CLASS II Drug recall · Reported 19 Feb 2020 · FDA Enforcement Report
Memantine Hydrochloride Extended Release Capsules, 21 mg recalled
Lupin Pharmaceuticals is recalling Memantine Hydrochloride Extended Release Capsules, 21 mg, distributed nationwide in the US. The recall was initiated on 12 Feb 2020 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-0855-2020
- FDA event ID
- 84948
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Feb 2020
- FDA classified
- 24 Feb 2020
- Reported
- 19 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 12 Feb 2020 | Recall initiated by company | |
| 19 Feb 2020 | Published in enforcement report | +7 days |
| 24 Feb 2020 | Classified by FDA | +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: Low out of specification results observed in dissolution test at six-month long-term stability study.
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, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
Where it was distributed
Nationwide within the United States.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Which lots are affected?
Lot #: H900330, exp. date 11/2020.
Where was it sold?
Nationwide within the United States.
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.
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|---|---|---|---|---|---|
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| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
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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 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 III | Memantine Hydrochloride Extended-release Capsules, 28mg recalledMemantine Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | Nationwide |