FDA Drug recall D-0537-2025
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-…
- FDA Drug
- Class II
- terminated
- Published 2025-07-30
On 2025-07-30 the FDA classified a Class II recall of clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-… by Lupin Pharmaceuticals, citing failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample tes….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0537-2025 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2025-06-27 |
| Published | 2025-07-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Reason
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
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 # M300464, exp. date June, 2025 |
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 Lupin Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0537-2025%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.