Testing found this recalled medicine can have a deadly bacterial contamination


A drug used to treat a form of pneumonia has been recalled after testing found it might be as deadly as the infection it’s supposed to treat.

AvKARE recalled one lot of Atovaquone Oral Suspension after third-party testing discovered a potential Bacillus cereus contamination in the medicine.

As for what that means, the risk statement in the AvKARE recall notice says: “In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections.”

Endocarditis, the Mayo Clinic explains, is an “inflammation of the inner lining of the heart’s chambers and valves.” “Necrotizing soft tissue infections” are, Johns Hopkins Medicine says, “a serious, life-threatening condition that requires immediate treatment to keep it from destroying skin, muscle, and other soft tissues.”

AvKARE pulled only lot No. AW0221A, expiration date 08/2025 of Atovaquone Oral Suspension, USP 750mg/5mL. The NDC number and the UPC number are the game — 5026808612 — but the NDC number is divided into three parts, after the fifth number and the eighth number. The drug went to wholesalers around the country from March 18 through March 21.

Packaging for Atovaquone Oral Suspension.

Packaging for Atovaquone Oral Suspension.

The drugs came in a carton. If you have this drug, stop using it immediately. Then either throw it out or return it to the store for a refund.

If you have a medical reaction to the medicine, call your medical professional. Then contact the FDA’s MedWatch program either online or at 800-332-1088.

Questions about the recall can be directed to AvKARE at 855-361-3993 or, Monday through Friday, 9 a.m. to 5 p.m., Eastern time.

The outer box of Atovaquone Oral Suspension.

The outer box of Atovaquone Oral Suspension.


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