Tavaborole Solution
FDA Recall NDC 72578-102
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Tavaborole (NDC 72578-102). A significant event, classified as Class II, was initiated on Oct 06, 2025 by Viona Pharmaceuticals Inc. The reported reason for this action was: "Discoloration"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Discoloration
Oct 06, 2025
Oct 22, 2025
13080 bottles
Recall Profile & Regulatory Data
Event ID
97756
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
VIONA PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Product 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.
Batch or Lot Expiration Information
Lot# : T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
Affected Packages Involved in this Recall
72578-102-04Product
Class II Ongoing
Discoloration
Aug 12, 2025
Aug 27, 2025
3960 bottles
Recall Profile & Regulatory Data
Event ID
97424
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
VIONA PHARMACEUTICALS INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Tavaborole Topical Solution 5%, 10 mL per glass bottle, Rx Only, For Topical Use Only, Manufactured by: Zydus Lifesciences Ltd., Changodar Ahmedabad, India. Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016. NDC: 72578-102-04
Batch or Lot Expiration Information
Lot# : T401968
Affected Packages Involved in this Recall
72578-102-04Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
