WhichRecall
Class IIReported 2025-05-28

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

Recalled by Zydus Pharmaceuticals (USA) Inc

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.

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Recall Number
D-0442-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2025-05-13
Reported
2025-05-28
Distribution
Nationwide -in the USA
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.
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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