Medications & Supplements/Topical Products

Tavaborole Topical Solution Recalled for Discoloration

Agency Publication Date: October 10, 2025

Summary

Viona Pharmaceuticals Inc. is recalling 13,080 bottles of Tavaborole Topical Solution 5%, a prescription medication used to treat fungal nail infections. The recall was initiated because the solution showed signs of discoloration, which could indicate a change in the product's stability or quality. Consumers who have these bottles should check their packaging for specific lot numbers and expiration dates to see if their medication is affected.

Risk

The discoloration of the solution may indicate that the drug has degraded or changed chemically, which could potentially reduce the effectiveness of the treatment or cause unexpected side effects during application.

What You Should Do

Check your prescription bottle for the product name 'Tavaborole Topical solution 5%, 10 mL' and the NDC code 72578-102-04.
Look for the following affected lot numbers and expiration dates: Lot T400819 (Exp 4/30/26), Lot T400820 (Exp 4/30/26), and Lot T401969 (Exp 9/30/26).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tavaborole Topical solution 5% (10 mL bottle)by Viona Pharmaceuticals Inc.

Variants: Rx only

Lot Numbers:

T400819 (Exp 4/30/26)

T400820 (Exp 4/30/26)

T401969 (Exp 9/30/26)

NDC:

72578-102-04

Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India; Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97756

Status: Active

Manufacturer: VIONA PHARMACEUTICALS INC

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 13080 bottles

Distributed To: Nationwide

Agency Last Updated: November 6, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your prescription bottle for the product name 'Tavaborole Topical solution 5%, 10 mL' and the NDC code 72578-102-04.

Look for the following affected lot numbers and expiration dates: Lot T400819 (Exp 4/30/26), Lot T400820 (Exp 4/30/26), and Lot T401969 (Exp 9/30/26).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Tavaborole Topical solution 5% (10 mL bottle)by Viona Pharmaceuticals Inc.

Variants: Rx only

Lot Numbers:

T400819 (Exp 4/30/26)

T400820 (Exp 4/30/26)

T401969 (Exp 9/30/26)

NDC:

72578-102-04

Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India; Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016.