HIGH

Viona Pharmaceuticals Recalls Tavaborole Topical Solution Over Discoloration Hazard

Viona Pharmaceuticals recalled 3,960 bottles of Tavaborole Topical Solution on August 12, 2025. The product may show discoloration, posing health risks to consumers. This recall affects topical solutions distributed nationwide in the USA.

Quick Facts at a Glance

Recall Date
August 12, 2025
Hazard Level
HIGH
Brands
TAVABOROLE, Viona Pharmaceuticals
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Discoloration

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact VIONA PHARMACEUTICALS INC or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recalled product is Tavaborole Topical Solution 5%, packaged in 10 mL glass bottles. The NDC is 72578-102-04, and the lot number is T401968.

The Hazard

The discoloration of the Tavaborole Topical Solution may indicate chemical instability. This poses potential health risks to consumers using the product.

Reported Incidents

No specific incidents have been reported in connection with this recall. The recall is classified as Class II due to the potential health risks associated with the discoloration.

What to Do

Consumers should stop using the product immediately. Contact Viona Pharmaceuticals or a healthcare provider for further guidance.

Contact Information

For more information, contact Viona Pharmaceuticals Inc. at their Cranford, NJ office or visit their website.

Key Facts

  • Recall date: August 12, 2025
  • Quantity recalled: 3,960 bottles
  • Discoloration poses health risks
  • Stop using the product immediately
  • Contact Viona Pharmaceuticals for guidance

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Safety Assessment

Risk LevelHIGH
Severity Score
6/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
T401968
UPC Codes
72578-102
72578-102-04
Affected States
ALL
Report Date
August 27, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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