Donepezil Hydrochloride Tablets — Class III drug recall D-0435-2017
Terminated recall by Sandoz Inc, reported 2017-01-25, distributed nationwide. Subpotent Drug: out of specification results for assay test.
| Recall number | D-0435-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sandoz Inc, Princeton, NJ, United States |
| Recall initiated | 2016-12-13 |
| Classified | 2017-01-19 |
| Reported by FDA | 2017-01-25 |
| Terminated | 2017-09-14 |
| Distributed | Nationwide (US) |
| Reason classes | potency, specification failure |
| NDC | 00781-5275-10, 00781-5275-31 |
Product
Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.
Reason for recall
Subpotent Drug: out of specification results for assay test.
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-0435-2017. 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.