Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Dapsone Gel 7.5%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Crystallization
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Dapsone Gel 7.5%, 60 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahemedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 72578-094-02. packaged in an Airless pump pack
Affected NDC
72578-0094-02
Compare with the code on your package — it is the most precise check available.
Drug: Dapsone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Dapsone NDC 72578-0094 |
75 mg/g | Gel Topical |
Viona Pharmaceuticals Inc | Rx |
- Recalling firm
- Viona Pharmaceuticals INC
- NDC code
- 72578-094-02
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0171-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Dapsone recalls
See all
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Dapsone active pharmaceutical ingredient packaged in varying grams or kg in bags or drums
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Other recalls by Viona Pharmaceuticals INC
All 2024 recalls
Class II · Moderate risk
Tavaborole Topical solution 5%
Discoloration
Class II · Moderate risk
Tavaborole Topical Solution 5%
Discoloration
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
Class II · Moderate risk
Dapsone Gel 7.5%
Crystallization
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