CLASS III Drug recall · Reported 25 Dec 2019 · FDA Enforcement Report
Memantine Hydrochloride Extended-release Capsules, 28mg recalled
Lupin Pharmaceuticals is recalling Memantine Hydrochloride Extended-release Capsules, 28mg, distributed nationwide in the US. The recall was initiated on 10 Dec 2019 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-0629-2020
- FDA event ID
- 84463
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 Dec 2019
- FDA classified
- 23 Dec 2019
- Reported
- 25 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 10 Dec 2019 | Recall initiated by company | |
| 23 Dec 2019 | Classified by FDA | +13 days |
| 25 Dec 2019 | Published in enforcement report | +2 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: High out of specification result observed at stability studies.
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, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Which lots are affected?
Lot #: H901787, H901788, Exp March 2021
Where was it sold?
Nationwide in the USA
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.
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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 II | Memantine Hydrochloride Extended Release Capsules, 21 mg recalledMemantine Hydrochloride | Lupin Pharmaceuticals | Potency & Assay | Nationwide |