Quick Facts at a Glance
- Recall Date
- August 12, 2025
- Hazard Level
- HIGH
- Brands
- TAVABOROLE, 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
- TAVABOROLE, Viona Pharmaceuticals
- Product type
- Topical Antifungal Solution
- Model numbers
- T401968
- 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
August 12, 2025
Reported by FDA DRUG
August 27, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Discoloration
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 used for fungal infections. It is supplied in glass bottles and distributed nationwide.
Why This Is Dangerous
Discoloration triggers the recall; the specific impact on safety beyond labeling is not provided in the notice.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
The recall affects patient trust and requires clinicians and pharmacies to review stock and substitutions. The immediate action is to stop use and consult the distributor.
Practical Guidance
How to identify if yours is affected
- Check NDC 72578-102-04 on the bottle
- Look for model T401968
- Verify packaging and labeling indicating Tavaborole Topical Solution 5%, 10 mL glass bottle
Where to find product info
NDC and model numbers on bottle, box, or accompanying labeling. Distributor communications will provide further instructions.
What timeline to expect
Refund or replacement processing times to be communicated by the distributor; expect several weeks for processing after submission.
If the manufacturer is unresponsive
- Contact your pharmacist or healthcare provider for guidance
- File a consumer safety complaint with the FDA if necessary
How to prevent similar issues
- Verify NDC and lot codes before dispensing any prescription medication
- Monitor for discoloration in bottled preparations and report immediately
- Ensure proper storage per label and pharmacy guidance
Documentation advice
Keep packaging, bottle, receipts, and recall notice. Document all communications with the distributor.
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Product Details
Product: Tavaborole Topical Solution 5%, 10 mL per glass bottle. Brand: Tavaborole. Generic: Tavaborole. NDC: 72578-102-04. Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. Quantity recalled: 3,960 bottles. Distribution: Nationwide in the USA. Recall date: 2025-08-12. Classification: Class II recall. Hazard: Discoloration.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 3,960 bottles recalled nationwide in the USA
- Class II recall, high hazard level
- Discoloration cited as the reason for recall
- Manufactured by Zydus Lifesciences Ltd., India
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Safety Guide
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