FDA recall D-0537-2025

Lupin Pharmaceuticals Inc. · Class II · drug

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.

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2025-06-27
Report date: 2025-07-30
Termination date: 2026-01-05
Voluntary/Mandated: Voluntary: Firm initiated
Location: Naples, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0537-2025