Donepezil HCl tablets — Class III drug recall D-0680-2017
Terminated recall by Mckesson Packaging Services, reported 2017-05-03, distributed in CO, LA, OH. Supotent: Out of Specification result for assay test during routine stability testing.
| Recall number | D-0680-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Packaging Services, Concord, NC, United States |
| Recall initiated | 2017-01-04 |
| Classified | 2017-04-25 |
| Reported by FDA | 2017-05-03 |
| Terminated | 2017-08-24 |
| Distributed | CO, LA, OH |
| Quantity | 476 cartons |
| Reason classes | potency, specification failure |
| NDC | 63739-0678-10 |
| Lot numbers | 0111593 |
| Expiration dates | 2017-05 |
Product
Donepezil HCl tablets, 10mg, packaged in 10x10 blister packs per carton (100 Unit Dose) container, Rx only, Manufactured by Sandoz, Inc., 506 Carnegie Center, Suite 400, Princeton, NJ 08805, Distributed by: McKesson Packaging Services, 7101 Weddington Rd, Concord, NC 28027, NDC 63739-678-10
Reason for recall
Supotent: Out of Specification result for assay test during routine 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-0680-2017. 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.