Amoxicillin for Oral Suspension USP — Class II drug recall D-1205-2019
Terminated recall by Teva Pharmaceuticals USA, reported 2019-04-24, distributed nationwide. Subpotent Product: assay results for Amoxicillin were below the specification limits.
| Recall number | D-1205-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2019-04-12 |
| Classified | 2019-04-18 |
| Reported by FDA | 2019-04-24 |
| Terminated | 2020-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 171,488 |
| Reason classes | potency |
| NDC | 00093-4150-79, 00093-4150-80 |
| Lot numbers | 35436769A, 35438389A, 35438390A, 35440838A |
| Expiration dates | 2019-05, 2020-01, 2020-10, 2021-09 |
Product
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle (NDC 0093-4150-79), Rx Only, Manufactured in Canada By: Teva Canada Limited Toronto, Canada, M1B2K9, Manufactured For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454.
Reason for recall
Subpotent Product: assay results for Amoxicillin were below the specification limits.
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-1205-2019. 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.