Prescription Dapsone Gel 7.5% Recalled Due to Crystallization
Viona Pharmaceuticals has voluntarily recalled 2,544 pumps of Dapsone Gel 7.5% (Lot #T400512) due to crystallization. The affected product was distributed in New York.
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 voluntary, firm-initiated Class II recall with no reported illnesses or injuries. Crystallization is a quality and stability concern rather than a direct contamination or safety hazard, consistent with precautionary recalls.
Plain-English summary
Dapsone Gel 7.5% manufactured by Zydus Lifesciences Ltd. and distributed by Viona Pharmaceuticals Inc. has been voluntarily recalled due to crystallization.
The affected product includes 2,544 pump dispensers of Lot #T400512 (expiration date 02/28/2026) distributed in New York. The FDA classified this as a Class II recall initiated by the firm on September 24, 2024.
Consumers with the affected lot should stop using the product and contact their pharmacist or healthcare provider for guidance. No illnesses or injuries related to this product have been reported.
The recalled product
- Product
- DAPSONE (DAPSONE)
- Brand
- DAPSONE
- Manufacturer
- VIONA PHARMACEUTICALS INC
- Category
- Drug — Topical
- Hazard
- Affected units
- 2,544
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 (2)
- Lot #: T400512
- Exp 02/28/2026
Distribution
Distributed in 1 state:
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