Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Esomeprazole Magnesium for Delayed-Release Oral Suspension Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zydus Pharmaceuticals (USA) Inc directly.
Affected Products
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
Quantity: 22,152 30 sachets/carton
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zydus Pharmaceuticals (USA) Inc
Zydus Pharmaceuticals (USA) Inc has 51 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report