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Class II · ModerateActive recall

Memantine Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # N02425, Exp Date: 05/31/2027.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMajor Pharmaceuticals
Brand nameMEMANTINE HYDROCHLORIDE
Generic nameMEMANTINE HYDROCHLORIDE
Active ingredient(s)MEMANTINE HYDROCHLORIDE
Distributed by / forMajor Pharmaceuticals, Indianapolis, IN 46268
NDC0904-6734-61
Show the full FDA record
Full product labelMemantine 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
Recalling firmThe Harvard Drug Group LLC
DistributionUS Nationwide.
QuantityN/A
Recall initiated2026-03-24
Report date2026-04-22
Recall completed—
Recall numberD-0485-2026
ClassificationClass II
FDA statusOngoing
Origin on fileDublin OH United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.