Zydus Pharmaceuticals (USA) Inc: clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 1671

Hazard

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

Details from the source

Reason for recall: cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit. Distribution: Nationwide in the US Quantity: N/A Lot/code info: a) Lot # E403069, Exp Date: 04/2026; Lot # E406504, Exp Date: 07/2026; Lot # E309177, Exp Date: 11/2025; Lot # E400262, Exp Date: 12/2025; Lot # E404200, Exp Date: 05/2026 b) Lot # E403070, Exp Date: 04/2026; Lot # E406505, Exp Date: 07/2026; Lot # E407631, Exp Date: 08/2026; Lot # E400263, Exp Date: 12/2025; Lot # E404202, Exp Date: 05/2026 c) Lot # E403071, Exp Date: 04/2026; Lot # E407632, Exp Date: 08/2026; Lot # E405848, E405284, Exp Date: 07/2026; Lot # E400264, Exp Date: 12/2025; Lot # E404201, Exp Date: 05/2026

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.