FDA Drug recall D-0377-2025
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 212…
- FDA Drug
- Class II
- terminated
- Published 2025-04-30
On 2025-04-30 the FDA classified a Class II recall of clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 212… by Lupin Pharmaceuticals, citing failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term s….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0377-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2025-04-10 |
| Published | 2025-04-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 441 108 INDIA, NDC 68180-492-01
Reason
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Identifiers
| ndc | 68180-492-01 |
|---|---|
| ndc | 68180-492-07 |
| ndc | 68180-492-09 |
| ndc | 68180-492-06 |
| ndc | 68180-493-01 |
| ndc | 68180-493-07 |
| ndc | 68180-493-09 |
| ndc | 68180-493-06 |
| ndc | 68180-494-01 |
| ndc | 68180-494-07 |
| ndc | 68180-494-09 |
| ndc | 68180-494-06 |
| code_info | Lot #: M300442, Exp Date: 6/30/2025 |
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-0377-2025%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.