Drug recall D-0442-2025
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
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.
Lots and codes
Lot # M311638, Exp 07/2025, M400374, Exp 10/2025, M402496, Exp 02/2026, M407998, Exp 05/2026, M502247, Exp 11/2026, M414770, M414512, Exp 09/2026.
Recall details
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc, Pennington, NJ
- Quantity
- 30,674 30 sachets/carton
- Distribution
- Nationwide -in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 13, 2025
Related products
- Esomeprazole Magnesium – drug information
- NDC 68382-848 Esomeprazole Magnesium · Esomeprazole Magnesium Dihydrate 20 mg/1 · Zydus Pharmaceuticals USA Inc.
- NDC 68382-849 Esomeprazole Magnesium · Esomeprazole Magnesium Dihydrate 40 mg/1 · Zydus Pharmaceuticals USA Inc.