Reported Oct 22, 2025 · Ongoing

Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad,…

Viona Pharmaceuticals Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: VIONA PHARMACEUTICALS INC · 20 Commerce Dr Ste 340 · Cranford, NJ · 07016-3617

Is this the product you have?

    • Tavaborole Topical solution 5%
    • 10 mL bottle
    • Rx only
  • Manufactured byZydus Lifesciences Ltd., Changodar, Ahmedabad, India
  • Distributed byViona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04
Lot codes and dates
    • Lot#: T400819
    • T400820
    • Exp 4/30/26
    • T401969
    • Exp 9/30/26
Amount recalled
13080 bottles

Where it was sold

  • Nationwide

Why it was recalled

Discoloration

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:06 PM UTC

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