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.
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