Moderate riskFDA DrugClass II

Memantine ER capsules recalled for failed dissolution specifications

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.

From the FDA notice · Read the official notice ↗ · All The Harvard Drug recalls

What to do

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

Is yours affected?

Compare your label or packaging with the recalled product.

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
Sold in
Nationwide
Made for
Older adults (0 months and older)

Details

Units affected
N/A
Illnesses reported
None reported
Manufactured in
7000 Cardinal Pl, N/A, Dublin, OH, United States
Classification
Class II
Recall number
D-0485-2026

In the FDA's words

Description
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 Failed Dissolution Specifications Lot # N02425, Exp Date: 05/31/2027. Distribution: US Nationwide. Affected quantity: N/A
Hazard
Failed Dissolution Specifications

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