clomiPRAMINE Hydrochloride — Class II drug recall D-0153-2026

Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2025-11-12, distributed nationwide. cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N

Recall number	`D-0153-2026`
Product type	Drug
Classification	Class II
Status	Ongoing
Voluntary or mandated	Voluntary
Recalling firm	Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States
Recall initiated	2025-10-22
Classified	2025-11-04
Reported by FDA	2025-11-12
Distributed	Nationwide (US)
Reason classes	chemical contamination, cgmp, specification failure
NDC	`16714-0849`, `16714-0849-01`, `16714-0849-02`, `16714-0849-03`, `16714-0850`, `16714-0850-01`, `16714-0850-02`, `16714-0850-03`, `16714-0851`, `16714-0851-01`, `16714-0851-02`, `16714-0851-03`
Lot numbers	`E400942`, `E400943`, `E400944`, `E405845`, `E405846`, `E407128`, `E407176`, `E410156`, `E410157`, `E410158`
Expiration dates	`2026-01`, `2026-06`, `2026-08`, `2026-12`

Product

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

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0153-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.