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Drug FDA Class II Ongoing Quality

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.

VIONA PHARMACEUTICALS INC Published Oct 22, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact VIONA PHARMACEUTICALS INC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Discoloration

Affected products (1)

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.

TAVABOROLE · 13080 bottles

NDC: 72578-102, 72578-102-04
Code info: Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26

Affected areas

Nationwide

Timeline

  1. Initiated
    Oct 6, 2025
  2. Published
    Oct 22, 2025
Recall number
D-0016-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.