FDA Recalls Six Popular Acne Products Due to Benzene Contamination

In March 2025, the U.S. Food and Drug Administration (FDA) issued voluntary recalls for several widely used acne treatments after tests revealed contamination with benzene, a chemical known to cause cancer. The recall stemmed from concerns raised by Valisure, an independent laboratory based in New Haven, Connecticut, which detected troubling levels of benzene in certain acne products containing benzoyl peroxide (BPO).

Benzoyl peroxide is a common active ingredient in acne medications, praised for its ability to eliminate bacteria associated with breakouts and reduce inflammation. However, researchers have long understood that BPO can break down into benzene over time, especially under certain storage conditions. Valisure's testing found that many products exceeded the FDA's safety limit of two parts per million (ppm) for benzene, with some products containing as much as 35 ppm.

The FDA's recall targeted products such as La Roche-Posay Effaclar Duo Dual Action Acne Treatment, Walgreens Acne Control Cleanser, Proactiv Benzoyl Peroxide 5% Relief Cream, and others. Dr. Christopher Bunick of Yale School of Medicine emphasized that no level of benzene should be present in these products, highlighting the health risks involved.

Benzoyl peroxide's effectiveness in treating acne is due to its bactericidal properties and possible anti-inflammatory effects. It is often combined with topical antibiotics to prevent antibiotic resistance. Despite its long history of use, benzoyl peroxide's chemical stability issues have been acknowledged since 1936, when chemist Hans Erlenmeyer identified its potential to form benzene.

Valisure's independent investigations have uncovered benzene contamination not only in acne treatments but also in other dermatological and consumer products like hand sanitizers and sunscreens. While low levels of benzene may seem insignificant, experts warn that the chemical's pervasive presence and cumulative exposure pose serious health risks, including increased likelihood of leukemia.

Following Valisure's findings, the FDA issued guidance in December 2023 recommending reformulation of certain drug products to reduce benzene levels. In 2024, further studies confirmed the presence of benzene in BPO products, revealing that this contamination results from the breakdown of BPO itself, not external contamination during manufacturing.

Critics have debated Valisure's testing methods and risk assessments, but the FDA's recall underscores the importance of independent testing in safeguarding public health. Experts advise consumers to use BPO products cautiously, avoiding storage in hot environments, and consulting dermatologists about safer alternatives.

The contamination issue highlights the need for ongoing surveillance and research to fully understand the long-term health impacts of benzene exposure from skincare products. Future epidemiological studies, such as those analyzing adverse event reports, suggest potential links between BPO products and risks of skin and breast cancer, reinforcing the call for stricter regulation and safer formulation practices.

Overall, these developments emphasize the importance of transparency, proper quality control, and consumer awareness when it comes to skincare products containing potentially harmful chemicals.