CLASS II ONGOING Drug recall · Reported 27 Aug 2025 · FDA Enforcement Report
Tavaborole Topical Solution recalled by Viona Pharmaceuticals
Viona Pharmaceuticals is recalling Tavaborole Topical Solution 5% per, distributed nationwide in the US. The recall was initiated on 12 Aug 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-0595-2025
- FDA event ID
- 97424
- Recalling firm
- Viona Pharmaceuticals, Cranford, NJ
- Brand
- Tavaborole
- Manufacturer
- Viona Pharmaceuticals Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Aug 2025
- FDA classified
- 21 Aug 2025
- Reported
- 27 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Creams, Ointments & Gels
Timeline
| 12 Aug 2025 | Recall initiated by company | |
| 21 Aug 2025 | Classified by FDA | +9 days |
| 27 Aug 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Tavaborole Topical Solution 5% per recalled?
Yes. Viona Pharmaceuticals recalled Tavaborole Topical Solution 5% per on 12 Aug 2025. The recall is Class II and its status is Ongoing. Recall number D-0595-2025.
Why was it recalled?
Discoloration
Which lots are affected?
Lot #: T401968
Where was it sold?
Nationwide in the USA
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 21 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 | Other | 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 5% pump recalled by Viona PharmaceuticalsDapsone | Viona Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Dapsone Gel 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 | Other | Nationwide |