Addressing Ongoing Benzoyl Peroxide and Benzene Updates at AAD 2025

“We have benzoyl peroxide products that are forming benzene, some of them at levels above the conditional limit and are not lasting to the point of the expiration date on the product. This is a regulatory problem. These products are not in line with the FDA regulatory standard, and this is an opportunity for innovation in dermatology,” said Christopher Bunick, MD, PhD, in an interview at the 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

Bunick, associate professor of dermatology and translational biomedicine at Yale School of Medicine in New Haven, Connecticut, and Dermatology Times’ Editor in Chief, presented “Benzene in Benzoyl Peroxide Treatment in Acne & Rosacea” at the annual meeting.

As one of the researchers who has evaluated benzene concerns in benzoyl peroxide products since the first March 2024 reports,¹ Bunick emphasized the need for practical approaches to benzoyl peroxide use as clinicians and patients await regulatory action.

Benzoyl peroxide is a well-established treatment for acne, however, previous research published in the Journal of Investigative Dermatology found that one-third of room temperature tested products exceeded the FDA’s conditional benzene limit of 2 parts per million.² The FDA only permits this level when essential for a significant therapeutic advance, which does not necessarily apply to benzoyl peroxide given the availability of alternative acne treatments, according to Bunick.

He also highlighted that benzoyl peroxide products undergo stability testing, including accelerated stability testing, to ensure compliance with expiration dates. However, at elevated temperatures, certain formulations degraded into benzene at levels exceeding regulatory limits, indicating potential non-compliance with FDA expiration date standards.

Bunick emphasized that this issue presents an opportunity for innovation in dermatology, particularly in developing more stable formulations of benzoyl peroxide. In his talk, he shared practical steps for clinicians, including findings that refrigerating encapsulated benzoyl peroxide products reduced benzene formation. Based on this, he advises patients to store benzoyl peroxide products in the refrigerator rather than exposing them to heat, such as in cars or warm home environments.

During the annual AAD meeting, L’Oréal announced on March 10 that it is recalling all lots of its benzoyl peroxide-containing Effaclar Duo products in the US, sold under the La Roche-Posay brand name, due to benzene concerns.

“We have just heard that some benzoyl peroxide-containing products have been recalled from the market. What does this mean? This simply means that companies are doing their due diligence to try to protect the public patients, as they should,” Bunick told Dermatology Times at AAD.

Regarding the L’Oréal recall, Bunick’s key message to clinicians is that recalls stem from findings that benzoyl peroxide can degrade into benzene, a known carcinogen. While the full extent of health risks remains unclear and no direct causative link has been established, the recalls highlight a need for greater formulation stability in benzoyl peroxide products.

As the dermatology community awaits further FDA guidance, Bunick reiterated the importance of addressing these regulatory gaps to ensure benzoyl peroxide formulations remain both safe and effective for long-term clinical use.

References

1. Valisure detects benzene in benzoyl peroxide. News release. Valisure. March 6, 2024. Accessed March 11, 2025. https://www.valisure.com/valisure-newsroom/valisure-detects-benzene-in-benzoyl-peroxide
2. Kucera K, Zenzola N, Hudspeth A, et al. Evaluation of benzene presence and formation in benzoyl peroxide drug products. J Invest Dermatol. 2024 Oct 7. doi:10.1016/j.jid.2024.09.009