VIONA PHARMACEUTICALS INC recalls Dapsone Gel 7.5%, 90 g, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona
Viona Pharmaceuticals recalls Dapsone Gel 7.5% (90g) due to crystallization risk. This Rx-only medication, manufactured by Zydus Lifesciences, may cause issues if stored improperly.
Recall notice
Crystallization
Contact the company & request your remedy
What happened, in plain English
Viona Pharmaceuticals is recalling Dapsone Gel 7.5% (90g) because of a crystallization risk. This prescription-only medication could potentially cause problems if stored incorrectly. Read more at govinfonow.com/recall/32376-viona-dapsone-gel-7-5-recall-crystallization-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/32376-viona-dapsone-gel-7-5-recall-crystallization-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0172-2025
Cite this page
“Viona Dapsone Gel 7.5% Recall: Crystallization Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32376-viona-dapsone-gel-7-5-recall-crystallization-risk. Based on FDA recall #D-0172-2025 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0172-2025%22&limit=1).
Why it’s dangerous
Crystallization in the gel could lead to changes in the medication's consistency or effectiveness. This might 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% (90g) from Viona Pharmaceuticals. Those with the specific lot numbers T400514 or T400808 are most at risk.
How to tell if you have this one
Check for the product name 'Dapsone Gel 7.5% (90g)' with lot numbers T400514 (expiring 02/2026) or T400808 (expiring 03/2026).
- Brand
Viona- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide- NDC
72578-094-01, 72578-094-02, 72578-094-03
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0171-2025 | 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; Lots T400513, Exp Date 02/2026; T400807, Exp Date 03/2026; T401152, Exp Date 06/2026; T401303, Exp Date 07/2026; T401304, Exp Date 07/2026; T401399, Exp Date 07/2026 & T401696 Exp Date 08/2026. | 23304 packs |
| D-0172-2025 | 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; Lots T400514, Exp Date 02/2026 & T400808, Exp Date 03/2026 | 2760 packs |
What to do — step by step
Check Product Details
Look for the lot numbers T400514 or T400808 on the packaging.
Questions people ask
Is this product safe to use?
The recall does not specify if the product is safe to use; it mentions crystallization risk but does not detail the consequences.
What should I do if I have this product?
The recall record does not provide a remedy, so no specific action is required beyond checking the product details.
How can I tell if I have the recalled product?
Check for the lot numbers T400514 (expiring 02/2026) or T400808 (expiring 03/2026) on the packaging.
Contact Viona
We’ve drafted a message you can send Viona to request your refund or repair — edit it as you like.
Subject: Recall D-0172-2025 — Viona Viona Hello, I own a Viona that is covered by recall D-0172-2025 from Viona. 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-0172-2025 (December 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0172-2025 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.