Zydus Pharmaceuticals (USA) Inc: Drug Recall
Recall #D-0442-2025 · 05/13/2025
Class II: Risk
Recall Details
- Recall Number
- D-0442-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Zydus Pharmaceuticals (USA) Inc
- Status
- Ongoing
- Date Initiated
- 05/13/2025
- Location
- Pennington, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,674 30 sachets/carton
Reason for Recall
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Product Description
Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94
Distribution Pattern
Nationwide -in the USA
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.