Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- VIONA PHARMACEUTICALS INC
- Reason for Recall:
- Discoloration
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Changodar, Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-102-04.
Product Codes/Lot Numbers:
Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0016-2026
Related Recalls
Class I - Dangerous
Discoloration
Class I - Dangerous
Crystallization
Class I - Dangerous
Crystallization