Zydus Pharmaceuticals (USA) Inc: Drug Recall
Recall #D-0154-2026 · 10/22/2025
Class II: Risk
Recall Details
- Recall Number
- D-0154-2026
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Status
- Ongoing
- Date Initiated
- 10/22/2025
- Location
- Pennington, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Product Description
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 16714-851-03 Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India.
Distribution Pattern
Nationwide in the US
Other Recalls by Zydus Pharmaceuticals (USA) Inc
- Class II: Risk 12/30/2025
- Class III: Low Risk 12/19/2025
- Class II: Risk 10/23/2025
- Class II: Risk 10/22/2025
- Class II: Risk 10/22/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.