FDA recall D-0485-2026

The Harvard Drug Group LLC · Class II · drug

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

Distribution

US Nationwide.

Key facts

Status: Ongoing
Initiation date: 2026-03-24
Report date: 2026-04-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0485-2026