Contaminated Antimicrobial Under Class I Recall

Nearly 2000 bottles of atovaquone oral suspension distributed by Bionpharma Inc. are under a Class I recall for contamination with Cohnella bacteria, according to the October 23, 2024, US Food and Drug Administration (FDA) Enforcement Report.

A Class I recall designation is the FDA’s most significant and warns that use of the affected product could cause serious adverse health consequences or death.

“We take these findings seriously and are taking immediate action to address the situation,” Biopharma stated in a September 17, 2024, announcement. 

The recall affects atovaquone oral suspension, 750 mg/5 mL, in 210-mL bottles (NDC 69452-252-87) from lot 2310083 (Exp. 9/30/25). The product was manufactured by CoreRx Inc., Clearwater, Florida, and distributed throughout the United States by Bionpharma via wholesalers and retailers between December 21, 2023, and June 20, 2024.

Bionpharma voluntarily initiated the recall September 17, 2024. On October 15, 2024, the FDA issued its Class I designation.

In immunocompromised patients, “there is a reasonable probability that microbial contamination of atovaquone oral suspension can result in disseminated, life-threatening infections such as inflammation of the heart and permanent damage to soft tissue,” the firm stated.

At the time of the statement, Bionpharma had not received any reports of adverse events related to the recall. 

Atovaquone is a quinone antimicrobial prescription drug indicated for the prevention and treatment of Pneumocycstis jirovecii pneumonia (formerly known as PCP for Pneumocystis carinii pneumonia) in adults and adolescents 13 years and older.