HIGH

Zydus Pharmaceuticals Recalls Entecavir Tablets Over Impurity Risk

Zydus Pharmaceuticals recalled 4,440 bottles of Entecavir Tablets on September 4, 2025. The recall follows failure to meet impurity and degradation specifications. Consumers should stop using the affected tablets immediately and contact their healthcare provider.

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 recall affects Entecavir Tablets, USP, 1 mg, in 30-tablet bottles. The affected lot number is E309377, with an expiration date of November 30, 2025. The product was distributed nationwide in the United States.

The Hazard

The recall is due to failure to meet impurity and degradation specifications. This could potentially compromise the quality and efficacy of the medication.

Reported Incidents

There are no reported incidents of injury or adverse effects associated with this recall. The recall is conducted as a precautionary measure.

What to Do

Stop using the recalled Entecavir Tablets immediately. Contact Zydus Pharmaceuticals (USA) Inc. or your healthcare provider for guidance and further information.

Contact Information

For additional information, consumers can contact Zydus Pharmaceuticals at 1-XXX-XXX-XXXX or visit their website.

Key Facts

  • Recall date: September 4, 2025
  • Quantity recalled: 4,440 bottles
  • Lot number: E309377
  • 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 E309377
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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