CLASS II ONGOING Drug recall · Reported 22 Apr 2026 · FDA Enforcement Report
Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalled
The Harvard Drug Group is recalling Memantine Hydrochloride Extended-Release, Capsules, 7 mg ( blister packs), distributed nationwide in the US. The recall was initiated on 24 Mar 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0485-2026
- FDA event ID
- 98672
- Recalling firm
- The Harvard Drug Group, Dublin, OH
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Mar 2026
- FDA classified
- 17 Apr 2026
- Reported
- 22 Apr 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 24 Mar 2026 | Recall initiated by company | |
| 17 Apr 2026 | Classified by FDA | +24 days |
| 22 Apr 2026 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lot # N02425, Exp Date: 05/31/2027.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalled | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister pack) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Memantine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Namzaric (memantine HCl extended release recalled by Cardinal HealthNamzaric | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Memantine Hydrochloride Extended-Release Capsules recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | 6 states |
| Drug | CLASS III | Memantine Hydrochloride Extended-release Capsules, 28mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended Release Capsules, 21 mg recalledMemantine Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Memantine Hydrochloride Extended-release Capsules, 28mg recalledMemantine Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | Nationwide |