HIGH

Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC...

Discoloration - Expansion of RES #97424

Quick Facts at a Glance

Recall Date
October 6, 2025
Hazard Level
HIGH
Brands
TAVABOROLE, Viona Pharmaceuticals Inc
Geographic Scope
1 states

Hazard Information

Discoloration - Expansion of RES #97424

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

Full Description

Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.. Generic: TAVABOROLE; Brand: TAVABOROLE. Reason: Discoloration - Expansion of RES #97424. Classification: Class II. Quantity: 13080 bottles. Distribution: USA Nationwide

View Original Recall on FDA - Drug Safety

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Product Classification

Product Details

Model Numbers
Lot#: T400819
T400820
Exp 4/30/26
T401969
Exp 9/30/26
UPC Codes
72578-102
72578-102-04
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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