Viona Pharmaceuticals recalls Tavaborole 5% topical solution 10mL bottles due to discoloration. This may affect safety but does not cause injury. Check NDC 72578-102-04 and lot numbers for affected products.
“Viona Tavaborole 5% Solution Recall: Discoloration Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31754-viona-tavaborole-5-solution-recall-discoloration-hazard. Based on FDA recall #D-0016-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0016-2026%22&limit=1).
The FDA announced on Oct. 6, 2025, that Viona Pharmaceuticals Inc. is recalling Tavaborole Topical solution 5% due to discoloration hazards. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Viona Pharmaceuticals
Product: Tavaborole Topical solution 5%, 10 mL bottle
NDC: 72578-102-04
Lot codes: T400819, T400820 (Exp 4/30/26); T401969 (Exp 9/30/26)
The recall addresses discoloration in the Tavaborole Topical solution. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Viona Pharmaceuticals has issued six other recalls since June 1, 2021, including a Tavaborole recall on Aug. 12, 2025, and Dapsone Gel recalls on Dec. 10, 2024, and Oct. 29, 2024. Other recent recalls of similar products include Sun Pharmaceutical Fluocinolone Acetonide Solution (Dec. 30, 2025), CoValence Laboratories Blemish Spot Treatment (April 1, 2026), and Teva Clonidine Transdermal System (March 19, 2026).
How to tell if you have this one
Check for NDC 72578-102-04 and lot numbers T400819, T400820 (expiring 4/30/26) or T401969 (expiring 9/30/26). The product is a prescription-only topical solution for fungal infections.
Brand
Viona Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for NDC 72578-102-04 and lot numbers T400819, T400820 (expiring 4/30/26) or T401969 (expiring 9/30/26).
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 16 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0016-2026 (October 6, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0016-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.