Recall: D-0443-2025

Class II - Potentially Harmful

Class IIClassification

2025-05-13Initiated

OngoingStatus

Zydus Pharmaceuticals (USA) InFirm

Product

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

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.