Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Atovaquone recalled?

Yes — there is an active recall. 1 ongoing FDA recall mention Atovaquone (6 total). Check the affected lots below.

Most common reason: Microbial contamination (3 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Atovaquone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Atovaquone recalls on record

none so far in 2026; 6 on record, newest first
Class I · High risk

Atovaquone Oral Suspension

Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

Terminated Microbial contamination Bionpharma Inc. NDC 69452-252-87 D-0012-2025
Class I · High risk

Atovaquone Oral Suspension USP

Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.

Ongoing Microbial contamination Camber Pharmaceuticals Inc. NDC 31722-629-21 D-0567-2023
Class II · Moderate risk

All Malarone

Lack of Processing Controls

Terminated cGMP deviation Reliable Rexall-A Compounding Pharmacy D-1136-2016
Class II · Moderate risk

Atovaquone active pharmaceutical ingredient packaged in varying…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-528-2015