Atovaquone Oral Suspension — Class I drug recall D-0012-2025
Terminated recall by Bionpharma Inc., reported 2024-10-23, distributed nationwide. Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacte
| Recall number | D-0012-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bionpharma Inc., Princeton, NJ, United States |
| Recall initiated | 2024-09-17 |
| Classified | 2024-10-15 |
| Reported by FDA | 2024-10-23 |
| Terminated | 2025-09-16 |
| Distributed | Nationwide (US) |
| Quantity | 1,980 bottles |
| Reason classes | microbial contamination, sterility |
| NDC | 69452-0252, 69452-0252-87 |
| Lot numbers | 2310083 |
| Expiration dates | 2025-09-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0012-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.