Dapsone Gel Recalled Nationwide for Crystallization
Viona Pharmaceuticals is recalling Dapsone Gel 7.5% nationwide due to crystallization detected in multiple lots. Patients should contact their pharmacy or healthcare provider for guidance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II drug recall with no reported illnesses or injuries. The identified defect is crystallization, a product quality issue. The firm voluntarily initiated the recall. Per the severity rubric, this qualifies as Moderate because it represents a voluntary precautionary recall without reported harm.
Plain-English summary
Viona Pharmaceuticals Inc. is recalling Dapsone Gel 7.5% (60 g) distributed nationwide in the United States. The recall affects seven lots with expiration dates ranging from February 2026 to August 2026, totaling 23,304 packs.
The firm initiated this voluntary recall in response to crystallization detected in the product. The FDA classified this as a Class II recall.
Patients currently using affected lots should contact their pharmacy or healthcare provider for guidance on next steps. Do not discontinue use of the medication without consulting a healthcare professional.
The recalled product
- Product
- DAPSONE (DAPSONE)
- Brand
- DAPSONE
- Manufacturer
- VIONA PHARMACEUTICALS INC
- Category
- Drug — Topical
- Hazard
- Affected units
- 23,304
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- Lots T400513
- Exp Date 02/2026
- T400807
- Exp Date 03/2026
- T401152
- Exp Date 06/2026
- T401303
- Exp Date 07/2026
- T401304
- T401399
- Exp Date 07/2026 & T401696 Exp Date 08/2026.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by VIONA PHARMACEUTICALS INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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