FDA issues limited acne product recalls, AAD releases statement on benzoyl peroxide
Key takeaways:
- On March 10, the AAD clarified research into benzene from benzoyl peroxide is ongoing.
- The next day, the FDA released results from its investigation into benzene contamination, resulting in minimal recalls.
The FDA released results from its investigation of benzene in acne products containing benzoyl peroxide. In light of these findings, the American Academy of Dermatology updated its statement on benzoyl peroxide in personal care products.
On March 10, the AAD released an official statement recommending patients adhere to “best practices” for storing and handling products with benzoyl peroxide.
Precautions recommended by the academy included “storing products according to the manufacturer’s instructions at room temperature or cooler conditions and discarding those that are old or expired or exposed to heat,” the statement read.
“The most important thing here is that if you are a patient and have questions or concerns, ask your board-certified dermatologist, so that you can have shared decision making about the best products for your acne,” Seemal Desai, MD, FAAD, immediate past president of the AAD and the author of the official statement, told Healio.
The AAD’s recommendations were issued in response to “recent reports that have noted that benzoyl peroxide... has the potential to break down into benzene,” a cancer-causing chemical.
Last March, an independent laboratory called Valisure broke the news that acne products containing benzoyl peroxide develop high levels of benzene when handled or stored at higher temperatures, elevating this issue to the forefront of patient and dermatologist concerns.
The AAD clarified that “research on this issue is ongoing” and ensured dermatologists and patients that it will keep them updated on new findings.
On March 11, just a day after the AAD issued its statement, new findings emerged as the FDA announced results from its investigation into 95 benzoyl peroxide-containing acne products thought to be contaminated by benzene.
According to John Barbieri, MD, MBA, assistant professor at Harvard Medical School and director of the advanced acne therapeutics clinic at Brigham and Women’s Hospital, the results are “generally reassuring and a positive next step to ensure the safety of benzoyl peroxide-containing products.”
“The vast majority of products evaluated by the FDA were found to have no or minimal detectable benzene,” Barbieri told Healio. “This highlights that our goal should be for there to be insignificant levels of benzene in these products as most manufacturers are able to achieve this goal.”
The FDA found that more than 90% of tested products had undetectable or extremely low levels of benzene contamination, whereas six products had elevated levels — an amount the agency noted is “fewer” than third-party findings.
In response, the companies listed below voluntarily agreed to recall the following products due to elevated benzene levels:
- 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: Sept. 2025.
- Proactiv Emergency Blemish Relief Cream Benzoyl Peroxide 5%. Lot numbers: V3305A, V3304A. Expiration date: Oct. 2025.
- Proactiv Skin Smoothing Exfoliator. Lot number: V4204A. Expiration date: July 2025.
- SLMD Benzoyl Peroxide Acne Lotion. Lot number: 2430600. Expiration date: March 2025.
- Walgreens Tinted Acne Treatment Cream. Lote number: 49707430. Expiration date: March 2026.
Additionally, the manufacturer of Zapzyt Acne Treatment Gel recalled its product due to benzene contamination after conducting its own testing.
The FDA emphasized that all recalls are being conducted at the retail level, meaning consumers who currently possess these products do not have to take any action.
“It appears the FDA believes that the clinical risk even for the few products being recalled is minimal, hence why [the] recall is at the retail rather than consumer level,” Barbieri said, pointing out the FDA’s notice which read, “Even 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.”
Nevertheless, the FDA wrote that it “continues to underscore and remind” manufacturers, distributors, repackagers and importers that their products should meet high standards of safety and quality.
“As we found in our recent study,” Barbieri said concerning his article in JAMA Dermatology, “there are likely opportunities for manufacturers to re-evaluate their formulation, production and distribution practices to achieve the goal of minimizing the formation of benzene in benzoyl peroxide-containing products to maximize their safety.”
The FDA also expressed concern over “unvalidated testing methods by third-party laboratories,” stating these methods may result in higher reported levels of contaminants, such as benzene, and confusion among consumers.
“I think the FDA study shows that the FDA is wanting to act in the best interest of patient safety, first and foremost,” Desai said. “I think it’s also very important to point out that they were done on over-the-counter products. This has nothing to do with prescription products.”
The AAD now includes the FDA’s announced findings in its official statement on benzoyl peroxide in over-the-counter personal care products. According to the FDA’s release, the agency plans to release the full results in one or more journals in the coming months.
References:
- American Academy of Dermatology statement on benzoyl peroxide in OTC personal care products. https://www.aad.org/news/benzoyl-peroxide-personal-care-products. Published March 10, 2025. Accessed March 12, 2025.
- Limited number of voluntary recalls initiated after FDA testing of acne products for benzene; findings show a small number of products with elevated levels of benzene contamination. https://www.fda.gov/drugs/drug-safety-and-availability/limited-number-voluntary-recalls-initiated-after-fda-testing-acne-products-benzene-findings-show. Published March 11, 2025. Accessed March 12, 2025.