Memantine Hydrochloride Extended-Release recall (The Harvard Drug Group LLC)
DrugClass IIOngoing
Summary: The Harvard Drug Group LLC is recalling 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. Reason: Failed Dissolution Specifications.
What is being 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
Why
Failed Dissolution Specifications
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot # N02425, Exp Date: 05/31/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0485-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 24, 2026 |
| Reported | April 22, 2026 |
| Company | The Harvard Drug Group LLC |
| Company location | Dublin, OH, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
More recalls from The Harvard Drug Group LLC · all drug recalls · recalls from March 2026