Drug Recall: 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 Ph
Zydus Pharmaceuticals (USA) Inc · May 13, 2025
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.
Product Description
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
Distribution
Nationwide -in the USA
States Affected
NATIONWIDE
Quantity Affected
30,674 30 sachets/carton
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0442-2025
Status: ongoing
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