FDA Drug recall D-0012-2025
Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-…
- FDA Drug
- Class I
- terminated
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class I recall of Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-… by Bionpharma, citing microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0012-2025 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2024-09-17 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Bionpharma |
| Distribution | US |
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
Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
Identifiers
| ndc | 69452-252-87 |
|---|---|
| code_info | Lot # 2310083, Exp. 09/30/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0012-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.