Lower risk Drug recall · FDA · Published August 12, 2025

Viona Tavaborole 5% Solution Recall: Discoloration Hazard

Viona Pharmaceuticals recalls Tavaborole Topical Solution 5% 10mL glass bottles due to discoloration. This may affect medication appearance but does not pose a safety risk.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0595-2025Drug Viona Pharmaceuticals ›

Lower-risk recall

Discoloration

Take action

Contact the company

Recalling firmVIONA PHARMACEUTICALS INC20 Commerce Dr Ste 340 · Cranford, NJ 07016-3617

✎ GovInfoNow plain-language explainer

Viona Pharmaceuticals is recalling Tavaborole Topical Solution 5% 10mL glass bottles because they may discolor. This discoloration does not pose a safety risk to users. Read more at govinfonow.com/recall/31874-viona-tavaborole-5-solution-recall-discoloration-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/31874-viona-tavaborole-5-solution-recall-discoloration-hazard · Updated August 17, 2026 · FDA enforcement record: FDA #D-0595-2025

Cite this page

“Viona Tavaborole 5% Solution Recall: Discoloration Hazard.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/31874-viona-tavaborole-5-solution-recall-discoloration-hazard. Based on FDA recall #D-0595-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0595-2025%22&limit=1).

The FDA announced on 2025-08-12 that Viona Pharmaceuticals Inc. is voluntarily 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%
Size: 10 mL per glass bottle
NDC: 72578-102-04
Lot #: T401968
Manufacturer: Zydus Lifesciences Ltd.
Distributor: Viona Pharmaceuticals Inc., Cranford, NJ
Distribution: Nationwide in the USA
Units affected: 3960 bottles

The hazard

The recalled Tavaborole Topical Solution 5% presents a discoloration hazard. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Viona Pharmaceuticals Inc. has had six other recalls on record since 2021-06-01, including Tavaborole 5% Solution recalled for discoloration on 2025-10-06 and Dapsone Gel 7.5% recalled for crystallization hazards on 2024-12-10 and 2024-10-29. Other recent recalls of similar products include Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (2025-12-30), CoValence Laboratories Blemish Spot Treatment 1% Salicylic Acid Recall (2026-04-01), and Hetero Labs Pantoprazole Tablets Recall (2026-03-26).

How to tell if you have this one

Check for Tavabor: 5% Topical Solution 10mL glass bottles with NDC 72578-102-04 and lot number T401968. The product is prescription-only and distributed by Viona Pharmaceuticals.

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 number T401968 on the bottle label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 15 days after the firm started it.

Aug 12, 2025Firm started the recall
Aug 21, 2025FDA classified it Class II
Aug 27, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product dangerous?

No, discoloration does not pose a safety risk. The product is safe to use if it appears normal.

Do I need to stop using this product?

No, you do not need to stop using it. The discoloration is not a safety hazard.

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Link to this recall

<a href="https://govinfonow.com/recall/31874-viona-tavaborole-5-solution-recall-discoloration-hazard">Viona Tavaborole 5% Solution Recall: Discoloration Hazard (GovInfoNow)</a>

Where this comes from

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-0595-2025 (August 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0595-2025 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.