Class II
Ongoing
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
This recall is currently active, issued May 28, 2025. It was issued by Zydus Pharmaceuticals (Usa) Inc.
- Company
- Zydus Pharmaceuticals (Usa) Inc
- Recall Initiated
- May 13, 2025
- Posted
- May 28, 2025
- Recall Number
- D-0442-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 30,674 30 sachets/carton
- Firm Location
- Pennington, NJ, United States
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide -in the USA
Lot / Code Info
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.
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