FDA-Drug2025-07-30Class II
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Lupin Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Sold states
Nationwide.
Affected count
2,724 bottles
Manufactured in
5801 Pelican Bay Blvd, Suite 500, Naples, FL, United States
Products
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0537-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief