FDA Recalls Acne Products Due to Elevated Benzene Levels: Health Risks and Consumer Guidance

The FDA has issued voluntary recalls for several popular acne products after discovering elevated levels of benzene, a known carcinogen. Six products from well-known brands, including La Roche-Posay, Proactiv, SLMD, and Walgreen s, have been pulled from shelves following testing of 95 acne treatments. While officials state the cancer risk from these products is very low, the presence of benzene—which has been linked to leukemia and nervous system problems—has prompted manufacturers to remove affected products from retail locations. Consumers are left wondering which products are safe to use and what precautions to take.

FDA Testing Identifies Six Products with Elevated Benzene

The Food and Drug Administration recently tested 95 acne products containing benzoyl peroxide and found elevated levels of benzene in six of them. The affected products include La Roche-Posay Effaclar Duo, Proactiv Emergency Blemish Relief Cream, Proactiv Skin Smoothing Exfoliator, SLMD Benzoyl Peroxide Acne Lotion, Walgreens Acne Control Cleanser, and Walgreens Tinted Acne Treatment Cream. Additionally, Zapzyt Acne Treatment Gel was voluntarily recalled by its manufacturer after its testing revealed high benzene levels. The recalls are primarily at the retail level, meaning that stores remove products from shelves rather than asking consumers to return purchased items.

The FDA emphasized that over 90% of the tested products had undetectable or extremely low benzene levels, indicating that most acne treatments remain safe. Benzene is not an ingredient in these products but rather forms as a degradation product of benzoyl peroxide under certain conditions, including body temperature and elevated storage temperatures. The agency plans to publish its complete testing results in peer-reviewed journals to provide transparency about its findings and methodology.

Health Risks Associated with Benzene Exposure

Benzene is a natural chemical in crude oil, gasoline, and cigarette smoke. According to the American Cancer Society, exposure to benzene has been linked to increased cancer risk, particularly leukemia and other blood cell cancers. High exposure can also affect the nervous system, causing headaches, dizziness, and confusion. Despite these risks, the FDA has stated that the cancer risk from the recalled acne products is very low, as exposure from topical application is limited compared to industrial exposure or inhalation.

“The American Cancer Society states that exposure to benzene has been linked with a higher risk of cancer, particularly leukemia and other cancers of blood cells.”

Benzoyl peroxide, the active ingredient in the affected products, typically “works by decreasing inflammation and killing or preventing the growth of bacteria on your skin,” according to the Cleveland Clinic. The Journal of Investigative Dermatology has reported that benzene “is a known degradation product of benzoyl peroxide (BPO) and was recently reported to form when BPO drug products, used for acne and rosacea treatment, are incubated at body temperature and elevated temperatures expected during storage and transportation.”

Manufacturer Responses and Consumer Guidance

La Roche-Posay has responded proactively to the recall. A spokesperson stated: “While our Effaclar Duo Acne Spot Treatment has a long-standing history of safe and effective use, recent testing revealed minimal traces of benzene in one lot of the product. Although these trace levels do not pose a safety risk, we are committed to upholding the highest quality standards.” The company is removing the remaining units of the current formula and transitioning to a new and improved formula that will be available soon.

Consumers are advised to discard expired acne products, as benzene levels may increase over time. The FDA has not called for consumers to discard unexpired products they have already purchased, but instead focuses on removing potentially harmful products from retail locations. The agency encourages consumers to report adverse events or quality issues through its MedWatch program. The FDA has also cautioned against relying on results from third-party laboratories using unvalidated testing methods, which may produce inaccurate results and lead to unnecessary consumer confusion.

Sources:

https://people.com/carcinogen-found-in-acne-products-prompting-recall-11697357

https://www.fda.gov/drugs/drug-safety-and-availability/limited-number-voluntary-recalls-initiated-after-fda-testing-acne-products-benzene-findings-show

https://www.theepochtimes.com/health/fda-says-acne-products-recalled-over-carcinogenic-substance-5825505