HIGH

Zydus Pharmaceuticals Recalls Entecavir Tablets Over Impurity Risk

Zydus Pharmaceuticals recalled 912 bottles of Entecavir Tablets on September 24, 2025, due to failed impurity specifications. The recall affects 30-count bottles of 0.5 mg tablets Distributed nationwide in the USA.

Quick Facts at a Glance

Recall Date
September 24, 2025
Hazard Level
HIGH
Brands
ENTECAVIR, Zydus Pharmaceuticals USA Inc.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity

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: Letter

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Product Details

The recalled product is Entecavir Tablets, USP, 0.5 mg, sold in 30-count bottles. The lot number is E409308 with an expiration date of December 31, 2026.

The Hazard

The recall stems from an out-of-specification result for an individual organic impurity. This could pose serious health risks to consumers.

Reported Incidents

No injuries or adverse events have been reported at this time. The FDA classified this recall as Class II due to the potential health risk.

What to Do

Consumers should stop using Entecavir Tablets immediately. Contact Zydus Pharmaceuticals or your healthcare provider for guidance.

Contact Information

For more information, call Zydus Pharmaceuticals at 1-800-XXX-XXXX. Visit their website or the FDA link for further details.

Key Facts

  • 912 bottles recalled
  • Distributed nationwide
  • Class II recall due to impurity issues
  • Stop using immediately
  • Contact healthcare provider for guidance

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Safety Assessment

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

Product Details

Model Numbers
Lot#: E409308
Exp 12/31/2026
UPC Codes
68382-920
68382-921
68382-920-06
+9 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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