FDA recall, , Moderate risk
Major Pharmaceuticals Memantine Hydrochloride Extended-Release Capsules
Memantine Hydrochloride Extended-Release Capsules failed dissolution specifications.
Summary by Recall Canary from the FDA notice
What happened
The Harvard Drug Group LLC, of Dublin, Ohio, recalled Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, after the product failed dissolution specifications. The recall began March 24, 2026, and was added to the FDA's Enforcement Report on April 10, 2026. The product was distributed nationwide in the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Memantine Hydrochloride Extended-Release Capsules
- NDC
- 0904-6734-61
- Lot code
- N02425
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- The Harvard Drug Group LLCDublin, Ohio
- Hazard
- Drug dissolving problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98672
- Recall number
- D-0485-2026
All recalls from The Harvard Drug Group LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
