Class II
C-*Albumin Eye Drop 10% S 44206025105
Lack of Assurance of Sterility
If you have questions about this recall, Medical Center Pharmacy, Inc., 1- 800-523-7749
April 2020
Class II
*Morphine 2 mg/mL Cassette 00409113403
Lack of Assurance of Sterility
If you have questions about this recall, Medical Center Pharmacy, Inc., 1- 800-523-7749
April 2020
Class II
*Mitomycin 0.04% Ophth DR eye drops 067457051805
Lack of Assurance of Sterility
If you have questions about this recall, Medical Center Pharmacy, Inc., 1- 800-523-7749
April 2020
Class II
Nystatin Oral Suspension 00 21081016
SubPotent Drug: Low out-of- specification results for assay testing.
If you have questions about this recall, PAI Holdings, LLC. dba Pharmaceutical Associates Inc, 1-864- 277-7282.
April 2020
Class II
Theophylline (Anhydrous) Extended-Release 02903300101
CGMP Deviations: poor manufacturing practices resulted in Labeling
If you have questions about this recall, Jubilant Draximage Inc, 1-800- 361-2356.
April 2020
Class II
DRAXIMAGE DTPA (KIT FOR THE PREPARATION OF TECHNETIUM TC 99M PENTETATE INJECTION) 06517428805 06717528830
Failed Stability Specifications
If you have questions about this recall, Nostrum Laboratories Inc, 1-816- 841-4636.
April 2020
Class II
Advil Liqui-Gel Mini 160+20+20 CT 00573171559
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings, +44 20 8047 5000.
April 2020
Class II
Ibuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 00573019175 00573019150
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings, +44 20 8047 5000.
April 2020
Class II
Ibuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis 00573176989 00573176995
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings, +44 20 8047 5000.
April 2020
Class II
Advil Allergy & Congestion Relief 00573019610
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
If you have questions about this recall, Glaxosmithkline Consumer Healthcare
April 2020
Class II
Holdings, +44 20 8047 5000.
Phenylephrine 10 mg tablets. 00573019620
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings, +44 20 8047 5000.
April 2020
Class II
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg 00573019610
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
If you have questions about this recall, Glaxosmithkline Consumer Healthcare Holdings, +44 20 8047 5000.
April 2020
Class II
Doxycycline 06330461501 06330461650
CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
If you have questions about this recall, Sun Pharmaceutical Industries, Inc., 1-800-818-4555.
March 2020
Class II
Solifenacin Succinate 05199189333 05199189390
CGMP Deviations: During manufacturing, Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets.
If you have questions about this recall, Breckenridge Pharmaceutical, Inc, 1- 860-828 – 8140.
March 2020
Class II
Atorvastatin Calcium 06330482905
Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of Atorvastatin Calcium Tablets USP 40 mg.
If you have questions about this recall, Sun Pharmaceutical Industries, Inc., 1-800-818-4555.
March 2020
Class II
Pantoprazole Sodium Delayed-Release
CGMP Deviations: Presence of dark brown discoloration on edges of tablets
If you have questions about this recall, Jubilant Cadista Pharmaceuticals, Inc., 1-410- 860-2836.
March 2020
Class II
Sotalol HCL 00378512301
Presence of particulate matter. presence of metal particles.
If you have questions about this recall, Mylan Pharmaceuticals Inc., 1- 551-233-2700.
March 2020
Class II
Daytrana (methylphenidate transdermal system) 06896855523 06896855533 06896855543 06896855553
Defective Delivery System: Out of specification for mechanical peel and shear.
If you have questions about this recall, Noven Therapeutics, LLC, 1 – 800-796-9526.
March 2020
Class II
Ranitidine 00113785282 05977954082 03780850782 02113011682 00363085282
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 05977995001
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 00113785201 06839185256 05977954001 05591001101
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
06398185256 03014260056 04125085201 01182208524 00363085201
Ranitidine 04903580075 01167395075
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 04903560875 01167302375
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 00113795009 05977995009 04903580009 04612253309 03014289109 03680095009 01167395009 00363095009
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 04152039209 05977954009 05531985209 04612253209 03780850709 04934810954
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
0 4125089109 01182208523 03701285209 05059485209 04934810954 01167385209 00363085209
Ranitidine 05591085271 04612222471 00113085271 06925604171 03014260071 00904671651 04125085271 05606209971 01182208522 02113011671 03680085271
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 01167395058
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 04125095002 01182209500 03701295062 02113056862
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
03680095062 00363095002
Ranitidine 04699485262 04152039202 05977954002 05591085202 04116385262 04903560802 05530185202 05531985202 04612222462 00113085262 06925604162 04934810904 03014260002 00904671624 04125085202 05606209902 01182208525 01020285262 04119085262 03701285262 02113011602 05059485202 06201102821 03680085202
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
01167302302 00363085262
Ranitidine 00113085251 00363085251
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 06984229306
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 03780887647 04903587647
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 03780887647 04903587647
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 00113787627 07000003752 01167387627 00363187627
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 06201102832 09046715524 00125025272 04934813612
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Ranitidine 06984229365 04116393165 05531987665 00113087665 03780887665 06925687665 06201102831 06201102831 00904671546 02113011865 04934813644 01167387665 00363187665
CGMP Deviation; Possible contamination with impurity N- nitrosodimethylamine.
If you have questions about this recall, Perrigo Company PLC, 1-800- 719-9260
March 2020
Class II
Lisinopril/HCTZ 68180051902 70518038203
Presence of Foreign Tablets/Capsules
If you have questions about this recall, RemedyRepack Inc., 1- 866-845-3791
March 2020
Class II
Calcium Chloride Injection 07128302253
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 1,000 IU/ML INJECTABLE 07128302103
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Zinc Chloride Injection, ZINC CHLORIDE 10MG/ML INJECTABLE 07128302243
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Cholecalciferol (Vitamin D3) Injection, VITAMIN D3 [P] 100,000 IU/ML INJECTABLE 07128302513
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Elelyso (taliglucerase alfa) for injection 069010601
Lack of Assurance of Sterility
If you have questions about this recall, Pfizer Labs, 1-877-225-9750
March 2020
Class II
Mesalamine Delayed-Release Tablets591224522
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
If you have questions about this recall, Teva Pharmaceuticals USA, Inc, 1-877-685-8222
March 2020
Class II
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA7 0128306282
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA 07128306341
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP For IM IA 7128306251
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA7128306352
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA7128306331
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
[10ML] 40MG/5MG/ML INJ SUSP, For IM, IA 07128306321
Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE 07128305302
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/ML INJ SUSP, For IM, IA 07128306331
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/ML INJ SUSP, For IM, IA 07128306352
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE Diacetate [10ML] CMC 10MG/ML INJ SUSP, For IM, IA
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
07128306251l
Testosterone Cypionate/Progesterone Injection, TESTOSTERONE CYP/PROGESTERONE [2ML] 200MG/2.5MG/ML INJECTABLE7128305312
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Testosterone Cypionate Injection,TESTOSTERONE CYP IN GRAPESEED OIL [10ML] 200 MG/ML INJECTABLE 07128305301
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Selenium Injection, SELENIUM 200MCG/ML INJECTABLE 07128302273
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Super MIC Injection, SUPER MIC* INJECTABLE 07128302343
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 20 MG/ML INJECTABLE
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
07128303361
Iohexol (PF) Injection,OMNIPAQUE INJECTION [5ML] 300MG I/ML INJECTABLE 07128314135
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Pyridoxine Hydrochloride Injection, PYRIDOXINE HCL 100 MG/ML INJECTABLE 07128302163
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Nicotinamide Adenine Dinucleotide (PF) Injection, NICOTINAMIDE ADENINE DINUCLEOTIDE (PF) 50 MG/ML INJECTABLE 07128303061
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
MIC-PLUS Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/ 5MG/ML INJECTABLE 07128302313
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Mitomycin-C (PF) Irrigation Solution, MITOMYCIN-C (PF) 0.5 MG/ML PF SYRINGE 07128308128
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
MIC-PLEX Injection, Vitamin Complex, MIC-COMBO* 25MG/50MG/50MG/1MG/20MG/ 5MG/ML INJECTABLE7128302333
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
MIC-B12 Injection, MIC-B12 25MG/50MG/50MG/1MG/ML INJECTABLE7128302303
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 50 MG/ML INJ SUSP, For IM, IA 07128306361
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP 07128306191
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension 07128306241
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE (PF) CMC [2ML] 80 MG/ML INJ SUSP, For IM, IA 07128306392
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Methylprednisolone Acetate/Bupivacaine Hydrochloride Injectable Suspension, METHYLPRED ACETATE/BUPIV [10ML] CMC 40MG/5MG/ML INJ SUSP, For IM, IA 07128306231
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Methylcobalamin Injection, METHYLCOBALAMIN [CD] 10MG/100MG/ML INJECTABLE, For IV, IM 07128303383
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Methylcobalamin Injection, METHYLCOBALAMIN 1 MG/ML INJECTABLE 07128303313
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Lysine Hydrochloride Injection, LYSINE HCL 100MG/ML INJECTABLE 07128303423
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Levocarnitine Injection, LEVOCARNITINE 500 MG/ML INJECTABLE 07128392603
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Lidocaine HCL (PF) Injection, LIDOCAINE HCL 4% (PF) 40 MG/ML INJECTABLE 07128310115
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Polyoxyl Lauryl Ether (Polidocanol) Injection, LAURETH-9 (POLIDOCANOL) 5% INJECTABLE 0712830603
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Hydroxyprogesterone Caproate Injection, HYDROXYPROGESTERONE CAPROATE [4ML] 250 MG/ML INJECTABLE
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
07128305325
Arginine Hydrochloride Injection, L-ARGININE HCL 100MG/ML INJECTABLE 07128303413
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Human Chorionic Gonadotropin (hCG) Injection, HCG [10ML] 1000 IU/ML INJECTABLE 07128305331
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Glycine Injection, GLYCINE USP 50MG/ML INJECTABLE 07128303443
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Glycerin (PF) Injection, GLYCERIN 99% INJECTABLE 07128304641
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE 07128312313
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Hydroxocobalamin Injection, HYDROXOCOBALAMIN 5MG/ML INJECTABLE 07128303393
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Glutathione Injection,GLUTATHIONE 200MG/ML INJECTABLE 07128312313
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE 07128302143
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP 07128306301
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Dexamethasone (LA) Injectable Suspension, DEXAMETHASONE LA [10ML] 16MG INJ SUSP 07128306301
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Deoxycholic Acid Sodium Injection, DEOXYCHOLIC ACID SODIUM 1.67% INJECTABLE 07128304623
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Cyanocobalamin Injection 07128303303
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV
March 2020
Class II
Pharmaceuticals, Inc, 1- 877-685-8222
Cyanocobalamin/Folinic Acid Injection, CYANOCOBALAMIN : FOLINIC ACID 2000 MCG/ML: 500MCG/ML INJECTABLE 07128303333
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Injection,COENZYME Q-10 20MG/ML OIL INJ SOLN 07128304111
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Biotin (Vitamin H) Injectable Suspension, BIOTIN 10 MG/ML INJ SUSP, For IM 07128302203
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [5ML] 7MG/ML INJ SUSP, For IM, IA 07128306215
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/ML INJ SUSP, For IM, IA 07128306211
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, 07128306202
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
B-COMPLEX 110 INJECTABLE 07128302123
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
AscorbiX (Buffered C) Injection, Ascorbix (50ML) 500MG/ML Injectable0 7128302265
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
AscorbiX (Buffered C) Injection, Ascorbix (30ML) 500MG/ML Injectable 07128302263
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 07128305462
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate Injection 07128305452
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Alprostadil (prostaglandin E1) 80 MCG/ML Injectable 07128305432
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Alprostadil (prostaglandin E1)150 MCG/ML Injectable 027128305382
Patent ductus arteriosus
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection 07128305502
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection 07128305492
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Alprostadil/Papaverine Hydrochloride/Phentolamine Mesylate/Atropine Sulfate Injection 07128305472
Lack of Assurance of Sterility
If you have questions about this recall, Fusion IV Pharmaceuticals, Inc, 1- 877-685-8222
March 2020
Class II
Phenytoin Oral Suspension 05167240691
Resuspension Problems
If you have questions about this recall, Taro Pharmaceuticals U.S.A, 1- 866-923-4914.
March 2020
Class II
Glycopyrrolate Tabs 00615817039
Failed Impurities
If you have questions about this recall, NCS Healthcare of Kentucky Inc, 1-270-651-6188
February 2020
Class II
Desmopressin Acetate Tablets 06808460421
GMP Deviations
If you have questions about this recall, American Health Packaging, 1-800- 967-5952.
February 2020
Class II
Desmopressin Acetate Tablets 06808460621
GMP Deviations
If you have questions about this recall, American Health Packaging, 1-800- 967-5952.
February 2020
Class II
Lamotrigine 05167241311
Cross contamination
If you have questions about this recall, Taro Pharmaceuticals U.S.A, 1- 866-923-4914.
February 2020
Class II
Methylphenidate hydrochloride Extended-Release 06203772501
Product bottle may be absent of desiccant.
If you have questions about this recall, Teva Pharmaceuticals, 1-888- 838-2872.
February 2020
Class II
Fentanyl Citrate Inj 0409909412
Defective container
If you have questions about this recall, Pfizer Inc, 1-800-879-3477.
February 2020
Class II
Ethacrynate Sodium for Injection 06838224601
cGMP Deviations
If you have questions about this recall, Zydus Pharmaceuticals, 1-877- 993-8779.
February 2020
Class II
Caduet (amlodipine besylate/atorvastatin calcium) 00069218030
Defective container
If you have questions about this recall, Pfizer Inc, 1-800-879-3477.
February 2020
Class II
Hydrocortisone and Acetic Acid Otic 05038390110
Subpotent Drug
If you have questions about this recall, TECH PHARMACAL CO., INC, 1-800-932-5676.
February 2020
Class II
Ranitidine Hydrochloride 04306384414, 04306384430, 04306384490, 04306384401
cGMP Deviations
If you have questions about this recall, PD-Rx Pharmaceuticals, Inc., 1- 405-942-3040.
February 2020
Class II
Olmesartan Medoxomil Tablets 06787744690
cGMP Deviations
If you have questions about this recall, Ascend Laboratories LLC, 1-201- 476-1977.
February 2020
Class II
Atorvastatin Calcium Tablets 07037702711
Presence of Foreign Tablets
If you have questions about this recall, Graviti Pharmaceuticals Private Limited, 040 6815 5555.
February 2020
Class II
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10% 00363013711
Presence of Foreign Substance
If you have questions about this recall, Shandex Personal Care Manufacturing Inc., 1-613- 267-1881
February 2020
Class II
Nystatin Oral Suspension 00121081016
Subpotent
If you have questions about this recall, Pharmaceutical Associates Inc, 1-864- 277-7282.
February 2020
Class II
Ranitidine Tablets 70518171400
CGMP Deviation
If you have questions about this recall, RemedyRepack Inc, 1- 866-845-3791.
January 2020
Class II
Ranitidine Tablets 06878873883, 06878873889, 06878873881, 06878863821, 06878863823, 06878863829,
Trace amounts of an impurity
If you have questions about this recall, Preferred Pharmaceuticals, Inc, 1- 714-777-3729.
January 2020
Class II
06878863820
Nizatidine Capsules 00378515091, 00 378530093
Trace amounts of an impurity
If you have questions about this recall, Mylan Pharmaceuticals Inc, 1- 304-599-2595.
January 2020
Class II
Ranitidine Tablets 52959050207 52959050214 52959050220 52959050230 52959050260
Trace amounts of an impurity
If you have questions about this recall, H.J. Harkins Company, Inc, 1- 800-841-5554.
January 2020
Class II
Ranitidine Tablets 07093401704, 07093401720, 07093401724, 07093401730, 07093401790, 07093428715, 07093428790
Trace amounts of an impurity
If you have questions about this recall, Denton Pharma, Inc., 1-800-722- 0772.
January 2020
Class II
Netspot 06948800140
Defective container
If you have questions about this recall, Advanced Accelerator Applications USA, Inc., 1- 862-263-0820.
January 2020
Class II
Estriol USP Micronized 62991215906, 62991215903, 62991215905, 62991215902
Subpotent
If you have questions about this recall, Letco Medical LLC, 1-800-239- 5288.
January 2020
Class II
Dutasteride 5026828213
cGMP Deviations
If you have questions about this recall, AvKARE, Inc, 1-931-292-6222
January 2020
Class II
Testosterone Cypionate 06275601740,06275601540, 06275601640
cGMP Deviations
If you have questions about this recall, Sun Pharmaceutical Industries, Inc., 1-609-495-2800.
January 2020
Class II
Sumatriptan Succinate 06275652169, 06275652188
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
If you have questions about this recall, Sun Pharmaceutical Industries, Inc., 1-609-495-2800.
January 2020
Class II
Ranitidine 06255969060, 06255969005
Impurities
If you have questions about this recall, Appco Pharma LLC, 1-732-253- 7735.
January 2020
Class II
Ranitidine 03780819601,03780819604
Impurities
If you have questions about this recall, AAA Pharmaceutical, Inc, 1- 609-288-6060.
January 2020
Class II
Blisovi Fe 1.5/30 06818086611
Failed tablet
If you have questions about this recall, Lupin Pharmaceuticals Inc, 1- 410-576-2000.
January 2020
Class II
Estriol 07642004936,07642004937, 07642004938
Presence of impurities
If you have questions about this recall, Asclemed USA Inc, 1-310- 320-0100.
January 2020
Class II
Ranitidine 06846224860,68486224860, 06846224801, 68486224860, 06846224930, 68486224860, 06846224901, 68486224860, 06846224920, 68486224860, 06846224805, 68486224860
Presence of impurities
If you have questions about this recall, Glenmark Pharmaceuticals Inc, 1-888-721-7115
January 2020
Class II
Ranitidine 06220777332
Presence of impurities
If you have questions about this recall, Granules India Limited, 1-877-770- 3183.
January 2020
Class II
Myorisan® 0 6174830213
Unit dose mispackaging
If you have questions about this recall, Akorn, Inc, 1-800-932-5676.
January 2020
Class II
Ranitidine 06068726069
Presence of impurities
If you have questions about this recall, American Health Packaging, 1-800- 707-4621.
January 2020
Class II
Amantadine Hydrochloride 5974669901
Presence of foreign substance
If you have questions about this recall, Jubilant Cadista Pharmaceuticals, Inc. 1-410-860-8500
December 2019
Class II
25% Dextrose® 00409177510
Labeling error
If you have questions about this recall, Pfizer Inc1-877-225-9750
December 2019
Class II
Vancomycin Hydrochloride 05515020420
Product discoloration
If you have questions about this recall, AuroMedics Pharma LLC, 888-238-7880.
December 2019
Class II
Lidocaine Hcl 70004072309
Presence of foreign substance
If you have questions about this recall, SCA Pharmaceuticals, LLC, 1- 877-550-5059.
December 2019
Class II
Zantac® 06671597362, 06671597363,60671597368, 00597012201 00597012208, 00597012213 00597012237, 00597012240 00597012254, 00597012261 00597012281, 00597012296
Presence of impurities
If you have questions about this recall, Sanofi- Aventis U.S. LLC, 1- 800- 633-1610
December 2019
Class II
Regular Strength Zantac® 05026922225, 06775115101, 06775115201, 06775115202, 06815125840
Presence of impurities
If you have questions about this recall, Sanofi- Aventis U.S. LLC, 1- 800- 633-1610
December 2019
Class II
Maximum Strength Zantac® 00597012101, 00597012106, 00597012108, 00597012109, 00597012111, 00597012124, 00597012138, 00597012150, 00597012164, 00597012166, 00597012168, 00059701218, 00597012180, 00597012182, 00597012185, 00597012190, 0059701294
Presence of impurities
If you have questions about this recall, Sanofi- Aventis U.S. LLC, 1- 800- 633-1610
December 2019
Class II
Regular Strength Zantac® 04116703000, 04116703001, 04116703003, 04116703005, 04116703006, 04116703007, 04116703008,00526922025
Presence of impurities
If you have questions about this recall, Sanofi- Aventis U.S. LLC, 1- 800- 633-1610
December 2019
Class II
Cool Mint Tablets Maximum Strength Zantac® 00597012006,00597012008, 00597012009,00597012024, 00597012038,00597012050, 00597012076, 00597012078 00597012080,00597012082, 00597012087, 04116703201, 04116703202, 04116703203 04116703204,04116703205 04116703206, 04116703207
Presence of impurities
If you have questions about this recall, Sanofi- Aventis U.S. LLC, 1- 800- 633-1610
December 2019
Class II
Ibuprofen 068788726801
Presence of foreign substance
If you have questions about this recall, Preferred Pharmaceuticals Inc 1- 714-777-3729
December 2019
Class II
Lidocaine hcl 05515016505
Presence of foreign substance
If you have questions about this recall, AuroMedics Pharma, 1- 888-238-7880
December 2019
Class II
Ranitidine 04229172460, 04229172530,
Presence of impurities
If you have questions about this recall, AvKARE, Inc, 1-931-292-6222
December 2019
Class II
Ranitidine 06516225306, 06516225310, 06516225318, 06516225350, 06516225311, 06516225430, 06516225410, 06516225425, 06516266490, 05374625310, 05374625402
Presence of impurities
If you have questions about this recall, Amneal Pharmaceuticals, Inc., 1- 908-947-3120
December 2019
Class II
Ranitidine 068788707803, 068788707806
Presence of impurities
If you have questions about this recall, Preferred Pharmaceuticals Inc 1- 714-777-3729
December 2019
Class II
Ranitidine 05591009279
Presence of impurities
If you have questions about this recall, Dolgencorp LLC, Inc, 1- 615-855-4000
December 2019
Class II
Ranitidine 05965114460, 059651145-30, 06586243174, 05965114405,
Presence of impurities
If you have questions about this recall, Aurobindo Pharma, 1-866- 850-2876
December 2019
Class II
Walgreens Sodium Chloride Ophthalmic Solution 00363019313
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Walgreens Sodium Chloride Ophthalmic Ointment 00363750050
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Walgreen’s Lubricant Eye Ointment, Mineral Oil 00363019150
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Equate Support Harmony Lubricant Eye Drops 04903514510
Lack of Assurance of Sterility
If you have questions about this recall, Altaire
November 2019
Class II
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
Equate Support Advanced 04903588549
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Equate Support Advanced Lubricating Eye Drops 04903588254
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Equate Support Advanced Lubricant Gel Drops 0903588252
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Equate Sterile Lubricant Stye Ointment 04903587550
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Equate Restore Tears Lubricant Eye Drops Twin Pack 04903518949
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Equate Restore PM Nighttime Lubricant Eye Ointment 04903519150
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Equate Night & Day Restore Tears Lubricant Eye Pack 04903588359
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Equate Eye Allergy Relief Drops 4903587413
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Equate Eye Allergy Relief Drops 04903588713
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Equate Comfort Gel Lubricant Eye Gel 04903519749
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Puralube Petrolatum Ophthalmic Ointment® 00574402535
Lack of Assurance of Sterility
If you have questions about this recall, Altaire
November 2019
Class II
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
Polycin (bacitracin zinc and polymyxin B sulfate) Ophthalmic Ointment® 00574402135
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Tetcaine (Tetracaine Hydrochloride) Ophthalmic Solution® 05479950215
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
CVS Health Preservative Free Lubricant Eye Drops® 50428302958
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
TRP Stye Relief® 01731201413
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
TRP Pink Eye Relief® 01731201315
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
TRP Blur Relief 01731200211
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Perrigo Sulfacetamide Sodium Ophthalmic Ointment® 00574419035
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Perrigo Sterile Neo-Polycin HC (neomycin and polymixin B sulfates, bacitracin zinc and hydrocortisone acetate) Ophthalmic® 00574414435
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Perrigo Neo-Polycin neomycin and polymixin B sulfates and bacitracin zinc Ophthalmic Ointment® 0574425035
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Perrigo Neomycin and Polymixin B Sulfates and Dexamethasone Ophthalmic® 0574416035
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Perrigo Bacitracin Ophthalmic Ointment® 0574402235
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Ofloxacin Ophthalmic Solution 05939014005
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic® 05479950505
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
OCuSOFT Tetravisc Tetracaine HCl 0.5% Sterile Anesthetic 05479950501®
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
OCuSOFT Tetravisc Forte Tetracaine HCl 0.5 % Sterile Anesthetic® 05479950405
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
OCuSOFT Tetravisc Forte (Tetracaine HCl) 0.5% Sterile Anesthetic®
Lack of Assurance of Sterility
If you have questions about this recall, Altaire
November 2019
Class II
05479950401
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
OCuSOFT Tears Again Sterile Lubricant Eye Drops® 05479990430
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Ocusoft Tears Again Lubricant Eye Drops ® 05479990415
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
OCuSOFT Homatropine Hydrobromide Ophthalmic Solution® 05479943105
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Ocusoft Goniosoft Hypromellose 2.5% Opthalmic Demulcent Solution® 05479950315
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
OCuSOFT Flucaine Proparacaine Hydrochloride and Fluorescein Sodium Ophthalmic Solution® 05479950721
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
OCuSOFT Eye Wash Sterile Isotonic Buffered Solution® 05479956501
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
OCuSOFT Eye Wash Sterile Isotonic 05479956559
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Natural Ophthalmics Women’s Tear Stimulation Dry Eye Drops® 06877010315
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Natural Ophthalmics Tear Stimulation Forte Dry Eye Drops® 06877010415
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Natural Ophthalmics Ortho-K Thin Eye Drops® 06877014415
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Natural Ophthalmics Ortho-K Thick Comfort Gel 06877014315
Lack of Assurance of Sterility
If you have questions about this recall, Altaire
November 2019
Class II
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
Natural Ophthalmics Cataract Eye Drops® 06877013015
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Natural Ophthalmics Allergy Desensitization Eye Drops® 06877012015
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Nano Tears XP Clear Emollient Lubricant Gel Drops® 05939014351
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Nano Tears TF Clear Emollient Lubricant Gel Drops® 05939014249
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Nano Tears TF Clear Emollient Lubricant Gel Drops® 05939014156
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Lubricant Eye Drops Moisturizing Twin Pack® 00363018549
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
iSolutions NanoTears HA Preservative Free Multi – Dose Lubricant Gel Drops® 05939020810
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
iSolutions Nano Tears XP Clear Emollient Lubricant Gel Drops® 05939014310
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops® 05939014213
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
iSolutions Nano Tears TF Clear Emollient Lubricant Gel Drops® 05939014152
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops®
Lack of Assurance of Sterility
If you have questions about this recall, Altaire
November 2019
Class II
05939014756
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
iSolutions Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops® 05939014410
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
iSolutions Nano Tears MO Clear Emollient Lubricant Drops® 05939014510
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
iSolutions ActivEyes Nighttime Lubricant Eye Ointment® 05939019050
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
FreshKote Lubricant Eye Drops® 01582110115
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Altaire Sterile Eye Wash® 05939017513, 05939017535, 05939017518
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Altaire Homatropaire Homatropine Hyrdobromide Opthalmic Solution® 05939019205
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution® 05939018213
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Altaire Fluorescein Sodium with Proparacaine Hydrochloride Ophthalmic Solution 05939020505®
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Altaire Diclofenac Sodium Opthalmic Solution® 5939014905
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Altaire Diclofenac Sodium Opthalmic Solution® 05939014902
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Altaire Ciprofloxacin Ophthalmic Solution® 05939021710
Lack of Assurance of Sterility
If you have questions about this recall, Altaire
November 2019
Class II
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
Altaire Ciprofloxacin Ophthalmic Solution® 05939021702
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Altaire Ciprofloxacin HCl Ophthalmic Solution® 05939021705
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Altacaine (Tetracaine Hydrochloride) Ophthalmic Solution ® 05939018113
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
ActivEyes Sterile Altalube Ointment® 05939019850
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops® 05939014852
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
ActivEyes Preservative Free Multi-Dose Lubricant Drops® 05939014652
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
ActivEyes Sterile Altalube Ointment® 05939019850
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
ActivEyes Preservative Free Multi-Dose Lubricant Gel Drops® 05939014852
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
ActivEyes Preservative Free Multi-Dose Lubricant Drops® 05939014652
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
ActivEyes Lubricant Eye Ointment® 05939018950
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
ActivEyes Altachlore Solution 05939018313®
Lack of Assurance of Sterility
If you have questions about this recall, Altaire
November 2019
Class II
Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
ActivEyes Altachlore Sodium Chloride Hypertonicity Opthalmic Ointment® 05939018450
Lack of Assurance of Sterility
If you have questions about this recall, Altaire Pharmaceuticals, Inc, 1- 631-722-5988 Ext 16
November 2019
Class II
Ranitidine 05140709705
impurity detected
If you have questions about this recall, Golden State Medical Supply Inc. 1-805-477-9866
November 2019
Class II
Novitium Pharma Ranitidine® 07095400120 07095400140 07095400210 07095400240
impurity detected
If you have questions about this recall, Novitium Pharma LLC. 1-855-204- 1431
November 2019
Class II
Rite Aid Pharmacy Maximum Strength Ranitidine ® 01182260522 01182260518
Possible contamination
If you have questions about this recall, Apotex Inc. 1-800-706-5575
November 2019
Class II
Equate Maximum Strength Ranitidine® 04903511706
Possible contamination
If you have questions about this recall, Apotex Inc. 1-800-706-5575
November 2019
Class II
Rite Aid Pharmacy Maximum Strength Ranitidine® 01182261074
Possible contamination
If you have questions about this recall, Apotex Inc. 1-800-706-5575
November 2019
Class II
Equate Maximum Strength Ranitidine® 04903510007 04903510000
Possible contamination
If you have questions about this recall, Apotex Inc. 1-800-706-5575
November 2019
Class II
Walgreens Regular Strength Wal-Zan 75 Ranitidine® 00363102903
Possible contamination
If you have questions about this recall, Apotex Inc. 1-800-706-5575
November 2019
Class II
Walgreens Maximum Strength Wal-Zan 150 Ranitidine® 00363103007 00363103006
Possible contamination
If you have questions about this recall, Apotex Inc. 1-800-706-5575
November 2019
Class II
Alprazolam tablets 00378400305
Presence of foreign substance
If you have questions about this recall, Mylan Pharmaceuticals. 1-304- 599-2595
November 2019
Class II
Ranitidine tablets 00363001061 ,00363001062 ,00363001001, 04903540461, 04903540413,04903540465, 03014250534, 03014250550, 00150062076, 06984287130, 06984287180,06984287137,
Impurity detected in product.
If you have questions about this recall, Dr. Reddy’s Laboratories, Inc. 1-309-375-9900
November 2019
Class II
03014213130, 06386848230, 06386848260, 04359880862 04359880865, 07171320302 07171320305, 05789671524, 01167384940, 05511113160, 05511140434, 00363013130 00363013180, 06386848024 06386848050, 05789671705
Ranitidine capsules 05511112960, 05511112905, 05511113030, 05511113001
Impurity detected in product.
If you have questions about this recall, Dr. Reddy’s Laboratories, Inc. 1-309-375-9900
November 2019
Class II
Atorvastatin calcium 06050525808
Presence of foreign substance
If you have questions about this recall, Apotex, Inc. 1-800-706-5575
November 2019
Class II
Gatifloxacin Ophthalmic Solution® 06131467225
Labeling error
If you have questions about this recall, Sandoz, Inc. 1-609-627-8500
November 2019
Class II
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension 06131463006
Incorrect or missing package insert
If you have questions about this recall, Sandoz, Inc. 1-609-627-8500
November 2019
Class II
Bimatoprost Ophthalmic Solution 00781620675
Incorrect or missing package insert
If you have questions about this recall, Sandoz, Inc. 1-609-627-8500
November 2019
Class II
Testosterone Cypionate Injection 05253662501
Labeling error
If you have questions about this recall, Arbor Pharmaceuticals. 1-866- 284-8792
November 2019
Class II
Ranitidine tablets 05591009279
Empty bottles
If you have questions about this recall, AuroMedeics Pharma LLC.
November 2019
Class II
Ranitidine hydrochloride capsules 04229173550,04229173650
Impurities
If you have questions about this recall, AvKare, Inc. 1-931-292-6222
November 2019
Class II
Estradiol vaginal inserts 06846271188
Impurities
If you have questions about this recall, Glenmark Pharmaceuticals. 1-888- 721-7115
November 2019
Class II
Prasugrel tablets® 00378518593
Failed dissolution specification
If you have questions about this recall, Mylan Pharmaceuticals. 1-304- 599-2595
November 2019
Class II
Ibuprofen suspension 05167213858,05167221308, 51672138509,05167221301, 6709132104
Presence of foreign substance
If you have questions about this recall, Taro Pharmaceuticals. 1-866- 923-4914
November 2019
Class II
Leucovorin Calcium 05074246450
Presence of particulate matter
If you have questions about this recall, Ingenus Pharmaceutical. 1-877- 748-1970
October 2019
Class II
Pioglitazone Hydrochloride 03334205407
Superpotent
If you have questions about this recall, Macleods Pharmaceuticals Ltd, 91- 22-6676-2800
October 2019
Class II
Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate 01310707301
Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness.
If you have questions about this recall, Aurobindo Pharma USA Inc. 1-732-839-9400
October 2019
Class II
Fentanyl Citrate® 49452003206
Potential contamination
If you have questions about this recall, Spectrum Laboratory Products. 1- 800-772-8786
October 2019
Class II
Ascorbic Acid 07159150050
Labeling issue
If you have questions about this recall, Atlas
October 2019
Class II
Pharmaceutical. 1-410- 860-8500
Pantoprazole Sodium Delayed Release 05974628490
Discoloration on edges of tablets
If you have questions about this recall, Jubilant Cadista Pharmaceuticals, Inc. 1-410-860-8500
October 2019
Class II
Vivitrol® 65757030001
Mislabeling
If you have questions about this recall, Alkermes, Inc. 1-800-848-4876
September 2019
Class II
Relpax® 00049234005, 00049234045
Microbial contamination
If you have questions about this recall, Pfizer Inc1-877-225-9750
September 2019
Class II
Hydrocortisone cream with aloe, Hydrocortisone 00363062003, 00363062004
Potential microbial contamination
If you have questions about this recall, US Pharmaceuticals Inc. 1- 888-337-7464
August 2019
Class II
Lisinopril and hydrochlorothiazide tablets 68180051801, 68180051802
Brownish/blackish stains on the tablets
If you have questions about this recall, Lupin Limited 1-866-587-4617
August 2019
Class II
Nitrofurantoin monohydrate/macrocrystals capsules 47781030301
Failed dissolution specifications
If you have questions about this recall, Alvogen, Inc. 1-866-770-3024
August 2019
Class II
Macrobid Urinary Tract Antibacterial 52427028501
Failed dissolution specifications
If you have questions about this recall, Alvogen, Inc. 1-866-770-3024
August 2019
Class II
Aspirin and extended-release dipyridamole capsules 60687030532
Failed impurities/degradation specifications
If you have questions about this recall, American Health Packaging 1-614- 492-8177
August 2019
Class II
Doxycycline hyclate 62584069321
Failed dissolution specifications
If you have questions about this recall, American Health Packaging
August 2019
Class II
Neomycin 3.5 mg/g / polymyxin b10000 usp units/g / dexamethasone 1 mg/g ophthalmic ointment 52959040701
Insufficient quality
If you have questions about this recall, H.J. Harkins Company 1-805- 929-1333
July 2019
Class II
Diphenhydramine 49035033002, 49035033096, 49035033045
Contamination
If you have questions about this recall, LNK International 1-631-543- 3787
July 2019
Class II
Norethindrone and ethinyl estradiol 68180090313
Failed Impurities
If you have questions about this recall, Lupin Pharmaceuticals 1-800- 399-2561
July 2019
Class II
Milrinone lactate 00409277602, 00409277623
Bags have the potential to leak
If you have questions about this recall, Pfizer Inc. 1-800-879-3477
July 2019
Class II
Fluorouracil injection 63323011710, 63323011719, 63323011728, 63323011761, 63323011761, 63323011769, 63323011718, 63323011720, 63323011751, 63323011759, 63323011768
Glass Particles
If you have questions about this recall, Fresenius Kabi 1-888-386-1300
June 2019
Class I
Heparin Sodium® 00264958720
Not potent
If you have questions about this recall, Braun Medical Inc 1-800-523- 9676
June 2019
Class II
Estradiol vaginal inserts 68462071171, 68462071188
Defective delivery
If you have questions about this recall, Glenmark Pharmaceuticals Inc 1-201-684-8000
June 2019
Class II
Zyflo Cr® 10122090212, 10122090220
Failed dissolution
If you have questions about this recall, Chiesi USA, 1-919-678-6611
June 2019
Class II
Pramipexole dihydrochloride 68084079325, 68084097425
Possible cross contamination
If you have questions about this recall, American Health Packaging, 1-800- 707-4621
May 2019
Class II
Zileuton® 66993048532
Failed dissolution
If you have questions about this recall, Chiesi USA, 1-919-678-6611
May 2019
Class II
Testosterone 69699170230, 69699170210
Lack of sterility
If you have questions about this recall, Pharm D. Solutions 1-713-790-1693
May 2019
Class II
Hydrocodone bitartrate and homatropine methylbromide oral solution 59741026216, 13668057710
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Risperidone 23155031751
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Cetirizine hydrochloride 23155029251, 23155029252, 13668059607, 13668059611
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Phenylephrine hydrochloride 00536138912, 00536138935, 00904768822
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Bisacodyl 00536135501, 00536135512
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Hydrocortisone acetate suppositories 59741030101, 59741030124, 59741030112
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Memantine hydrochloride 39328055112 13668057309
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Lactulose solution
Contamination with burkholderia
If you have questions about this recall, Torrent
May 2019
Class II
13668058008, 13668058012, 13668057408, 13668057412, 13668057410
Pharma Inc 1-800-912- 9561
Pseudoephedrine Hydrochloride 00536185085, 00536185097
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Diphenhydramine hydrochloride 00536077085, 00536077097
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Guaifenesin & dextromethorphan hydrobromide 00536097085, 00536097097
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Guaifenesin 00536082585, 00536082597
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Acetaminophen 00536012285, 00536012297
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Phenobarbital 16571033016
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Guaifenesin, Codeine Phosphate & Pseudoephedrine Hydrochloride 16571030116
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Guaifenesin AC 16571030216
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Acetic Acid 64980042415
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Hyoscyamine sulfate 39328004715, 39328004816
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Cyproheptadine hydrochloride 39328004416
Contamination with burkholderia
If you have questions about this recall, Torrent
May 2019
Class II
Pharma Inc 1-800-912- 9561
Bisacodyl 00904505812, 00904505860
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Pedia Relief 00904505020
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Robafen dm cough sugar free clear 00904630620
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Oxymetazoline Hydrochloride 00904571130, 00904571135
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Pseudoephedrine hydrochloride 00536185085, 00536185097
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Banofen 904517416
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Robafen DM 00904005300, 00904005316 00904005309
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Robafen AC 00904647916
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Risperidone 13668058906
Contamination with burkholderia
If you have questions about this recall, Torrent Pharma Inc 1-800-912- 9561
May 2019
Class II
Pecgen dmx 52083063016
Incorrect labeling instructions
If you have questions about this recall, Novis PR 1-800-727-6711
May 2019
Class I
Cefdinir for oral suspension 68180072310, 68180072320
Metal piece identified in the product bottle
If you have questions about this recall, Lupin
May 2019
Class II
Pharmaceuticals Inc 1- 410-576-2000
Articaine Hydrochloride and Epinephrine Bitartrate® 66312060116
Mislabeling
If you have questions about this recall, Septodont Inc 1-717-286- 0100
May 2019
Class II
Losartan Potassium tablets 23155064503, 23155064509, 23155064510, 23155064603, 23155064610, 23155064609, 23155064403, 23155064410, 23155064409
Presence of an impurity
If you have questions about this recall, Heritage Pharmaceuticals Inc 1- 866-901-DRUG (3784)
May 2019
Class II
Amitiza® 64764008060, 64764024010, 64764024060
24 mcg capsules were found in a 8 mcg
If you have questions about this recall, Mallinckrodt Pharmaceuticals 1-314- 654-2000
May 2019
Class II
Losartan Potassium tablets 60429031610, 60429031690, 60429031630, 60429031810, 60429031890, 60429031830
Presence of an impurity
If you have questions about this recall, Golden State Medical Supply Inc 1-800-284-8633 ext. 215
May 2019
Class II
Divalproex sodium 00904636345, 00904636361
Exposed above 50% relative humidity levels
If you have questions about this recall, Major
April 2019
Class II
Pharmaceuticals 1-800- 875-0123 option 5
Losartan Potassium tab 68788004809
Presence of an impurity
If you have questions about this recall, Preferred Pharmaceuticals Inc 1- 714-777-3729
April 2019
Class II
Carvedilol tablets 65841061605
Label Mix-up
If you have questions about this recall, Zydus Pharmaceuticals 1-877- 993-8779
April 2019
Class II
Ketorolac tromethamine 25021070101, 25021070102
Lack of sterility
If you have questions about this recall, Sagent Pharmaceuticals 1-866- 625-1618
April 2019
Class II
Acyclovir tablets 68382079101, 68382079106, 68382079116, 68382079105, 68382079110, 68382079130
Label mix-up
If you have questions about this recall, Zydus Pharmaceuticals 1-877- 993-8779
April 2019
Class II
Fentanyl transdermal system, 12 mcg/h 47781042347
Label mix-up
If you have questions about this recall, Alvogen 1-866-770-3024
April 2019
Class I
Losartan Potassium/hctz 70518156000
Presence of an impurity
If you have questions about this recall, Remedy Repack 1-866-845-3791
April 2019
Class II
Losartan Potassium and hydrochlorothiazide tablets 13668011610, 13668011674, 13668011630, 13668011690, 13668011710, 13668011774, 13668011730, 13668011790, 13668011810, 13668011874, 13668011830, 13668011890
Presence of an impurity
If you have questions about this recall, Torrent Pharmaceuticals 1-800- 912-9561
April 2019
Class II
Losartan Potassium 68645049454
Presence of an impurity
If you have questions about this recall, Legacy Pharmaceutical Packaging LLC 1-314-813-1555
April 2019
Class II
Losartan Potassium 50268051715, 50268051615
Presence of an impurity
If you have questions about this recall, Avkare Inc 1-931-292-6222
April 2019
Class !!
Losartan Potassium 13668011310, 13668011390, 13668011374, 13668040990, 13668040930, 13668040910, 13668040974, 13668011510, 13668011574, 13668011530, 13668011590
Presence of an impurity
If you have questions about this recall, Torrent Pharmaceuticals 1-800- 912-9561
April 2019
Class II
Gavilyte- N 43386-0050-19
Labeling incorrectly classified
If you have questions about this recall, Lupin Pharmaceuticals 1-800- 399-2561
March 2019
Class II
Combigan 00023921103, 00023921110, 00023921105, 00023921115
Trace amounts of an impurity
If you have questions about this recall, Ecolab 1- 800-433-8871
March 2019
Class II
Pravastatin Sodium 68462-0196-05, 68462-0196-90
Foreign tablet in bottle
If you have questions about this recall, Glenmark Pharmaceuticals, Inc. 201- 684-8000
March 2019
Class II
Losartan 70518-0588-01
Trace amounts of impurity
If you have questions about this recall, Remedy repack Inc 1-886-845- 3791
March 2019
Class II
Phenobarbital 70166-0536-02
The label contains the incorrect expiration date
If you have questions about this recall, Lohxa LLC 1-800-641-5564
March 2019
Class II
Losartan Potassium 31722-0702-30
Impurity found
If you have questions about this recall, Pharma Pac 1-805-929-1333
March 2019
Class II
Volumex 50914-7720-08
Lack of assurance
If you have questions about this recall, Iso-Tex Diagnostics 1-800-477- 4539
March 2019
Class II
Hydrocortisone and Acetic Acid 50383-0301-10
Sub Potent Drug
If you have questions about this recall, call Akon Inc. 1-800-477-4539
March 2019
Class II
Losartan Potassium 68645-0578-54
Trace amounts of impurity
If you have questions about this recall, Call Legacy 1-877-538-8443
February 2019
Class II
Losartan Potassium/Hydrochlorothiazide 13668-0118-10, 13668-0118-74, 13668-0118-30,13668-0118-90, 13668-0117-10, 13668-0117-74, 13668-0117-30, 13668-0117-90, 13668-0116-10, 13668-0116-74, 13668-0116-30, 13668-0116-90
Presence of Impurity
If you have questions about this recall, Call Torrent Pharmaceuticals 1-800-912-9561
February 2019
Class II
Losartan Potassium 13668-0113-10, 13668-0113-90, 13668-0113-74 13668-0409-10
Presence of an impurity
If you have questions about this recall, Call
February 2019
Class II
13668-0409-74, 13668-0409-30, 13668-0409-90, 13668-0115-10, 13668-0115-74, 13668-0115-30, 13668-0115-90
Torrent Pharmaceuticals 1-800-912-9561
Valsartan 52343-0122-30, 52343-0123-90, 52343-0124-90, 52343-0125-90
Presence of an impurity
If you have questions about this recall, Call Preferred Pharmaceuticals 1-855-544-9419
February 2019
Class II
Losartan Potassium 68788-6882-03, 68788-6882-09
Presence of an impurity
If you have questions about this recall, Call Preferred Pharmaceuticals 1-855-544-9419
February 2019
Class II
Valsartan 60687-0139-01
Trace amounts of an impurity
If you have questions about this recall, call Aurobindo 1-800-912- 9572
February 2019
Class II
Losartan Potassium 31722-0702-05, 31722-0702-30, 31722-0702-90, 31722-0702-10, 31722-0702-60, 50268-0517-15, 50268-0513-15, 50268-0514-15, 68645-0577-54
Trace amounts of an impurity
If you have questions about this recall, call Aurobindo 1-800-912- 9572
February 2019
Class II
Alprazolam 51079-0788-20
Failed impurities/degradation
If you have questions about this recall, call Mylan 1-888-406-9305
January 2019
Class II
Ceftriaxone for Injection 68180-0611-01
Presence of Particulate Matter: Product complaints received of grey flecks, identified as shredded rubber particulate matter from the stopper observed in reconstituted vials
If you have questions about this recall, Lupin Pharmaceuticals Inc. 111 S Calvert St Fl 21ST Baltimore, MD 21202-6174
January 2019
Class I
Vecuronium Bromide for Injection 10 mg 47335-0931-44
Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromide for Injection.
If you have questions about this recall, Sun Pharmaceutical Industries, Inc. 270 Prospect Plains Rd Cranbury, NJ 08512-3605
January 2019
Class I
OZURDEX 0023-3348-07
Deviations: A silicone particulate was noted in Ozurdex
If you have questions about this recall, Allergan, PLC. 5 Giralda Farms Madison, NJ 07940-1027 (714) 246-4500
January 2019
Class II
Estradiol Vaginal Inserts 68462- 711-71 68462-711-88
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
If you have questions about this recall, Glenmark Pharmaceuticals Inc., USA
January 2019
Class II
750 Corporate Dr Mahwah, NJ 07430-2009
Dianeal Low Calcium 00941-0424-52 Lot #: Y281477 Expiration: 02/2020
Lack of Assurance of Sterility: Confirmed customer complaints for leaks on the tubing
If you have questions about this recall, Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625
January 2019
Class II
Cefdinir for Oral Suspension USP 125mg/5mL 68180-0722-10 68180-0722-20
Deviations: Product complaints received indicating reconstituted suspension was observed to be thick
If you have questions about this recall, Lupin Pharmaceuticals Inc. 111 S Calvert St Fl 21ST Baltimore, MD 21202- 6174 866-587-4617
January 2019
Class II
Cidofovir Injection 375mg 23255-0216-31
Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
If you have questions about this recall, Heritage Pharmaceuticals, Inc. 1 Tower Center Blvd Ste 1700 East Brunswick, NJ 08816-1145 732) 429-1000
January 2019
Class II
Cephalexin for Oral Suspension USP 68180-0124-01
Deviation; manufacturing batch record could not be located
If you have questions about this recall, Lupin Pharmaceuticals Inc.
January 2019
Class II
68180-0124-02
111 S Calvert St Fl 21ST Baltimore, MD 21202 866-587-4617
Valsartan tablets USP 320 mg 65862-0573-05 65862-0573-90
Deviations: FDA lab confirmed presence an impurity, N- nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
If you have questions about this recall, Aurobindo Pharma USA Inc. 279 Princeton Hightstown Rd East Windsor, NJ 08520- 1401 732-839-9400
January 2019
Class II
Valsartan and Hydrochlorothiazide tablets 65862-0549-10 65862-0549-90 65862-0549-99
Deviations: FDA lab confirmed presence an impurity, N- nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million
If you have questions about this recall, Aurobindo Pharma USA Inc. 279 Princeton Hightstown Rd East Windsor, NJ 08520 732- 839-9400
January 2019
Class II
Amlodipine and Valsartan Tablets USP 10 mg/320 mg
Deviations: FDA lab confirmed presence an impurity N-
If you have questions about this recall
January 2019
Class II
65862-0740-03 65862-0740-30 65862-0740-90
nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Aurobindo Pharma USA Inc. 279 Princeton Hightstown Rd East Windsor, NJ 08520- 1401 732 839 9400
EEMT (esterified estrogens and methyltestosterone 15310-0010-01
The combination of esterified estrogens and methyltestosterone is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation.
If you have questions about this recall, Syntho Pharmaceuticals, Inc. 230 Sherwood Ave Farmingdale, NY 11735- 1718 631-755-9898
January 2019
Class II
Olmesartan Medoxomil and Hydrochlorothiazide Tablets, 40 mg/25 mg 00093761756 00093761798
Failed dissolution specifications
If you have questions about this recall, Teva Pharmaceuticals USA 1090 Horsham Rd North Wales, PA 19454- 1505 888-TEVA-USA (888-838- 2872)
January 2019
Class II
Fluocinolone Acetonide Topical Solution, USP, 0.01 %, 60 mL bottle Lot #: S700214, Exp Apr-19; S700447, Exp Jun-19; S700787, Exp Oct-19; S701057, Exp Nov- 19; S800107, Exp Feb-20; S800266, Exp Mar-20; S800524, Exp May-20; S800791 Kul Exp Jul-20
Failed Impurities/Degradation Specifications: Expansion of October 2018 recall due to elevated out of specification results for total impurities that have been chemically identified as oxidative degradation products of the fluocinolone active pharmaceutical ingredient
If you have questions about this recall, Contact: LUPIN SOMERSET 400 Campus Dr Somerset, NJ 08873-1145
January 2019
Class II
Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles Lot #: 43E021 and 43E023, Exp. 01/2020
Presence of Foreign Substance: Product complaint of black speckles observed on tablets.
If you have questions about this recall, Contact: Dr. Reddy’s Laboratories, Inc. 107 College Rd E Princeton, NJ 08540-6623
January 2019
Class II
Losartan potassium and hydrochlorothiazide 1000mg/25mg tablets ONLY Lot: JB8912
This product is being recalled due to th presence of an impurity, N- nitrosodiethylamine. NDEA occurs naturally in manufacturing processes and could cause cancer based on laboratory test results. No adverse effects related to this recall have been reported to date.
If you have questions about this recall, Contact Sandoz Inc. at 1-800-525- 8747 Monday-Friday 8:30 AM – 5:00 PM (EST) or email usdrugsafety.operations@ novartis.com.
November 2018
Class I
Montelukast Sodium 10Mg
This medicine is made by Camber Pharmaceuticals, Inc. This medicine is being recalled because sealed bottles labeled as Montelukast sodium tablets, 10 mg, 30-count bottle from Camber were found to instead contain 90 tablets of losartan potassium tablets, 50 mg. This could result in a life-threatening condition.
If you have questions about this recall, call Camber Pharmaceuticals Med Line at 1-866-495- 1995
September 2018
Class I
Diphenoxylate Hydrochloride and Atropine Sulfate tablets, 2.5 mg/0.025 mg (Lomotil).
This medication is made by Greenstone LLC, a wholly owned subsidiary of Pfizer, Inc. This medication is being recalled due to super potency. The use of the impacted super potent product when used as labeled has a low probability of being associated with adverse events of limited severity such as lethargy, skin flush, and drowsiness. Serious adverse events such as coma and respiratory depression are improbable.
If you have questions about this recall, please contact Pfizer Customer Support at 800-879-3477.
January 2018
Class I
EpiPen and EpiPen Jr Auto- Injector
This medication is made by Mylan. This medication is being recalled due to failure to activate the device or increased force needed to activate due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency. This could result in a life-threatening condition.
If you have questions about this recall, please contact your physician, pharmacy or Mylan Customer Relations at 800-796-9526 or customer.service@mylan. com.
May 2017
Class I