Zydus Pharmaceuticals recalls 0.5mg Entecavir tablets due to failed impurity tests. This medication is prescription-only and may contain unsafe levels of organic impurities.
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Zydus Pharmaceuticals is recalling prescription Entecavir tablets after testing found unsafe levels of an organic impurity. This could pose a health risk to patients taking the medication.
The tablets failed impurity tests, meaning they may contain unsafe levels of an organic compound. This could potentially cause health issues for patients taking the medication as directed.
Patients prescribed Entecavir tablets by a doctor are affected. Those using the medication without a prescription are not impacted.
Check for the 0.5 mg dose, 30-count bottle, and prescription label. The product was manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India and distributed by Zydus Pharmaceuticals (USA) Inc.
Verify the product label shows 0.5 mg, 30-count, and prescription-only status.
The recall indicates the tablets may contain unsafe impurities, so patients should not take them without consulting their doctor.
The official recall notice does not specify a return or replacement process.
The product expires December 31, 2026, as indicated on the label.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0001-2026 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0001-2026 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
