Tavaborole Topical solution 5% recall
FDA recall D-0016-2026 · initiated Oct 6, 2025
VIONA PHARMACEUTICALS INC recalled Tavaborole Topical solution 5% in Oct 2025 — an FDA Class II recall (D-0016-2026) because Discoloration.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Discoloration
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 13080 bottles
Details
- Product
- 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.
- Recalling company
- VIONA PHARMACEUTICALS INC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Oct 6, 2025
- FDA report date
- Oct 22, 2025
Frequently asked
- Was Tavaborole Topical solution 5% recalled?
- VIONA PHARMACEUTICALS INC recalled Tavaborole Topical solution 5% in Oct 2025 — an FDA Class II recall (D-0016-2026) because Discoloration. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Tavaborole Topical solution 5% recalled?
- Per the FDA enforcement record, the reason for recall D-0016-2026 was: Discoloration
- Is a recalled Tavaborole Topical solution 5% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Tavaborole Topical solution 5% are affected?
- Distributed: USA Nationwide. The recall covers these lots — Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0016-2026.