What is Tavaborole Topical Solution 5% used for?

It is a prescription antifungal used to treat fungal nail infections. The recall relates to a discoloration issue rather than a failure of efficacy.

Why is Tavaborole Topical Solution 5% being recalled?

The recall is due to discoloration linked to Expansion of RES #97424, a Class II drug quality issue.

How many bottles are recalled?

13,080 bottles are included in this recall, distributed nationwide in the United States.

Who manufactured and distributed the recalled product?

Manufactured by Zydus Lifesciences Ltd. in India. Distributed by Viona Pharmaceuticals Inc. in Cranford, New Jersey.

What should I do if I have this product?

Stop using the product immediately and contact Viona Pharmaceuticals Inc. or your healthcare provider for guidance.

Is there a refund or replacement available?

Refund or replacement details are not specified in the recall notice. Contact Viona Pharmaceuticals for guidance.

Where can I find more recall information?

FDA recall enforcement page D-0016-2026 lists the recall details and status.

How do I know if my bottle is affected?

Check the NDC 72578-102-04 and model numbers on the bottle label or packaging. Ensure it matches the recalled batch.

Are there any health risks from the discoloration?

The recall note mentions a quality issue related to discoloration. It advises stopping use until guidance is obtained.

Who should I contact for questions?

Contact Viona Pharmaceuticals Inc. at their Cranford, NJ address listed in the recall notice.

HIGHOctober 6, 2025

Viona Pharmaceuticals Recalls 13,080 Tavaborole Topical Solution 5% Bottles (2025 Recall)

Viona Pharmaceuticals recalled 13,080 Tavaborole Topical Solution 5%, 10 mL bottles distributed nationwide in the United States. The recall covers Tavaborole Topical Solution 5%, Rx only, manufactured by Zydus Lifesciences Ltd. Discoloration linked to RES #97424 prompted the action. Consumers should stop using the product and contact Viona for guidance.

Quick Facts at a Glance

Recall Date: October 6, 2025
Hazard Level: HIGH
Brands: Zydus Lifesciences, Viona Pharmaceuticals
Category: Health & Personal Care
Sold At: Unknown
Geographic Scope: 1 states
At-Risk Groups: GENERAL

Hazard Information

Discoloration - Expansion of RES #97424

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact VIONA PHARMACEUTICALS INC or your healthcare provider for guidance. Notification method: Letter

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About This Product

Tavaborole Topical Solution 5% is a prescription antifungal treatment in a 10 mL bottle. It is used to treat fungal infections of the nails. The recalled product is distributed nationwide in the United States.

Why This Is Dangerous

Discoloration is identified as a manufacturing quality issue tied to RES #97424. The label indicates a potential defect in the product that could affect appearance or integrity.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Consumers must stop using the product until guidance is provided. The recall affects a limited number of bottles but requires action to avoid continuing use of a potentially defective product.

Practical Guidance

How to identify if yours is affected

Check NDC 72578-102-04 on the bottle label.
Look for model numbers T400819, T400820, or T401969.
Note the 10 mL bottle size and Rx only designation.

Where to find product info

Recall details can be found on the FDA enforcement page and through Viona Pharmaceuticals. Check the label for NDC and model numbers.

What timeline to expect

Remedy processing timelines were not specified. Expect guidance from the company within weeks.

If the manufacturer is unresponsive

File a complaint with the FDA if the company does not respond within a reasonable time frame.
Keep records of all communications and dates.

How to prevent similar issues

Always verify NDC and lot numbers when receiving prescription medications.
Ask pharmacists for documentation when receiving prescription products from unfamiliar manufacturers.
Monitor for recalls on prescription medications via the FDA recall site.

Documentation advice

Keep the product packaging, recall notice, and any correspondence with the company for future reference.

Product Details

Model numbers: T400819, T400820, T401969. NDC 72578-102-04. Rx only. Manufactured by Zydus Lifesciences Ltd., Changodar, Ahmedabad, India. Distributed by Viona Pharmaceuticals Inc., Cranford, NJ 07016. Quantity: 13,080 bottles. Distribution: USA nationwide. Recall date: 2025-10-06. Status: ACTIVE.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

13,080 bottles recalled
NDC 72578-102-04
Rx only Tavaborole Topical Solution 5% 10 mL
Manufactured in India by Zydus Lifesciences
Distributed nationwide in the USA

View Original Recall on FDA - Drug Safety

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Drugs & Medications

Product TypeTopical antifungal solution

Product Details

Brands

Zydus Lifesciences Viona Pharmaceuticals

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