FDA · Drugs ·
Memantine Hydrochloride Extended-Release recall
The Harvard Drug Group LLC recalled Memantine Hydrochloride Extended-Release on April 22, 2026 because of failed dissolution specifications. It was sold nationwide.
Why it was recalled
Failed Dissolution Specifications
What's recalled
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
Quantity: N/A
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- The Harvard Drug Group LLC, Dublin, OH
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide. - Status
- Ongoing
- Recall number
- D-0485-2026
- Source
- U.S. Food and Drug Administration
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