AMOXICILLIN for Oral Suspension USP — Class II drug recall D-0165-2024
Terminated recall by CARDINAL HEALTHCARE, reported 2024-01-03, distributed nationwide. CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
| Recall number | D-0165-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CARDINAL HEALTHCARE, Dublin, OH, United States |
| Recall initiated | 2022-01-26 |
| Classified | 2023-12-26 |
| Reported by FDA | 2024-01-03 |
| Terminated | 2024-09-29 |
| Distributed | Nationwide (US) |
| Quantity | 3 units |
| Reason classes | labeling, cgmp |
| NDC | 00093-2263, 00093-2263-01, 00093-2264, 00093-2264-01, 00093-2267, 00093-2267-01, 00093-2268, 00093-2268-01, 00093-3107, 00093-3107-01, 00093-3107-05, 00093-3109, 00093-3109-05, 00093-3109-53, 00093-4155, 00093-4155-73, 00093-4155-79, 00093-4155-80, 00093-4160, 00093-4160-73, 00093-4160-76, 00093-4160-78, 00093-4161, 00093-4161-73, 00093-4161-76 and 1 more |
| Lot numbers | 35447184A |
Product
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73
Reason for recall
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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-0165-2024. 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.