FDA Recall D-0012-2025
Bionpharma Inc. · Princeton, NJ
Class I — life-threatening Terminated 364 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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.
Reason for recall
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Recall record
- Recall number
D-0012-2025- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the U.S.A.
- Recall initiated
- 2024-09-17
- Classified by FDA Center
- 2024-10-15
- FDA published
- 2024-10-23
- Terminated
- 2025-09-16
- Recalling firm
- Bionpharma Inc.
- Firm location
- Princeton, NJ
Drug identification
- Brand name(s)
- ATOVAQUONE
- Generic name(s)
- ATOVAQUONE
- Manufacturer(s)
- Bionpharma Inc.
- NDC(s)
69452-252- Route(s)
- ORAL