FDA Drug recall D-0485-2026
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major…
- FDA Drug
- Class II
- ongoing
- Published 2026-04-22
On 2026-04-22 the FDA classified a Class II recall of Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major… by The Harvard Drug Group, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0485-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-24 |
| Published | 2026-04-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
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
Failed Dissolution Specifications
Identifiers
| ndc | 0904-6734-61 |
|---|---|
| ndc | 0904-6736-61 |
| ndc | 0904-6737-61 |
| ndc | 0904-6735-61 |
| code_info | Lot # N02425, Exp Date: 05/31/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0485-2026%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.