clomiPRAMINE Hydrochloride Capsules USP 25 mg — Class II drug recall D-0537-2025
Terminated recall by Lupin Pharmaceuticals Inc., reported 2025-07-30, distributed nationwide. Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product t
| Recall number | D-0537-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Naples, FL, United States |
| Recall initiated | 2025-06-27 |
| Classified | 2025-07-21 |
| Reported by FDA | 2025-07-30 |
| 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 | M300464 |
Product
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, 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 retention sample testing at expiry.
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-0537-2025. 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.