Lupin Pharmaceuticals Inc. recalls clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc…

Recall date

April 10, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0377-2025

FDA classification

Class II

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

USA nationwide

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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