Zydus Lifesciences Dapsone Gel Recalled by USFDA
New Delhi: Zydus Lifesciences Ltd has been implicated in a recall of 23,304 bottles of Dapsone Gel 7.5%, a popular acne treatment distributed under brands such as Nurx and Aczone. The recall, initiated by the United States Food and Drug Administration (USFDA), targets this topical antibiotic, widely prescribed for improving acne symptoms, with claims of visible relief within 12 weeks, according to a recent media report in The Economic Times.
The recall was prompted after samples of Dapsone Gel 7.5% were found to have crystallized. Although the FDA has not disclosed specific risks associated with crystallization, such issues can lead to incorrect dosing and potentially compromise the medication's safety and effectiveness.
On January 2, 2025, the FDA classified the recall as Class II, signifying that the product could cause temporary or reversible adverse health effects but is unlikely to result in severe harm. However, experts at the Cleveland Clinic warn that excessive use of dapsone gel could pose serious medical risks.
The recalled Dapsone Gel 7.5% was distributed by Viona Pharmaceuticals Inc., headquartered in Cranford, New Jersey. It was sold in 60-gram airless pump packs, identifiable by their white tubes with pink accents and black lettering.
Also Read: Zydus Lifesciences bags USFDA nod for Dapsone Gel for acne treatment
The affected products can be identified by the following details:
NDC: 72578-094-02
Lot Numbers and Expiration Dates:
Lot T400807, Exp Date 02/2026
Lot T401152, Exp Date 03/2026
Lot T401303, Exp Date 06/2026
Lot T401304, Exp Date 07/2026
Lot T401399, Exp Date 07/2026
Lot T401696, Exp Date 08/2026
Dapsone Gel 7.5% is FDA-approved for individuals aged nine years and older. It works by targeting bacteria on the skin that cause inflammation and breakouts. However, its use should always be guided by a licensed healthcare provider, reports ET.
Consumers in possession of affected lots are advised to stop using the product immediately and consult their healthcare provider to discuss alternatives or obtain a replacement. For more information, patients are encouraged to contact their healthcare provider or the product distributor directly.
