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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Entecavir Tablets Recalled for Failed Impurity and Degradation Specs

Agency Publication Date: September 18, 2025
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Summary

Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling 8,784 bottles of Entecavir (entecavir), a prescription medication used to treat chronic hepatitis B. The recall was initiated because the tablets failed to meet required specifications for impurities and degradation during testing. Consumers who have these tablets should contact their healthcare provider or pharmacist regarding their treatment.

Risk

The presence of impurities or degradation products beyond approved limits may reduce the effectiveness of the medication or cause unexpected side effects over time.

What You Should Do

  1. Check your medication bottles for Entecavir Tablets, USP in 0.5 mg or 1 mg strengths. Specifically, look for Lot E309376 (0.5 mg) or Lot E309377 (1 mg), both with an expiration date of 11/30/2025.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Entecavir Tablets, USP, 0.5 mg (30 Tablets)
Variants: 0.5 mg, Tablet
Lot Numbers:
E309376 (Exp 11/30/2025)
NDC:
68382-920-06

Recall #: D-0656-2025; Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

Product: Entecavir Tablets, USP, 1 mg (30 Tablets)
Variants: 1 mg, Tablet
Lot Numbers:
E309377 (Exp 11/30/2025)
NDC:
68382-921-06

Recall #: D-0657-2025; Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97556
Status: Active
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Sold By: Pharmacies
Manufactured In: India, United States
Units Affected: 2 products (4344 bottles; 4440 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.