CLASS II ONGOING Drug recall · Reported 22 Oct 2025 · FDA Enforcement Report
Tavaborole Topical solution recalled by Viona Pharmaceuticals
Viona Pharmaceuticals is recalling Tavaborole Topical solution 5%, distributed nationwide in the US. The recall was initiated on 6 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0016-2026
- FDA event ID
- 97756
- Recalling firm
- Viona Pharmaceuticals, Cranford, NJ
- Brand
- Tavaborole
- Manufacturer
- Viona Pharmaceuticals Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Oct 2025
- FDA classified
- 10 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Creams, Ointments & Gels
Timeline
| 6 Oct 2025 | Recall initiated by company | |
| 10 Oct 2025 | Classified by FDA | +4 days |
| 22 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration
Product as listed by the FDA
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.
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Discoloration
Which lots are affected?
Lot#: T400819, T400820, Exp 4/30/26; T401969, Exp 9/30/26
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Viona Pharmaceuticals
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tavaborole Topical Solution recalled by Viona PharmaceuticalsTavaborole | Viona Pharmaceuticals | Foreign Material | Nationwide |
| Drug | CLASS II | Dapsone Gel recalled by Viona PharmaceuticalsDapsone | Viona Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Dapsone Gel recalled by Viona PharmaceuticalsDapsone | Viona Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Dapsone Gel 7.5% pump recalled by Viona PharmaceuticalsDapsone | Viona Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Dapsone Gel 7.5% pump recalled by Viona PharmaceuticalsDapsone | Viona Pharmaceuticals | Other | NY |
Other Tavaborole recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tavaborole Topical Solution recalled by Viona PharmaceuticalsTavaborole | Viona Pharmaceuticals | Foreign Material | Nationwide |