HIGH

Zydus Pharmaceuticals Recalls Entecavir Tablets Due to Impurity Issues

Zydus Pharmaceuticals recalled 4,344 bottles of Entecavir Tablets on September 4, 2025. The recall stems from failed impurity and degradation specifications. Consumers should stop using the product immediately.

Quick Facts at a Glance

Recall Date
September 4, 2025
Hazard Level
HIGH
Brands
Zydus Pharmaceuticals USA Inc., Entecavir
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Failed Impurity/Degradation Specifications

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Zydus Pharmaceuticals (USA) Inc or your healthcare provider for guidance. Notification method: N/A

Product Details

The recalled product is Entecavir Tablets, USP, 0.5 mg, packaged in bottles of 30 tablets. The affected lot number is E309376, with an expiration date of November 30, 2025. These tablets were distributed nationwide across the United States.

The Hazard

The recall is classified as Class II due to failed impurity and degradation specifications. This means the product may cause temporary or medically reversible adverse health consequences.

Reported Incidents

There have been no reported injuries or incidents associated with the use of these tablets at this time.

What to Do

Consumers and healthcare providers should stop using Entecavir Tablets immediately. For guidance, contact Zydus Pharmaceuticals (USA) Inc. or consult a healthcare provider.

Contact Information

For more information, call Zydus Pharmaceuticals at 1-800-XXX-XXXX or visit their website at www.zydususa.com.

Key Facts

  • Recall date: September 4, 2025
  • Quantity recalled: 4,344 bottles
  • Manufacturer: Zydus Lifesciences Ltd.
  • Distribution: U.S. Nationwide
  • Expiration date: November 30, 2025

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot E309376
Exp 11/30/2025
UPC Codes
68382-920
68382-921
68382-920-06
+9 more
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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