Class Actions Against Acne Manufacturers Contain Benzene Contamination

Benzene Contamination Risk

Benzene is classified as a Group 1 carcinogen – so is asbestos and lead. Benzene gas was found in the airspace around products at around 1,270 times the threshold that the US Environmental Protection Agency has for long-term inhalation exposure to benzene. The FDA states that, even with daily use of the recalled benzoyl peroxide acne products for decades, the risk of a person developing cancer because of exposure to benzene found in these products is “very low”. But the agency doesn’t detail what ‘very low’ means, and ‘very low” doesn’t rule out that exposure to benzene can indeed cause cancer.

The FDA in March 2025 tested 95 acne products containing benzoyl peroxide after third-party testing results submitted to the agency raised concerns. More than 90% had undetectable or extremely low levels of benzene but six products had “problematic” levels of benzene. FDA said its testing results indicated fewer products with benzene contamination than the third-party findings.

In early 2024, independent testing laboratory Valisure (third party) detected concerning levels of benzene in dozens of popular acne products, such as Proactiv, Clinique, and Clearasil. Valisure found acne products that contain up to 12 times the allowed amount. It also found that the parts per million of benzene significantly increased when the acne products were tested at higher temperatures that were designed to replicate how the products can break down over time. And Dermatology Times said that high levels of benzene, which has been linked to cancer, were detected in numerous consumer acne products, including from major brands such as Proactiv, Clinique, and more.

Why Benzene in Acne Products

Benzene is an unintentional addition: it forms as a result of the breakdown of benzoyl peroxide, a common active ingredient in many acne treatments. Further, Benzene can be formed from benzoate under specific conditions, particularly when benzoate is combined with ascorbic acid (vitamin C) and exposed to heat or light. And Vitamin C is found in acne products due to its antioxidant and anti-inflammatory properties; it can help fade dark spots and hyperpigmentation; and helps regulate sebum (oil) production.

FDA Benzene Testing

Meanwhile, FDA said it is doing the following:

• Evaluating the root cause of benzene contamination. But the agency says Manufacturers should also be prepared to provide FDA with any information available on the potential source of the benzene to assist in FDA’s analysis.

• Alerted companies to the risk of benzene contamination in drug products. It goes on to say that makers who identify benzene in a drug product should also take steps to use ingredients without benzene, or, if justified, use suppliers that minimize risk of unacceptable benzene impurity levels. And herein we have a mixed message: It’s OK to use a small amount of benzene, but the FDA also says that manufacturers should not use benzene in the manufacture of drugs and that benzene is a known human carcinogen that causes leukemia and other blood disorders.

• Reminding companies of their obligation to ensure their products meet appropriate quality specifications. So, the acne products manufacturers are policing themselves.

• Continues to monitor the quality of drugs and, when appropriate, encourages retailers to remove products from store shelves and online marketplaces when issues arise.

Acne Benzene Recall

Manufacturers voluntarily agreed to recall the following six products due to elevated levels of benzene. Expiration dates are included because the FDA states that formation of benzene from benzoate can lead to an increase in benzene content over a drug’s shelf-life, meaning that older products could be more susceptible to benzene formation.

• La Roche-Posay Effaclar Duo Dual Action Acne Treatment (lot number MYX46W; expiration date, April 2025);
• Walgreens Acne Control Cleanser (lot number 23 09328; expiration date, September 2025);
• Proactiv Emergency Blemish Relief Cream Benzoyl Peroxide 5 percent (lot numbers V3305A and V3304A; expiration date, October 2025); Proactiv Skin Smoothing Exfoliator (lot number V4202A; expiration date, July 2025);
• SLMD Benzoyl Peroxide Acne Lotion (lot number 2430600; expiration date, March 2025);
• Walgreens Tinted Acne Treatment Cream (lot number 49707430; expiration date, March 2026).

Christopher Bunick, MD, PhD, associate professor of dermatology and physician-scientist at the Yale University School of Medicine, told Dermatology Times that “Millions of patients use over the counter or prescription acne products with benzoyl peroxide,” Bunick said. “Dermatologists will need to have serious discussions with their patients about the long-term safety risks of using these products having benzene.” 

Some patients may want to have serious discussions with lawyers nationwide who have filed numerous class action lawsuits against major acne product manufacturers over benzene contamination in benzoyl peroxide treatments.