Dapsone recalls

The FDA has published 4 recalls involving Dapsone since 2024. The latest was reported on 8 Jan 2025. Most were for packaging defects. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls4since 2024

Last 12 months0reported

Class I00% of total

Ongoing4latest 8 Jan 2025

Recalls per month, last 24 months

click a bar for that month

1Oct '24 1 0 2Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 4 100%Class III 0 0%

Why dapsone is recalled

Packaging Defects250%
Other Reasons250%

Companies

Viona Pharmaceuticals4100%

By year

2025250%
2024250%

Ongoing dapsone recalls

4 active

Reported	Class	Recall	Company	Reason	Where
8 Jan 2025Drug	CLASS II	Dapsone Gel recalled by Viona PharmaceuticalsDapsone	Viona Pharmaceuticals	Packaging Defects	Nationwide
8 Jan 2025Drug	CLASS II	Dapsone Gel recalled by Viona PharmaceuticalsDapsone	Viona Pharmaceuticals	Packaging Defects	Nationwide
13 Nov 2024Drug	CLASS II	Dapsone Gel 5% pump recalled by Viona PharmaceuticalsDapsone	Viona Pharmaceuticals	Other	Nationwide
23 Oct 2024Drug	CLASS II	Dapsone Gel 5% pump recalled by Viona PharmaceuticalsDapsone	Viona Pharmaceuticals	Other	NY

All dapsone recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
8 Jan 2025Drug	CLASS II	Dapsone Gel recalled by Viona PharmaceuticalsDapsone	Viona Pharmaceuticals	Packaging Defects	Nationwide
8 Jan 2025Drug	CLASS II	Dapsone Gel recalled by Viona PharmaceuticalsDapsone	Viona Pharmaceuticals	Packaging Defects	Nationwide
13 Nov 2024Drug	CLASS II	Dapsone Gel 5% pump recalled by Viona PharmaceuticalsDapsone	Viona Pharmaceuticals	Other	Nationwide
23 Oct 2024Drug	CLASS II	Dapsone Gel 5% pump recalled by Viona PharmaceuticalsDapsone	Viona Pharmaceuticals	Other	NY

Should you stop taking Dapsone?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.