Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

Recall Insight

This FDA Drug action (record #D-0012-2025) was formally reported on October 23, 2024, with the manufacturer initiating the action on September 17, 2024. It is classified under Critical severity (Class I), with a current status of Terminated. Bionpharma Inc. is listed as the recalling firm, operating out of Princeton, NJ. Federal records indicate 1,980 bottles units are affected.

The documented reason for this recall is: Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria. Distribution data in the federal record shows the product reached: Nationwide in the U.S.A.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.