D-0443-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 28, 2025
- Initiation Date
- May 13, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22,152 30 sachets/carton
Product Description
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
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 Pattern
Nationwide -in the USA
Code Information
Lot #:M402147, Exp 10/2025; M311637, Exp 07/2025; M402495, Exp 02/2026; M407997, Exp 05/2026; M502246, Exp11/2026.