Amoxicillin and Clavulanate Potassium Tablets — Class III drug recall D-0868-2017
Terminated recall by Sandoz Inc, reported 2017-06-07, distributed in NY, OH. Subpotent Drug; Clavulanic Acid
| Recall number | D-0868-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2017-04-26 |
| Classified | 2017-05-26 |
| Reported by FDA | 2017-06-07 |
| Terminated | 2019-08-19 |
| Distributed | NY, OH |
| Quantity | 4,464 bottles |
| Reason classes | potency |
| NDC | 00781-1831, 00781-1831-01, 00781-1831-13, 00781-1831-20, 00781-1852, 00781-1852-01, 00781-1852-13, 00781-1852-20, 00781-1874, 00781-1874-31, 00781-6102, 00781-6102-46, 00781-6102-52, 00781-6102-57, 00781-6104, 00781-6104-46, 00781-6104-52, 00781-6104-57 |
| Lot numbers | FP8735 |
Product
Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20
Reason for recall
Subpotent Drug; Clavulanic Acid
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-0868-2017. 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.