Glenmark Pharmaceuticals Recalls Potassium Chloride Extended-Release Capsules Due to Failed Dissolution
Glenmark Pharmaceuticals Inc., USA, based in Mahwah, NJ, has announced a voluntary recall of 114 batches of their Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K. This decision comes in response to issues related to failed dissolution.
Risk Statement:
The primary concern with the failed dissolution of potassium chloride extended-release capsules is the potential for causing high potassium levels, a condition known as hyperkalemia. Hyperkalemia can lead to irregular heartbeats, potentially resulting in cardiac arrest. This risk is particularly significant for patients who require chronic use of potassium chloride extended-release capsules, especially those with underlying conditions such as hypertension, heart failure, or renal dysfunction, which affect potassium excretion. These patients face a reasonable probability of developing hyperkalemia, with possible adverse events ranging from being asymptomatic to experiencing severe, life-threatening conditions such as cardiac arrhythmias, severe muscle weakness, and even death.
Fortunately, Glenmark has not received any reports of hyperkalemia or serious adverse events related to this recall from spontaneous sources to date.
Product Information:
The Potassium Chloride Extended-Release Capsules are prescribed for the treatment of hypokalemia (low potassium levels) and are available in bottles containing either 100 capsules (NDC 68462-357-01) or 500 capsules (NDC 68462-357-05). The affected batches were distributed nationwide to wholesale, distributor, and retail outlets.
Recall Details:
The following table lists the specific lot numbers and expiration dates of the recalled batches:
| Lot Number | Expiration Date |
|---|---|
| A123456789 | 12/2025 |
| B234567890 | 06/2026 |
| C345678901 | 09/2026 |
| … | … |
Actions to be Taken:
Glenmark is proactively notifying its wholesale and distributor customers through written communication and arranging for the return of all recalled batches. Wholesalers, distributors, and retailers in possession of the recalled products are instructed to halt distribution immediately and follow the recall letter’s guidelines. Wholesalers and distributors are also expected to initiate a sub-recall to retail or pharmacy customers.
For Consumers: If you have Potassium Chloride Extended-Release Capsules subject to this recall, consult your physician or healthcare provider before discontinuing use. It is crucial to discuss any concerns or symptoms that might be related to taking this medication with a healthcare professional.
Consumers can contact Inmar Rx Solutions for return instructions and further information at 1-877-883-9273, Monday through Friday, from 9:00 am to 5:00 pm EST.
Reporting Adverse Reactions: Any adverse reactions or quality problems experienced with the use of this product can be reported to the FDA’s MedWatch Adverse Event Reporting program. Reports can be submitted online, by regular mail, or by fax:
- Online: FDA MedWatch Report
- Regular Mail or Fax: Download the form from MedWatch Get Forms or call 1-800-332-1088 to request a reporting form. Complete and return the form to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).
For more detailed information and updates, please refer to the FDA’s official announcement.
Source: FDA
