Recall: D-0485-2026

Class II - Potentially Harmful

Class IIClassification

2026-03-24Initiated

OngoingStatus

The Harvard Drug Group LLCFirm

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

Distribution

US Nationwide.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.