Class IIIOngoing

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg recall

FDA recall D-0102-2025 · initiated Nov 14, 2024

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

Labeling: Not Elsewhere Classified - Wrong NDC number

Details

Product: Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-849-94. Packaged in sachets
Recalling company: Zydus Pharms USA
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA Nationwide.
Initiated: Nov 14, 2024
FDA report date: Dec 11, 2024

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-0102-2025 ↗

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