CLASS II ONGOING Drug recall · Reported 8 Jan 2025 · FDA Enforcement Report
Dapsone Gel recalled by Viona Pharmaceuticals
Viona Pharmaceuticals is recalling Dapsone Gel 7.5%, distributed nationwide in the US. The recall was initiated on 10 Dec 2024 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-0171-2025
- FDA event ID
- 95930
- Recalling firm
- Viona Pharmaceuticals, Cranford, NJ
- Brand
- Dapsone
- Manufacturer
- Viona Pharmaceuticals Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Dec 2024
- FDA classified
- 2 Jan 2025
- Reported
- 8 Jan 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 10 Dec 2024 | Recall initiated by company | |
| 2 Jan 2025 | Classified by FDA | +23 days |
| 8 Jan 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
Crystallization
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Crystallization
Which lots are affected?
Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026.
Where was it sold?
US 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.
Other products in this recall event
1 other product · FDA event 95930This product is part of a recall event; the main page for the event is Dapsone Gel recalled by Viona Pharmaceuticals.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Dapsone Gel recalled by Viona PharmaceuticalsDapsone | Viona Pharmaceuticals | Packaging Defects | Nationwide |
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 | 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 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 Dapsone recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |