September 2024 FDA Recall Atovaquone by Bionpharma Inc.
D-0012-2025 - Microbial Contamination of a Non-sterile Product
This Class I drug recall was voluntarily initiated by Bionpharma Inc. on September 17, 2024 for the product Atovaquone. The FDA reported the reason for recall as microbial contamination of a non-sterile product. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0012-2025
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
09-17-2024
10-23-2024
1,980 bottles
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bionpharma Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the U.S.A.
09-16-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.
Batch or Lot Expiration Information
Lot# 2310083, Exp. 09/30/2025
