clomiPRAMINE hydrochloride Capsules USP — Class II drug recall D-0377-2025
Terminated recall by Lupin Pharmaceuticals Inc., reported 2025-04-30, distributed nationwide. Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product t
| Recall number | D-0377-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Naples, FL, United States |
| Recall initiated | 2025-04-10 |
| Classified | 2025-04-18 |
| Reported by FDA | 2025-04-30 |
| Terminated | 2026-01-05 |
| Distributed | Nationwide (US) |
| Quantity | 2,724 bottles |
| Reason classes | specification failure |
| NDC | 68180-0492, 68180-0492-01, 68180-0492-06, 68180-0492-07, 68180-0492-09, 68180-0493, 68180-0493-01, 68180-0493-06, 68180-0493-07, 68180-0493-09, 68180-0494, 68180-0494-01, 68180-0494-06, 68180-0494-07, 68180-0494-09 |
| Lot numbers | M300442 |
| Expiration dates | 2025-06-30 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0377-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.