FDA Drug recall D-0629-2020
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68…
- FDA Drug
- Class III
- terminated
- Published 2019-12-25
On 2019-12-25 the FDA classified a Class III recall of Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68… by Lupin Pharmaceuticals, citing failed Dissolution Specifications: High out of specification result observed at stability studies.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0629-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-12-10 |
| Published | 2019-12-25 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
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
Reason
Failed Dissolution Specifications: High out of specification result observed at stability studies.
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 #: H901787, H901788, Exp March 2021 |
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-0629-2020%22
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