FDA-Drug2026-04-22Class IIPROCESSING DEFECT

Major Pharmaceuticals memantine hydrochloride 7 mg capsules recalled for failed dissolution

OTHERNationwide distribution

Stop using recalled memantine hydrochloride capsules

Major Pharmaceuticals is recalling memantine hydrochloride extended-release 7 mg capsules (lot N02425, expiring 05/31/2027) because the capsules may not dissolve properly in the body. This means the medication may not work as intended. The affected capsules were distributed nationwide.

  • Contact your pharmacist or doctor if you have this medication
  • Do not take capsules from lot N02425 without talking to your doctor first
  • Your doctor may prescribe an alternative or provide a replacement
Hazard

Failed Dissolution Specifications

Sold states
US Nationwide.
Affected count
N/A
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Products
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

Official notice

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

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