Atovaquone Oral Suspension USP — Class I drug recall D-0567-2023
Ongoing recall by Camber Pharmaceuticals Inc., reported 2023-05-17, distributed nationwide. Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found i
| Recall number | D-0567-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Camber Pharmaceuticals Inc., Piscataway, NJ, United States |
| Recall initiated | 2023-03-13 |
| Classified | 2023-05-08 |
| Reported by FDA | 2023-05-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,568 bottles |
| Reason classes | microbial contamination, sterility |
| Pathogens | bacillus cereus |
| NDC | 31722-0629, 31722-0629-21 |
| Lot numbers | E220182 |
| Expiration dates | 2023-12-31 |
Product
Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC# 31722-629-21.
Reason for recall
Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus cereus, found in product during testing of repackaged product.
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-0567-2023. 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.