Amoxicillin for Oral Suspension USP — Class II drug recall D-0440-2017
Terminated recall by Teva Pharmaceuticals USA, reported 2017-02-01, distributed in PR. Subpotency: due to a low, out of specification test result for assay during stability testing.
| Recall number | D-0440-2017 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2016-12-21 |
| Classified | 2017-01-24 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2018-02-06 |
| Distributed | PR |
| Quantity | 133,601 bottles |
| Reason classes | potency, specification failure |
| NDC | 00093-4150-73 |
| Lot numbers | 35432507A, 35434914A, 35435798A, 35437490A, 9/19 |
Product
Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in a 100 mL bottle, Rx only, Manufactured for: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4150-73
Reason for recall
Subpotency: due to a low, 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-0440-2017. 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.