Zydus Pharmaceuticals recalls 0.5mg Entecavir tablets due to failed impurity tests. This may cause health risks. Contact for return instructions.
Failed Impurity/Degradation Specifications
Zydus Pharmaceuticals is recalling 0.5 mg Entecavir tablets that failed impurity and degradation tests. This could pose health risks to patients taking the medication.
The tablets failed impurity and degradation specifications, meaning they may contain harmful substances or break down into unsafe compounds. This could lead to health issues for patients taking the medication.
Patients prescribed Entecavir tablets by a doctor are affected. Those with chronic hepatitis B who require this medication are at higher risk.
Check for the product name 'Entecavir Tablets, USP, 0.5 mg, 30 Tablets, Rx Only'. Look for the lot number E309376 and expiration date 11/30/2025 on the packaging.
Look for the lot number E309376 and expiration date 11/30/2025 on the packaging.
The tablets failed impurity and degradation specifications, which could pose health risks.
The recall record does not specify a remedy, so contact Zydus Pharmaceuticals for instructions.
The recall record does not describe a specific hazard mechanism that could cause serious injury.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0656-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0656-2025 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.