Zydus Pharmaceuticals (USA) Inc recalls clomiPRAMINE Hydrochloride
- Recalling company
- Zydus Pharmaceuticals (USA) Inc
- 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
- cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 22, 2025
- Reported
- Nov 12, 2025
- Distribution
- Nationwide in the US
- Status
- Ongoing
- Quantity
- N/A
- Lot / codes
- a) Lot # E410157, Exp Date: 12/2026; Lot # E407176, Exp Date: 08/2026; Lot # E405845, Exp Date: 06/2026; Lot # E400943, Exp Date: 01/2026 b)Lot # E410156, Exp Date: 12/2026; Lot # E400942, Exp Date: 01/2026 c) Lot # E410158, Exp Date: 12/2026; Lot # E407128, Exp Date: 08/2026; Lot # E405846, Exp Date: 06/2026; Lot # E400944, Exp Date: 01/2026
- Company location
- Pennington, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0153-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0153-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.