Zydus Pharmaceuticals recalls 40mg esomeprazole suspension due to impurities in long-term stability testing. This may cause health risks. Check NDC 68382-849-94 and lot numbers for affected products.
Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation product during Related Compounds testing during long term stability.
Zydus Pharmaceuticals is recalling esomeprazole magnesium for delayed-release oral suspension (40mg, 30-count packets) because tests showed impurities that could degrade the product over time. This recall affects patients taking this medication who may face health risks from unstable drug formulations.
The product failed stability testing for impurities, meaning the medication could degrade over time. This degradation might lead to inconsistent dosing or reduced effectiveness, but the recall does not mention immediate health risks.
Patients prescribed this medication by a doctor are affected. Those with chronic conditions requiring regular use of this drug are at higher risk due to potential instability.
Check for NDC 68382-849-94 on the product label. Look for lot numbers M311638 (exp 07/2025) through M414770 (exp 09/2026).
Look for NDC 68382-849-94 and lot numbers M311638 through M414770 on the packaging.
The recall indicates potential impurities that could affect stability, but the product is not considered unsafe for immediate use. Patients should follow the recall instructions.
Check the NDC code 68382-849-94 and lot numbers M311638 through M414770 on the product label.
The recall does not specify a remedy, so contact your doctor or pharmacist for guidance on next steps.
We’ve drafted a message you can send Zydus Pharmaceuticals (USA) Inc to request your refund or repair — edit it as you like.
Subject: Recall D-0442-2025 — Zydus Pharmaceuticals (USA) Inc Zydus Pharmaceuticals (USA) Inc Hello, I own a Zydus Pharmaceuticals (USA) Inc that is covered by recall D-0442-2025 from Zydus Pharmaceuticals (USA) Inc. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
