Memantine Hydrochloride Extended-Release Capsules — Class III drug recall D-1262-2020
Terminated recall by The Harvard Drug Group, reported 2020-05-20, distributed in AL, FL, IA, NY, OH, TX. Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testi
| Recall number | D-1262-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2020-04-24 |
| Classified | 2020-05-13 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2022-08-19 |
| Distributed | AL, FL, IA, NY, OH, TX |
| Quantity | 678 cartons |
| 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 | M02199D, M02246D |
| Expiration dates | 2020-05 |
Product
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61
Reason for recall
Failed dissolution specifications: Low stage 3 results obtained for dissolution 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-1262-2020. 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.