Zydus Pharmaceuticals recalls 20mg esomeprazole suspension due to impurities that could cause harm. Affected lots from M402147 to M502246 with specific expiration dates.
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 20mg esomeprazole magnesium for delayed-release oral suspension. The product may contain impurities that could cause harm, so affected users should stop using it and contact their doctor.
The product failed impurities testing during long-term stability. This means the medication may contain harmful substances that could cause health issues if taken.
People with prescriptions for this medication are affected. Those who have the specific lot numbers listed in the recall are at highest risk.
Check the product label for the lot number: M402147 (exp 10/2025), M311637 (exp 07/2025), M402495 (exp 02/2026), M407997 (exp 05/2026), or M502246 (exp 11/2026).
Discard the product immediately as it may contain harmful impurities.
No, the product has failed impurities testing and may contain harmful substances. Do not take it.
Affected lot numbers are M402147 (exp 10/2025), M311637 (exp 07/2025), M402495 (exp 02/2026), M407997 (exp 05/2026), and M502246 (exp 11/2026).
Check the product label for the lot number listed above. This product is prescription-only and sold under the NDC 68382-848-94.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0443-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0443-2025 from Zydus Pharmaceuticals. 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.