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Home › FDA recalls › Memantine Hydrochloride Extended-Release
CLASS II · ModerateFDA

The Harvard Drug Group LLC recalls Memantine Hydrochloride Extended-Release

📅 Mar 24, 2026 · 📍 Nationwide
Recalling company
The Harvard Drug Group LLC
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
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Mar 24, 2026
Reported
Apr 22, 2026
Distribution
US Nationwide.
Status
Ongoing
Quantity
N/A
Lot / codes
Lot # N02425, Exp Date: 05/31/2027.
Company location
Dublin, OH
Recall type
Voluntary: Firm initiated
Recall number
D-0485-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0485-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.