Reported Aug 27, 2025 · Ongoing

Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus…

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 per glass bottle, Rx Only, For Topical Use Only
  • Manufactured byZydus Lifesciences Ltd., Changodar Ahmedabad, India
  • Distributed byViona Pharmaceuticals Inc., Cranford, NJ 07016
  • NDC72578-102-04
Lot codes and dates
  • Lot #: T401968
Amount recalled
3960 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, 7:23 PM UTC

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