FDA Drug recall D-0855-2020
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2020-02-19
On 2020-02-19 the FDA classified a Class II recall of Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc by Lupin Pharmaceuticals, citing failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0855-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-02-12 |
| Published | 2020-02-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
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
Reason
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Identifiers
| ndc | 68180-246-06 |
|---|---|
| ndc | 68180-249-06 |
| ndc | 68180-249-09 |
| ndc | 68180-249-02 |
| ndc | 68180-247-06 |
| ndc | 68180-247-09 |
| ndc | 68180-248-06 |
| code_info | Lot #: H900330, exp. date 11/2020. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0855-2020%22
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