Memantine Hydrochloride Extended-Release — Class II drug recall D-0485-2026
Ongoing recall by The Harvard Drug Group LLC, reported 2026-04-22, distributed nationwide. Failed Dissolution Specifications
| Recall number | D-0485-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC, Dublin, OH, United States |
| Recall initiated | 2026-03-24 |
| Classified | 2026-04-17 |
| Reported by FDA | 2026-04-22 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 00904-6734, 00904-6734-61, 00904-6735, 00904-6735-61, 00904-6736, 00904-6736-61, 00904-6737, 00904-6737-61 |
| Lot numbers | N02425 |
| Expiration dates | 2027-05-31 |
Product
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
Reason for recall
Failed Dissolution Specifications
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-0485-2026. 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.