FDAFDA · Food and drugs·Recall number D-0442-2025
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
Published May 28, 2025 · Recall initiated: May 13, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ESOMEPRAZOLE MAGNESIUM
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Distributor
- Nationwide -in the USA
- Lot
- 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.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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