Zydus Pharmaceuticals (USA) Inc recalls Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Man
Recalled May 28, 2025 · FDA recall D-0442-2025 · Zydus Pharmaceuticals (USA)
Hazard
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability. · FDA Class II
Units
30,674 30 sachets/carton
Sold at
Nationwide -in the USA
Description
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
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
Manufacturer(s)
Zydus Pharmaceuticals (USA) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →