CLASS III Drug recall · Reported 20 May 2020 · FDA Enforcement Report
Memantine Hydrochloride Extended-Release Capsules recalled
The Harvard Drug Group is recalling Memantine Hydrochloride Extended-Release Capsules, 28 mg per unit dose, distributed in Alabama, Florida, Iowa, New York, Ohio, Texas. The recall was initiated on 24 Apr 2020 and the FDA has classified it as Class III.
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-1262-2020
- FDA event ID
- 85566
- Recalling firm
- The Harvard Drug Group, Livonia, MI
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Apr 2020
- FDA classified
- 13 May 2020
- Reported
- 20 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 24 Apr 2020 | Recall initiated by company | |
| 13 May 2020 | Classified by FDA | +19 days |
| 20 May 2020 | Published in enforcement report | +7 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: Low stage 3 results obtained for dissolution during routine stability testing.
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, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61
Where it was distributed
AL, FL, IA, NY, OH, TX
Questions about this recall
Why was it recalled?
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Which lots are affected?
Lot #: M02199D, M02246D, Exp 5/2020
Where was it sold?
AL, FL, IA, NY, OH, TX
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | 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 |
Other Memantine recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| 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, 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 |