ClomiPRAMINE Hydrochloride recalled over manufacturing violations

Recall date

October 22, 2025

Source

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

Official notice title

Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottl…

Recall number

D-0153-2026

FDA classification

Class II

Brand / firm

Zydus Pharmaceuticals (USA) Inc

Sold / distributed

Nationwide in the US

Why it was recalled

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

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, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India