Atovaquone Oral Suspension Recall Issued Due to Bacterial Contamination Risks

Bionpharma is instructing customers with the recalled antibiotic to immediately return the contaminated products to prevent the risk of severe infection.

A batch of the pneumonia antibiotic drug Atovaquone has been recalled, after the manufacturer found the medication may be contaminated with a bacteria that can result in life threatening infections.

The U.S. Food and Drug Administration (FDA) announced the Atovaquone Oral Suspension recall on September 17, 2024, warning customers to immediately stop using the recalled medication after discovering it may contain Cohnella bacteria.

Atovaquone is a prescribed, antimicrobial drug used for the prevention of pneumocystis jirovecii pneumonia (formerly known as PCP) in individuals aged 13 or older.

Although Bionpharma, the manufacturer, has not received any reports of adverse events related to the contamination, the presence of Cohnella bacteria could result in serious infections, such as heart inflammation and permanent soft tissue damage. The recall notice warns that immunocompromised individuals are most at risk.

The recall specifically includes Atovaquone Oral Suspension (750mg/mL) with lot number 2310083, NDC number 69452-252-87, and expiration of September 2025. The affected batch was shipped to customers nationwide, and distributed through wholesalers and retailers between December 21, 2023 and June 20, 2024.

Potentially affected products can be identified by their white bottles, with the lot number printed on either the side panel or bottom flap of the carton.

The company indicates it is notifying its distributors and customers by email and is arranging for the return/replacement of the recalled product. Consumers with the affected product are advised to stop using the product and return it to the place of purchase.

Retailers with the affected drug are instructed to immediately stop distributing the product and remove it from active inventory.

Customers are advised to contact their physician or healthcare provider if they experience any problems that may be related to using the affected lot of the drug product. Adverse reactions or quality problems experienced with the use of the product may be reported to the FDA’s MedWatch Adverse Event Reporting program.

Consumers with questions about the recall can contact Bionpharma at 888-235-2466, Monday through Friday, 9 a.m. to 5 p.m. EST or via email at drugsafety@bionpharma.com.