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Class II: temporary or reversible health riskOngoing

Viona Pharmaceuticals Tavaborole Topical solution 5% Recall

Tavaborole Topical solution 5%, 10 mL bottle, Rx only, Manufactured by: Zydus Lifescien…

VIONA PHARMACEUTICALS INC · Cranford, NJ

Risk level
Class II
Reported by FDA
Oct 22, 2025
Recall ID
D-0016-2026
Check your lot numberHow we source this data

Summary

Viona Pharmaceuticals recalled Tavaborole Topical solution 5% starting Oct 6, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0016-2026 on Oct 22, 2025. Reason: Discoloration. Status: Ongoing.

Why it was recalled

Discoloration

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.

Lot numbers, UPCs & expiration codes

Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26

Where it was sold

USA Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0016-2026
Classification
Class II
Status
Ongoing
Recall initiated
Oct 6, 2025
FDA report date
Oct 22, 2025
Quantity
13080 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
VIONA PHARMACEUTICALS INC

Original FDA data

Every field from FDA enforcement report D-0016-2026, exactly as published.

Show all FDA fields
City
Cranford
State
NJ
Status
Ongoing
Country
United States
Event ID
97756
Address
20 Commerce Dr Ste 340
Code information
Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
Postal code
07016-3617
Report date
Oct 22, 2025
Product type
Drugs
Recall number
D-0016-2026
Classification
Class II
Recalling firm
VIONA PHARMACEUTICALS INC
Product quantity
13080 bottles
Reason for recall
Discoloration
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
USA Nationwide
Recall initiation date
Oct 6, 2025
Initial firm notification
Letter
Center classification date
Oct 10, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0016-2026, published Oct 22, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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