Atovaquone Oral Suspension USP — Class I drug recall D-0444-2024
Terminated recall by AvKARE, reported 2024-04-24, distributed nationwide. Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
| Recall number | D-0444-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AvKARE, Pulaski, TN, United States |
| Recall initiated | 2024-03-28 |
| Classified | 2024-04-16 |
| Reported by FDA | 2024-04-24 |
| Terminated | 2024-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 153 cartons |
| Reason classes | microbial contamination, sterility |
| Pathogens | bacillus cereus |
| NDC | 50268-0086-12 |
| Lot numbers | AW0221A |
| Expiration dates | 2025-08-30 |
Product
Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.
Reason for recall
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
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-0444-2024. 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.