During a recent investigation, the U.S. Food and Drug Administration (FDA) conducted testing on 95 acne products containing benzoyl peroxide to assess potential benzene contamination. The results, released on March 11, 2025, revealed that over 90% of the tested products had either undetectable or extremely low levels of benzene. This contradicts earlier findings by independent third-party laboratories that suggested significantly higher levels of benzene contamination in these products.
FDA's Independent Testing and Findings
The FDA initiated this independent testing after receiving concerning third-party results indicating elevated benzene levels in certain benzoyl peroxide acne treatments. In their statement, the FDA notes, “FDA’s testing used validated test methods and assessed all benzoyl peroxide products identified by third-party laboratories as having elevated benzene levels that FDA was able to purchase at the time of testing, as well as additional marketed products.”
Out of the 95 products tested, the FDA found that only six had elevated levels of benzene.
Products Recalled at Retail Level
Based on the FDA’s findings, several companies have voluntarily recalled specific products at the retail level due to elevated benzene levels. The FDA has emphasized that these recalls apply to retailers, meaning stores will remove these products from their shelves. However, consumers have not been specifically directed to take any action on the products they already own.
List of Voluntary Recalls
- La Roche-Posay Effaclar Duo Dual Action Acne Treatment (Lot MYX46W, expiring April 2025)
- Walgreens Acne Control Cleanser (Lot 23 09328, expiring September 2025)
- Proactiv Emergency Blemish Relief Cream Benzoyl Peroxide 5% (Lots V3305A and V3304A, expiring October 2025)
- Proactiv Skin Smoothing Exfoliator (Lot V4204A, expiring July 2025)
- SLMD Benzoyl Peroxide Acne Lotion (Lot 2430600, expiring March 2025)
- Walgreens Tinted Acne Treatment Cream (Lot 49707430, expiring March 2026)
- Zapzyt Acne Treatment Gel – voluntarily recalled by its manufacturer based on elevated benzene levels found during their own testing.
What is the Risk to Consumers?
The FDA has said that even with daily use of these products for decades, the risk of developing cancer from benzene exposure found in these products is very low. They note that benzene is a chemical that occurs both naturally and from human activities, including as a component of crude oil, gasoline, and cigarette smoke.
They further note that some of these products are nearing their expiration dates and encourages consumers to check their products and discard any that have passed their expiration dates.
Future Information
The agency has raised concerns about the accuracy of testing methods used by some third-party laboratories. “Unvalidated testing methods by third-party laboratories can produce inaccurate results leading to consumer confusion. It is critical that third-party laboratories reporting their results to consumers use validated methods so their results are reliable,” the FDA stated.
The FDA plans to publish complete testing results, including data and testing methods, in peer-reviewed journals in the coming months. The agency has also reminded manufacturers, distributors, repackagers, and importers that they bear the responsibility of ensuring the safety and quality of their products, including rigorous testing for possible contaminants.
The FDA will continue monitoring benzoyl peroxide acne products for potential contamination and proactively take actions when quality issues arise.
Source:
- 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
