After a March 6, 2025 report from an independent testing facility claimed that a significant number of acne products containing benzoyl peroxide were found to have very high levels of benzene (here), the threat has been countered by the FDA’s own testing of 95 products. After the FDA’s testing results were confirmed, it announced that the “FDA has concluded that a limited number of products should be recalled at the retail level; more than 90% of tested products had undetectable or extremely low levels of benzene.” Also see our previous post on this issue here.
According to the FDA’s posting (which you can read here), six lots of product from five different distributors were voluntarily recalled based on the FDA test results. “Additionally, the manufacturer of another benzoyl peroxide acne product, Zapzyt Acne Treatment Gel, agreed to voluntarily recall this product due to the elevated level of benzene found during its own testing.” The FDA said that most of the products tested were at the end of their expiration date and, based on the low levels of benzene detected in their own labs, the recall was only to the retail level and NOT to the patient level. The FDA concluded that “[e]ven with daily use of these products for decades, the risk of a person developing cancer because of exposure to benzene found in these products is very low.”
Regarding the third-party testing, the “FDA has continued to raise concern that use of unvalidated testing methods by third-party laboratories can produce inaccurate results leading to consumer confusion. 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.” The Agency went on to say that the “FDA is committed to ensuring drugs Americans use are safe and effective and will continue its efforts to monitor the issue of benzene in drugs and proactively take actions when quality issues arise. The agency continually gains additional knowledge about drugs which allows it to identify and quickly address previously unknown risks. FDA will communicate new information regarding benzene in drugs as it becomes available.”
