FDA DrugsClass II
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 ...
Published: April 22, 2026Recall ID: D-0485-2026Category: drugsCountry: US
Reason for Recall / Hazard
Failed Dissolution Specifications
Product Description & Identification
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
Affected Products
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
Additional Source Details
| Field | Value |
|---|---|
| City | Dublin |
| State | OH |
| Openfda › Unii | JY0WD0UA60 |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 996594 |
| Openfda › Rxcui › 2 | 996603 |
| Openfda › Rxcui › 3 | 996609 |
| Openfda › Rxcui › 4 | 996615 |
| Openfda › Spl id | 64e26acf-3799-4ad1-b91f-cf5766e5ada9 |
| Openfda › Brand name | MEMANTINE HYDROCHLORIDE |
| Openfda › Spl set id | f6ce7cca-d245-44f2-986c-2a8d85dbb5fb |
| Openfda › Package ndc › 1 | 0904-6734-61 |
| Openfda › Package ndc › 2 | 0904-6736-61 |
| Openfda › Package ndc › 3 | 0904-6737-61 |
| Openfda › Package ndc › 4 | 0904-6735-61 |
| Openfda › Product ndc › 1 | 0904-6734 |
| Openfda › Product ndc › 2 | 0904-6736 |
| Openfda › Product ndc › 3 | 0904-6737 |
| Openfda › Product ndc › 4 | 0904-6735 |
| Openfda › Generic name | MEMANTINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | MEMANTINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Major Pharmaceuticals |
| Openfda › Application number | ANDA206028 |
| Openfda › Original packager product ndc › 1 | 68180-246 |
| Openfda › Original packager product ndc › 2 | 68180-247 |
| Openfda › Original packager product ndc › 3 | 68180-248 |
| Openfda › Original packager product ndc › 4 | 68180-249 |
| Event id | 98672 |
| Address 1 | 7000 Cardinal Pl |
| Address 2 | N/A |
| Code info | Lot # N02425, Exp Date: 05/31/2027. |
| Postal code | 43017-1091 |
| Report date | 20260422 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | Failed Dissolution Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260324 |
| Initial firm notification | Letter |
| Center classification date | 20260417 |
Overview
- Recalling FirmThe Harvard Drug Group LLC
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide.