Dapsone Topical Gel Recalled Due to Crystallization Defect
Viona Pharmaceuticals is recalling Dapsone Gel 7.5% (2760 packs) distributed nationwide due to crystallization in the formulation. The voluntary recall affects lots T400514 and T400808.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is classified as an FDA Class II drug recall with no reported illnesses or injuries. The formulation defect poses a risk to proper medication delivery, qualifying it as High severity under the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Dapsone Gel 7.5% is a prescription topical medication. Viona Pharmaceuticals Inc. is recalling 2,760 packs of this product distributed nationwide due to crystallization in the gel formulation. The affected lots are T400514 (expiring February 2026) and T400808 (expiring March 2026).
Crystallization in the formulation may affect the consistency and delivery of the medication. The manufacturer initiated a voluntary recall on December 10, 2024, in response to this defect. This is classified as an FDA Class II recall.
Patients currently using this medication should contact their pharmacy or healthcare provider to determine if their supply is affected. The product was manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India, and distributed by Viona Pharmaceuticals Inc. in Cranford, New Jersey. The FDA's Drug Recall database provides additional information on this ongoing recall.
The recalled product
- Product
- DAPSONE (DAPSONE)
- Brand
- DAPSONE
- Manufacturer
- VIONA PHARMACEUTICALS INC
- Category
- Drug — Topical Dermatological
- Hazard
- crystallization
- formulation-defect
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 (3)
- Lots T400514
- Exp Date 02/2026 & T400808
- Exp Date 03/2026
Distribution
Distributed nationwide across the United States.
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FDA (Drugs) · 2024-11-13
- ModeratePrescription Dapsone Gel 7.5% Recalled Due to Crystallization
FDA (Drugs) · 2024-10-23
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