FDA Drug recall D-0844-2020
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmac…
- FDA Drug
- Class III
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class III recall of Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmac… by The Harvard Drug Group, 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-0844-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2019-12-13 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | The Harvard Drug Group |
| Distribution | US |
Product
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152 USA, NDC 0904-6735-61
Reason
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Identifiers
| ndc | 0904-6734-61 |
|---|---|
| ndc | 0904-6736-61 |
| ndc | 0904-6737-61 |
| ndc | 0904-6735-61 |
| code_info | Lot# M02465D |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All The Harvard Drug Group recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0844-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.