Benzoyl Peroxide Acne Drugs: Limited Recalls Despite Evidence of Degradation Into Benzene

In March 2024, Valisure, a private, Connecticut-based laboratory, petitioned the Food and Drug Administration (FDA) to request a recall and suspension of sales of U.S. products that contain benzoyl peroxide (including ACANYA, BENZAMYCIN, CABTREO, DUAC, EPIDUO, EPSOLAY, ONEXTON, TWYNEO and generics).[1]

Commonly available in numerous over-the-counter and prescription topical formulations (including creams, gels, lotions and washes), benzoyl peroxide products are used to treat acne due to their bactericidal activity. Valisure’s petition was based on the laboratory’s own analyses showing that many benzoyl peroxide products contain high levels of benzene, a chemical known to cause leukemia and other blood cell cancers.

There has been additional evidence supporting Valisure’s findings. In March 2025, however, the FDA attributed the high levels of benzene to a handful of benzoyl peroxide products that had been recalled, leaving most of the remaining products on the U.S. market.

Valisure’s initial evidence

Valisure’s analysis involved samples from 99 benzoyl peroxide acne products and 76 acne products with other active ingredients (such as adapalene or salicylic acid). The petitioner purchased these products from major retailers and licensed pharmaceutical wholesalers.

Valisure scientists found that, at normal temperatures, 95% of the tested benzoyl peroxide products tested positive for benzene, often with values well above the FDA’s permissible limit for drug products (two parts per million [ppm]) for drugs “with significant therapeutic advance.”[2] In contrast, the other 76 tested acne products had either no detectable benzene or had levels that were below the FDA’s permissible limit.

Valisure reported that, when stored for two weeks at less than 122 degrees Fahrenheit, some benzoyl peroxide drugs formed benzene at levels that are 800 times higher than the FDA’s permissible limit. Moreover, the resulting benzene can leak outside of intact benzoyl peroxide containers into the surrounding air, creating a serious inhalation risk.

Importantly, the presence of benzene in benzoyl peroxide drugs does not appear to result from contamination during the manufacturing process, but from the breakdown of the active drug ingredient into benzene, according to Valisure.

Additional evidence

In October 2024 Valisure and researchers from Yale and Long Island Universities published an article online in the Journal of Investigative Dermatology with results of a new analysis of benzene levels in benzoyl peroxide products.[3],[4]

In response to criticism of the high temperatures used in the initial analysis, the new study tested benzoyl peroxide products at room temperature shortly after they were acquired from shelves, to resemble the conditions under which the products are used by consumers.

Of 111 tested benzoyl peroxide products, 38 (34%) contained benzene levels higher than the FDA’s permissible limit, with concentrations as high as 35 ppm in some of them. Overall, the study showed that exposure to sunlight and storage at room temperature can cause benzene formation. In contrast, refrigeration of these products may help reduce their degradation into benzene.

In August 2024 a Florida-based law firm (Aylstock, Witkin, Kreis & Overholtz) petitioned the FDA on behalf of some of its clients to recall and suspend sales of U.S. benzoyl peroxide products due to the presence of benzene.[5] This petition was based on testing of benzene levels in benzoyl peroxide products that had been purchased “off-the-shelf,” similar to the Valisure study.

The testing was done by a private laboratory (Eurofins Consumer Product Testing), and the products were not subjected to elevated temperatures. The petitioner listed 27 products from different manufacturers with benzene content ranging from 60 to 655 ppm but did not specify the total number of the tested products in the petition.

Limited product recalls

In March 2025 the FDA announced that it had initiated its own testing of benzene levels in benzoyl peroxide products.[6] Of 95 tested products, more than 90% had “undetectable and extremely low” levels of benzene, according to the FDA. Only six products had elevated benzene levels, and their manufacturers voluntarily agreed to recall them. The FDA indicated that some of the recalled products were approaching their expiration dates and recommended that consumers dispose of expired benzoyl peroxide products.

Despite the limited retail-level recalls, the FDA did not specifically instruct consumers to dispose of any unexpired benzoyl peroxide products they currently have. The FDA will publish the results of its testing at a later date.

As of August, three additional products have been recalled but the FDA has not yet decided on the petitions.

What You Can Do

If you are currently using benzoyl peroxide products, your risk is still relatively low because the cancer risk associated with use of these products requires prolonged exposure. Discuss other treatment options (such as those that contain salicylic acid, azelaic acid or topical retinoids) with your clinician.[7] Otherwise, it is best not to start benzoyl peroxide products until more conclusive information becomes available.
 

References

[1] Valisure. Valisure citizen petition on benzene in benzoyl peroxide drug products. March 5, 2024. https://assets-global.website-files.com/6215052733f8bb8fea016220/65e8560962ed23f744902a7b_Valisure%20Citizen%20Petition%20on%20Benzene%20in%20Benzoyl%20Peroxide%20Drug%20Products.pdf. Accessed July 1, 2025.

[2] Food and Drug Administration. Q3C — Tables and list: Guidance for industry (revision 4). August 2018. https://www.fda.gov/media/133650/download. Accessed July 1, 2025.

[3] Valisure. New Valisure scientific paper on benzene in benzoyl peroxide products. https://www.valisure.com/valisure-newsroom/new-valisure-scientific-paper-on-benzene-in-benzoyl-peroxide-products. Accessed July 2, 2025.

[4] Kucera K, Zenzola N, Hudspeth A, et al. Evaluation of benzene presence and formation in benzoyl peroxide drug products. J Invest Dermatol. 2025;145(5):1147-1154.e11.

[5] Aylstock, Witkin, Kreis & Overholtz, PLLC. Citizen petition regarding benzene content in benzoyl peroxide products. August 20, 2024. https://www.regulations.gov/document/FDA-2024-P-3997-0001. Accessed July 2, 2025.

[6] Food and Drug Administration. Limited number of voluntary recalls initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination. March 11, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/limited-number-voluntary-recalls-initiated-after-fda-testing-acne-products-benzene-findings-show. Accessed July 2, 2025.

[7] American Academy of Dermatology. American Academy of Dermatology statement on benzoyl peroxide in OTC personal care products. March 24, 2025. https://www.aad.org/news/benzoyl-peroxide-personal-care-products. Accessed July 2, 2025.