FDA Says Acne Products Recalled Over Carcinogenic Substance

The agency said it tested six products and found elevated levels of benzene, a chemical used in industrial processes.

The headquarters of the U.S. Food and Drug Administration (FDA) in Silver Spring, Md., on Nov. 4, 2009. Jason Reed/Reuters

The U.S. Food and Drug Administration (FDA) this week said that voluntary recalls for acne products have been initiated after the agency tested them and found benzene, a carcinogenic substance.

In a statement Tuesday, the FDA said that 95 acne products that contain benzoyl peroxide were tested and that a “limited number of products should be recalled at the retail level.” However, more than 90 percent of the products were tested to have “undetectable or extremely low levels of benzene,” the agency said.

The FDA listed six products that had elevated levels of benzene, including: La Roche-Posay Effaclar Duo Dual Action Acne Treatment, lot number MYX46W and expiration date of April 2025; Walgreens Acne Control Cleanser, lot number 23 09328 and expiration date of September 2025; Proactiv Emergency Blemish Relief Cream Benzoyl Peroxide 5%, lot numbersV3305A and V3304A with an expiration of October 2025; Proactiv Skin Smoothing Exfoliator, lot number V4204A with an expiration of July 2025; SLMD Benzoyl Peroxide Acne Lotion, lot number 2430600 with an expiration of March 2025; and Walgreens Tinted Acne Treatment Cream, lot number 49707430 with an expiration of March 2026.

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The FDA statement added that the maker of another acne product with benzoyl peroxide, Zapzyt Acne Treatment Gel, confirmed it would voluntarily recall its product “due to the elevated level of benzene found during its own testing.”

The federal health agency said that the recall was done at the retailer level and does not impact consumers. It means that stores that carry those products should remove them from their shelves, either online or in person.

Consumers who have such products that have approached their expiration dates should throw them away if they have expired, according to the FDA statement. However, the FDA noted that the risk of developing cancer through exposure to benzene in the products remains very low, even if they have used them “for decades.”

“FDA has continued to raise concern that use of unvalidated testing methods by third-party laboratories can produce inaccurate results leading to consumer confusion,” the statement said. “Specifically, such methods may result in much higher reported levels of contaminants such as benzene than are actually present in tested products. It is critical that third-party laboratories reporting their results to consumers use validated methods so their results are reliable.”

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As for benzene, federal officials say there is no safe level for human exposure to the chemical. Other officials have said it is frequently used in manufacturing to produce lubricants, dyes, plastics, resins, and fibers, while it is also found in consumer products such as gasoline, glues, paint thinners, and glues. Tobacco smoke is considered a major source of benzene exposure, health officials in Wisconsin also said.

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

“Rates of leukemia, particularly acute myeloid leukemia, have been found to be higher in studies of workers exposed to high levels of benzene, such as those in the chemical, shoemaking, and oil refining industries,” the group says on its website, adding that childhood forms of leukemia and other blood-related cancers have been linked to the chemical.

Aside from cancer, exposure to high levels of benzene can impact the human nervous system, including headaches, dizziness, confusion, tremors, and unconsciousness, according to the cancer organization.