VIONA PHARMACEUTICALS INC recalls Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by:
Viona Pharmaceuticals recalls Dapsone Gel 7.5% (60g pump) due to crystallization risk. Affected lots expire June 2026 or March 2026. Stop using immediately if you have this medication.
Recall notice
Crystallization
Contact the company & request your remedy
What happened, in plain English
Viona Pharmaceuticals is recalling Dapsone Gel 7.5% (60g pump) because it may crystallize, which could cause problems. This is a prescription-only medication that was manufactured in India and distributed in the U.S. The recall affects specific batches with expiration dates in 2026. Read more at govinfonow.com/recall/32481-viona-dapsone-gel-7-5-recall-crystallization-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32481-viona-dapsone-gel-7-5-recall-crystallization-risk · Updated September 23, 2026 · FDA enforcement record: FDA #D-0038-2025
Cite this page
“Viona Dapsone Gel 7.5% Recall: Crystallization Risk.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/32481-viona-dapsone-gel-7-5-recall-crystallization-risk. Based on FDA recall #D-0038-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0038-2025%22&limit=1).
Why it’s dangerous
Crystallization in the gel could lead to changes in the medication's consistency or effectiveness. This might cause issues with how the drug is absorbed by the body or could potentially cause physical discomfort or injury if the gel becomes too thick or separates.
Who’s affected
Prescription patients who have the Dapsone Gel 7.5% (60g pump) with lot numbers T401151 (expires June 30, 2026) or T400806 (expires March 31, 2026). Patients using this medication for conditions like leprosy or certain skin infections are most at risk.
How to tell if you have this one
Check the product label for the lot number: T401151 (expires June 30, 2026) or T400806 (expires March 31, 2026). This medication is a prescription-only gel used for specific medical conditions.
- Brand
Viona Pharmaceuticals- Category
Drug
What to do — step by step
Stop Using Immediately
If you have the recalled Dapsone Gel 7.5% (60g pump) with lot numbers T401151 or T400806, stop using it right away.
Questions people ask
Is this medication safe to use?
The recall is due to a potential crystallization issue, which could affect the medication's consistency. Do not use the recalled batches until you get a replacement.
What should I do if I have the recalled product?
Stop using it immediately and contact your doctor or pharmacist for guidance on alternatives.
How can I check if I have the recalled product?
Look for the lot numbers T401151 (expires June 30, 2026) or T400806 (expires March 31, 2026) on the product label.
Contact Viona Pharmaceuticals
We’ve drafted a message you can send Viona Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0038-2025 — Viona Pharmaceuticals Viona Pharmaceuticals Hello, I own a Viona Pharmaceuticals that is covered by recall D-0038-2025 from Viona Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0038-2025 (October 29, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0038-2025 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.