Memantine Hydrochloride Extended-release Capsules — Class III drug recall D-0629-2020
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-12-25, distributed nationwide. Failed Dissolution Specifications: High out of specification result observed at stability studies.
| Recall number | D-0629-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-12-10 |
| Classified | 2019-12-23 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2021-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 3,726 bottles |
| Reason classes | specification failure |
| NDC | 68180-0246, 68180-0246-06, 68180-0247, 68180-0247-06, 68180-0247-09, 68180-0248, 68180-0248-06, 68180-0249, 68180-0249-02, 68180-0249-06, 68180-0249-09 |
| Lot numbers | H901787, H901788 |
| Expiration dates | 2021-03-20 |
Product
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
Reason for recall
Failed Dissolution Specifications: High out of specification result observed at stability studies.
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-0629-2020. 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.