Zydus Pharmaceuticals recalls 1 mg Entecavir tablets due to failed impurity specifications. Patients should contact their doctor for guidance on safe use.
Failed Impurity/Degradation Specifications
Zydus Pharmaceuticals is recalling 1 mg Entecavir tablets that may have failed impurity or degradation tests. This could pose a risk to patients taking the medication.
The tablets may contain impurities or degrade during storage, potentially causing harm to patients. This risk is specific to the medication's quality control.
Patients prescribed Entecavir tablets by a doctor are affected. Those with liver conditions or on long-term treatment may be at higher risk.
Check for the product name 'Entecavir Tablets, USP, 1 mg, 30 Tablets, Rx Only' with NDC 68382-921-06. The lot number E309377 was manufactured in India and expires November 30, 2025.
Your healthcare provider can advise on whether to stop using the medication and alternative options.
No, only specific batches with NDC 68382-921-06 and lot E309377 are affected.
Look for the NDC code 68382-921-06 and lot number E309377 on the packaging.
The recall does not require immediate discontinuation; consult your doctor for guidance.
We’ve drafted a message you can send Zydus Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0657-2025 — Zydus Pharmaceuticals Zydus Pharmaceuticals Hello, I own a Zydus Pharmaceuticals that is covered by recall D-0657-2025 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.
