Dapsone Gel 7.5% recalled nationwide due to crystallization
Viona Pharmaceuticals is recalling Dapsone Gel 7.5% due to crystallization. The voluntary recall covers 6,048 pumps distributed nationwide in the United States.
What this means for you
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: Voluntary, firm-initiated precautionary recall with no reported illnesses or injuries. The crystallization is a formulation stability issue. FDA classified as Class II, which indicates potential for health problems but with no reported hospitalizations or harm.
Plain-English summary
Dapsone Gel 7.5% is a topical prescription medication being recalled by Viona Pharmaceuticals Inc. due to crystallization of the product. The medication is manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India, and distributed by Viona Pharmaceuticals from their facility in Cranford, New Jersey. The firm voluntarily initiated the recall on October 29, 2024, which was classified as Class II by the FDA on November 5, 2024.
The recall affects 6,048 pumps distributed nationwide throughout the United States. The affected product lot numbers are T401151 (expiration date June 30, 2026) and T400806 (expiration date March 31, 2026).
Patients who have this medication should consult with their healthcare provider or pharmacist regarding their prescriptions. These medical professionals can advise on whether the patient's supply is affected and recommend appropriate alternatives or next steps for treatment.
The recalled product
- Product
- DAPSONE (DAPSONE)
- Brand
- DAPSONE
- Manufacturer
- VIONA PHARMACEUTICALS INC
- Category
- Drug — Topical
- Hazard
- crystallization
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 (5)
- Lots T401151
- Exp
- 06/30/2026
- T400806
- Exp 03/31/2026
Distribution
Distributed nationwide across the United States.
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