Memantine Hydrochloride Extended-Release recall
FDA recall D-0485-2026 · initiated Mar 24, 2026
The Harvard Drug Group LLC recalled Memantine Hydrochloride Extended-Release in Mar 2026 — an FDA Class II recall (D-0485-2026) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- 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
- Recalling company
- The Harvard Drug Group LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Mar 24, 2026
- FDA report date
- Apr 22, 2026
Frequently asked
- Was Memantine Hydrochloride Extended-Release recalled?
- The Harvard Drug Group LLC recalled Memantine Hydrochloride Extended-Release in Mar 2026 — an FDA Class II recall (D-0485-2026) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Memantine Hydrochloride Extended-Release recalled?
- Per the FDA enforcement record, the reason for recall D-0485-2026 was: Failed Dissolution Specifications
- Is a recalled Memantine Hydrochloride Extended-Release dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Memantine Hydrochloride Extended-Release are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # N02425, Exp Date: 05/31/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0485-2026.