Drug recall D-0153-2026
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.
Lots and 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
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Quantity
- N/A
- Distribution
- Nationwide in the US
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 22, 2025
Related products
- Clomipramine Hydrochloride – drug information
- NDC 16714-851 Clomipramine Hydrochloride · Clomipramine Hydrochloride 75 mg/1 · Northstar Rx LLC.
- NDC 16714-850 Clomipramine Hydrochloride · Clomipramine Hydrochloride 50 mg/1 · Northstar Rx LLC.
- NDC 16714-849 Clomipramine Hydrochloride · Clomipramine Hydrochloride 25 mg/1 · Northstar Rx LLC.