Medications & Supplements/Prescription Drugs

Entecavir Tablets Recalled for Impurity Specifications

Agency Publication Date: October 2, 2025

Summary

Zydus Pharmaceuticals (USA) Inc. is voluntarily recalling 1,512 bottles of Entecavir (entecavir), an antiviral medication used to treat chronic hepatitis B. The recall includes 912 bottles of 0.5 mg tablets and 600 bottles of 1 mg tablets because testing showed an organic impurity result that was outside of required safety specifications. This defect was discovered during stability testing and could mean the medication contains higher-than-allowed levels of degradation products.

Risk

The presence of an individual organic impurity above established limits may reduce the effectiveness of the drug or potentially expose patients to unknown risks from the degradation product.

What You Should Do

Check your medication bottles for Entecavir Tablets, USP, in 0.5 mg (NDC 68382-920-06) or 1 mg (NDC 68382-921-06) strengths.
Locate the lot number and expiration date on the bottle label. This recall specifically affects lot E409308 (Exp 12/31/2026) for the 0.5 mg strength and lot E409309 (Exp 12/31/2026) for the 1 mg strength.
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.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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-count bottle)

Variants: 0.5 mg strength, 30-count bottle, Rx Only

Lot Numbers:

E409308 (Exp 12/31/2026)

NDC:

68382-920-06

Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534

Product: Entecavir Tablets, USP (1 mg, 30-count bottle)

Variants: 1 mg strength, 30-count bottle, Rx Only

Lot Numbers:

E409309 (Exp 12/31/2026)

NDC:

68382-921-06

Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97684

Status: Active

Manufacturer: Zydus Pharmaceuticals (USA) Inc

Sold By: Retail Pharmacies

Manufactured In: India, United States

Units Affected: 2 products (912 30-count bottles; 600 30-count 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 · 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.

Summary

What You Should Do

Check your medication bottles for Entecavir Tablets, USP, in 0.5 mg (NDC 68382-920-06) or 1 mg (NDC 68382-921-06) strengths.

Locate the lot number and expiration date on the bottle label. This recall specifically affects lot E409308 (Exp 12/31/2026) for the 0.5 mg strength and lot E409309 (Exp 12/31/2026) for the 1 mg strength.

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.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 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

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-count bottle)

Variants: 0.5 mg strength, 30-count bottle, Rx Only

Lot Numbers:

E409308 (Exp 12/31/2026)

NDC:

68382-920-06

Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534

Product: Entecavir Tablets, USP (1 mg, 30-count bottle)

Variants: 1 mg strength, 30-count bottle, Rx Only

Lot Numbers:

E409309 (Exp 12/31/2026)

NDC:

68382-921-06

Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534