Class IIOngoing

Esomeprazole Magnesium for Delayed-Release Oral Suspension recall

FDA recall D-0443-2025 · initiated May 13, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.

Details

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
Recalling company: Zydus Pharms USA
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide -in the USA
Initiated: May 13, 2025
FDA report date: May 28, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0443-2025 ↗

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