AvKARE, LLC. Issues Voluntary Nationwide Recall of Atovaquone Oral Suspension Due to Potential Contamination: What Consumers Need to Know

AvKARE, LLC has initiated a voluntary recall of Atovaquone Oral Suspension, USP 750 mg/5 mL, lot # AW0221A, due to potential Bacillus cereus contamination. This recall was prompted by findings during stability testing at a third-party laboratory.

The affected product, Atovaquone Oral Suspension, USP, is used for the prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children aged 13 years and older who are unable to tolerate other medications such as trimethoprim-sulfamethoxazole. The recall pertains specifically to lot # AW0221A, which was distributed nationwide to wholesalers between March 18, 2024, and March 21, 2024.

Bacillus cereus contamination poses a significant risk, especially to immunocompromised individuals, potentially leading to severe, life-threatening infections like endocarditis and necrotizing soft tissue infections. As of now, AvKARE has not received any reports of adverse events related to this recall.

Consumers and healthcare providers are advised to discontinue use of the affected product and return it to the place of purchase or discard it. AvKARE is actively notifying distributors and wholesale customers and facilitating the return of the recalled product. Wholesalers in possession of the affected lots are instructed to cease dispensing and return the product to AvKARE.

Consumers with questions regarding the recall can contact AvKARE by phone at 1-855-361-3993 or via email at drugsafety@avkare.com, Monday through Friday, from 9 am to 5 pm Eastern Time. Adverse reactions or quality problems associated with the use of this product should be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

This recall is being conducted in coordination with the U.S. Food and Drug Administration (FDA).

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