FDA Drug recall D-0435-2017
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…
- FDA Drug
- Class III
- terminated
- Published 2017-01-25
On 2017-01-25 the FDA classified a Class III recall of 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… by Sandoz, citing subpotent Drug: out of specification results for assay test.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0435-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-12-13 |
| Published | 2017-01-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
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
Subpotent Drug: out of specification results for assay test.
Identifiers
| code_info | Lot #: a) FJ6599, Exp 05/17 and b) FJ6600, Exp 05/17 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0435-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.