Multi event Drug Recall Enforcement Report Class II voluntary initiated by Zydus Pharmaceuticals (USA) Inc, originally initiated on 05-13-2025 for the product 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 The product was recalled due to failed impurities/degradation specifications: out-of-specification test results obtained for any individual unknown degradation product during related compounds testing during long term stability.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0442-2025 | 05-13-2025 | 05-28-2025 | Class II | 30,674 30 sachets/carton | 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 | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. | Ongoing |
| D-0443-2025 | 05-13-2025 | 05-28-2025 | Class II | 22,152 30 sachets/carton | Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 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 68382-848-94 | Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. | Ongoing |
Recalled Products
