Amoxicillin for Oral Suspension USP — Class II drug recall D-1470-2016
Terminated recall by Teva North America, reported 2016-08-31, distributed nationwide. Superpotent drug: Out of specification test result for assay during stability testing.
| Recall number | D-1470-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva North America, Horsham, PA, United States |
| Recall initiated | 2016-06-24 |
| Classified | 2016-08-24 |
| Reported by FDA | 2016-08-31 |
| Terminated | 2017-02-07 |
| Distributed | Nationwide (US) |
| Quantity | 53,328 bottles |
| Reason classes | potency, specification failure |
| 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 | 35434158A, 6/17 |
Product
Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76
Reason for recall
Superpotent drug: Out of specification test result for assay during stability testing.
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-1470-2016. 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.