Dapsone Gel 7.5% recall
FDA recall D-0172-2025 · initiated Dec 10, 2024
VIONA PHARMACEUTICALS INC recalled Dapsone Gel 7.5% in Dec 2024 — an FDA Class II recall (D-0172-2025) because Crystallization.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Crystallization
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2760 packs
Details
- Product
- Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-03. packaged in an Airless pump pack
- Recalling company
- VIONA PHARMACEUTICALS INC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide
- Initiated
- Dec 10, 2024
- FDA report date
- Jan 8, 2025
Frequently asked
- Was Dapsone Gel 7.5% recalled?
- VIONA PHARMACEUTICALS INC recalled Dapsone Gel 7.5% in Dec 2024 — an FDA Class II recall (D-0172-2025) because Crystallization. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Dapsone Gel 7.5% recalled?
- Per the FDA enforcement record, the reason for recall D-0172-2025 was: Crystallization
- Is a recalled Dapsone Gel 7.5% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Dapsone Gel 7.5% are affected?
- Distributed: US Nationwide. The recall covers these lots — Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0172-2025.