The U.S. Food and Drug Administration announced voluntary recalls of six popular acne products in March 2025 after testing revealed elevated levels of benzene, a known carcinogen, prompting safety concerns about widely used benzoyl peroxide treatments.
The FDA's action followed independent research by Valisure, a New Haven-based drug quality control laboratory, which discovered that benzoyl peroxide (BPO) can break down into benzene over time. The recalled products include La Roche-Posay Effaclar Duo Dual Action Acne Treatment, Walgreens Acne Control Cleanser, Proactiv Emergency Blemish Relief Cream, Proactiv Skin Smoothing Exfoliator, SLMD Benzoyl Peroxide Acne Lotion, and Walgreens Tinted Acne Treatment Cream.
FDA Testing Reveals Contamination Pattern
Of 95 acne products tested by the FDA, more than 90 percent showed undetectable or extremely low benzene levels. However, six products contained elevated levels that violated the conditional FDA limit of two parts per million (ppm). Some of the contaminated products were approaching their expiration dates, suggesting degradation over time contributes to benzene formation.
"There shouldn't be any carcinogens in any of our acne products," says Christopher Bunick, MD, PhD, associate professor of dermatology and translational biomedicine at Yale School of Medicine, who co-authored studies on benzene contamination. "The recall is a victory for patient safety."
Independent Research Uncovers Widespread Problem
Valisure's initial testing of 66 BPO-containing products found that many violated FDA limits, with some containing benzene levels as high as 35 ppm. The team published their findings in Environmental Health Perspectives in March 2024, followed by a study in the Journal of Investigative Dermatology in October 2024.
Unlike contamination from manufacturing processes seen in other products, benzene in acne medications stems from the breakdown of benzoyl peroxide itself. "When you expose the products to elevated temperatures, which simulates how they break down over time or under certain storage conditions, researchers discovered that they became contaminated with benzene," according to the research findings.
A follow-up study testing 111 products at room temperature found that one in three violated the FDA's conditional limit. "Every large store in America that has these products likely sells at least three benzoyl peroxide medications a day," Bunick notes. "That means at least one person per large store per day is walking out the door with a product containing a carcinogen level above the FDA regulatory limit."
Historical Context and Manufacturing Concerns
Benzoyl peroxide's instability has been recognized for decades. As early as 1936, German-Swiss chemist Hans Erlenmeyer described the breakdown of benzoyl peroxide into benzene. In 1997, manufacturing company AkzoNobel filed a patent for reducing benzene formation, indicating long-standing industry awareness of the issue.
Valisure has identified benzene contamination across multiple dermatological product categories, including hand sanitizers, sunscreens, aerosol sprays, and dry shampoos. "A lot of the precursors that go into forming these products actually are contaminated with benzene," Bunick explains. "A lot of these products become contaminated during the manufacturing process."
Health Implications and Risk Assessment
Epidemiological studies have shown that even trace levels of benzene can cause substantially increased risk of leukemia. The FDA notes that a person's risk for developing cancer from benzene exposure in these products is very low, even with decades of daily use. However, researchers emphasize the cumulative nature of benzene exposure from multiple sources.
"Benzene is in your acne products, it's in your dry shampoos, it's in your sunscreens, it's in second-hand or direct cigarette smoke, it's in exhaust from cars," Bunick explains. "It's all the benzene exposure throughout all of society that adds cumulative risk."
A recent pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database revealed that BPO-containing products were associated with greater odds of users reporting skin and breast cancer. While the study cannot establish causality, it provides signals warranting further investigation.
Consumer Guidance and Alternative Treatments
The recalls are being conducted at the retail level, with stores instructed to remove products from shelves. Consumers are not required to take action for products currently in their homes, other than disposing of expired products.
For those continuing to use BPO-containing products, researchers recommend using products before expiration dates and avoiding storage in hot environments such as showers or near heat radiators. "Don't panic. Benzoyl peroxide in most cases can still be used safely with proper precautions," says Fatemah Jafarian, MD, associate professor of dermatology at the University of Calgary.
Alternative acne treatments exist that do not involve benzoyl peroxide. Valisure's analyses of other acne products containing salicylic acid and adapalene found no benzene contamination, providing safer options for acne management.
The FDA stated its commitment to ensuring drug safety and will continue monitoring benzene issues in pharmaceutical products, communicating new information as it becomes available.
