Recall
FDAHealthMarch 24, 2026

The Harvard Drug Group LLC — Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis,

⚠️ Failed Dissolution Specifications

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 24, 2026

US Nationwide.

What's affected?

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
Lot code
N02425

Additional details

Lot # N02425, Exp Date: 05/31/2027.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: N/A.

View original FDA notice →

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