FDA Drug recall D-1262-2020
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pith…
- FDA Drug
- Class III
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class III recall of Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pith… by The Harvard Drug Group, citing failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1262-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-04-24 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | AL, FL, IA, NY, OH, TX |
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
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Identifiers
| ndc | 0904-6734-61 |
|---|---|
| ndc | 0904-6736-61 |
| ndc | 0904-6737-61 |
| ndc | 0904-6735-61 |
| code_info | Lot #: M02199D, M02246D, Exp 5/2020 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All The Harvard Drug Group recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1262-2020%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.