Viona Dapsone Gel 7.5% Recall: Crystallization Risk
Viona Pharmaceuticals recalls Dapsone Gel 7.5% (60g pump) due to crystallization risk. This prescription medication may cause issues if stored improperly. Check NDC 72578-094-02 and lot T400512 for affected units.
Recall notice
Crystallization
Contact the company
What happened, in plain English
Viona Pharmaceuticals is recalling Dapsone Gel 7.5% (60g pump) because crystallization could cause problems. This is a prescription-only medication that may need special handling to avoid issues. Read more at govinfonow.com/recall/32535-viona-dapsone-gel-7-5-recall-crystallization-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32535-viona-dapsone-gel-7-5-recall-crystallization-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0011-2025
Cite this page
“Viona Dapsone Gel 7.5% Recall: Crystallization Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32535-viona-dapsone-gel-7-5-recall-crystallization-risk. Based on FDA recall #D-0011-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0011-2025%22&limit=1).
Why it’s dangerous
Crystallization in the gel could lead to changes in the medication's properties. This might affect how the drug works or causes issues if the product is not stored properly.
Who’s affected
Prescription patients using Dapsone Gel 7.5% (60g pump) with NDC 72578-094-02 and lot number T400512 are affected. Patients with this specific medication are most at risk.
How to tell if you have this one
Check for the NDC code 72578-094-02 and lot number T400512 on the product label. This Dapsone Gel 7.5% (60g pump) is only available through prescription.
- Brand
Viona Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for NDC 72578-094-02 and lot number T400512 on the label.
Where it went and when
Where it was distributed
Distributed in New York.
FDA distribution: “NY” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York.
Recall timeline
FDA published this recall 29 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0011-2025 (September 24, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0011-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.