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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Zydus Lifesciences, Viona Pharmaceuticals
- Product type
- Topical antifungal solution
- Model numbers
- T400819, T400820, T401969
- UPC codes
- 72578-102, 72578-102-04
- Sizes
- 10 mL
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 6, 2025
Reported by FDA DRUG
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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.
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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
- Rx only Tavaborole Topical Solution 5% 10 mL
- Manufactured in India by Zydus Lifesciences
- Distributed nationwide in the USA
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Safety Guide
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