Recalls / Class I
Class ID-0012-2025
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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.
- Brand name
- Atovaquone
- Generic name
- Atovaquone
- Active ingredient
- Atovaquone
- Route
- Oral
- NDC
- 69452-252
- FDA application
- ANDA212918
- Affected lot / code info
- Lot # 2310083, Exp. 09/30/2025
Why it was recalled
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Recalling firm
- Firm
- Bionpharma Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 400 Alexander Park Ste 2-4b, Princeton, New Jersey 08540-6539
Distribution
- Quantity
- 1,980 bottles
- Distribution pattern
- Nationwide in the U.S.A.
Timeline
- Recall initiated
- 2024-09-17
- FDA classified
- 2024-10-15
- Posted by FDA
- 2024-10-23
- Terminated
- 2025-09-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0012-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.