FDA Recall D-0485-2026
The Harvard Drug Group LLC · Dublin, OH
Class II Ongoing 51 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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 for recall
Failed Dissolution Specifications
Recall record
- Recall number
D-0485-2026- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide.
- Recall initiated
- 2026-03-24
- Classified by FDA Center
- 2026-04-17
- FDA published
- 2026-04-22
- Recalling firm
- The Harvard Drug Group LLC
- Firm location
- Dublin, OH
Drug identification
- Brand name(s)
- MEMANTINE HYDROCHLORIDE
- Generic name(s)
- MEMANTINE HYDROCHLORIDE
- Manufacturer(s)
- Major Pharmaceuticals
- NDC(s)
0904-6734, 0904-6736, 0904-6737, 0904-6735- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.