USFDA recalls 23,000 bottles of popular skincare product: Check brand, reason, and what to do if you have it
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Reason for Recall
The recall was triggered after samples of the product were found to have crystallized. While the FDA hasn’t detailed the specific risks in this case, crystallization in topical medications can lead to incorrect dosing and potentially diminish effectiveness or safety.
The FDA classified the recall as Class II on January 2, 2025, indicating that the product could cause temporary or reversible harm but is unlikely to result in serious illness or death. However, experts at the Cleveland Clinic caution that excessive use of dapsone gel can become a medical emergency.
Affected Product Details
The recalled Dapsone Gel 7.5% was distributed by Viona Pharmaceuticals Inc., based in Cranford, NJ, and manufactured by Zydus Lifesciences Ltd. in Ahmedabad, India.
The gel was sold in 60-gram airless pump packs with white tubes, pink accents, and black lettering. Consumers can identify the affected products by their National Drug Code (NDC) and lot codes:
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