Class IITerminated

clomiPRAMINE hydrochloride Capsules USP recall

FDA recall D-0377-2025 · initiated Apr 10, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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.

Details

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
Recalling company: Lupin Pharms
Classification: Class II
Status: Terminated
Type: Voluntary: Firm initiated
Distribution: USA nationwide
Initiated: Apr 10, 2025
FDA report date: Apr 30, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0377-2025 ↗

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