FDA Alerts of New Independent Testing for Benzoyl Peroxide Acne Products, Additional Voluntary Recalls

The US FDA recently issued an alert regarding potential benzene contamination in benzoyl peroxide (BPO)-containing products.¹ The agency conducted independent testing of 95 acne treatment products after receiving third-party reports raising concerns about elevated benzene levels.

The FDA's findings indicate that more than 90% of the tested products had either undetectable or extremely low levels of benzene. However, 6 products were found to contain elevated levels, leading to voluntary recalls, including that of L’Oréal's recent recall of all lots of its acne treatment Effaclar Duo in the US.²

Background and Testing

Chronic exposure to benzene has been associated with an increased risk of leukemia and other blood disorders.³ Given these risks, the FDA requires manufacturers to evaluate and test for potential contaminants, including benzene, to ensure the safety and quality of their products.

Following the receipt of third-party test results, the FDA conducted its own testing using validated methods. The agency found that the majority of products did not contain benzene at concerning levels.

In contrast, the third-party testing reported more widespread contamination,^4-5 with results detailing benzene contamination in 111 BPO products sold by major US retailers, including levels of contamination exceeding the FDA's limit of 2 parts per million.⁶

Affected Products

Manufacturers of the following BPO acne treatment products voluntarily agreed to recall specific lots due to elevated benzene levels:

• La Roche-Posay Effaclar Duo Dual Action Acne Treatment (Lot MYX46W, Exp. 04/2025)
• Walgreens Acne Control Cleanser (Lot 23 09328, Exp. 09/2025)
• Proactiv Emergency Blemish Relief Cream (Lots V3305A, V3304A, Exp. 10/2025)
• Proactiv Skin Smoothing Exfoliator (Lot V4204A, Exp. 07/2025)
• SLMD Benzoyl Peroxide Acne Lotion (Lot 2430600, Exp. 03/2025)
• Walgreens Tinted Acne Treatment Cream (Lot 49707430, Exp. 03/2026)
• Zapzyt Acne Treatment Gel – Self-reported contamination by manufacturer

The FDA made note that the recalls are being conducted at the retail level, meaning that retailers are instructed to remove these products from store shelves and online marketplaces. However, consumers are not specifically advised to discard products in their possession unless they are past their expiration dates.

The agency has reassured the public that even with daily use of these products over an extended period, the risk of developing cancer from the detected benzene levels remains low.

Regulatory and Safety Concerns

The FDA continues to emphasize the importance of validated analytical methods for detecting contaminants in pharmaceuticals and personal care products. The agency warns that unvalidated third-party testing may produce inaccurate results that do not reflect actual contamination levels.

According to the FDA, it intends to publish full details of its benzene testing, including data and validated test methodologies, in one or more peer-reviewed journals in the coming months. The agency remains committed to monitoring the presence of benzene in pharmaceutical and over-the-counter products and will take further action if necessary.

Preceding Developments

Over the past year, multiple subsequent studies have investigated benzene contamination in BPO products. Research published in Journal of Investigative Dermatology confirmed widespread benzene contamination in 111 BPO products from major US retailers.⁵

Another study in JAMA Dermatology found that benzene levels increased with high-temperature processing but could be mitigated with antioxidants like BHT, highlighting the role of formulation and storage in contamination.⁷ While the chemical link between BPO and benzene is well established, the long-term health risks remain uncertain.

Most recently, a study published in the JID analyzed BPO and its potential link to malignancies, finding a strong signal of increased cancer-related adverse event (AE) reports among BPO users. Using data from the FDA’s Adverse Event Reporting System, researchers identified 452 AE cases from 2019 to Q1 of 2024, with 23 (5.09%) classified as neoplasms, including skin and breast cancer. The study noted that reports of neoplasms increased significantly in the last 2 years.⁸

Statistical analysis showed high reporting odds ratios for malignant neoplasms, skin cancer, and breast cancer, particularly in Proactiv products. While the study does not establish causality, it highlights concerns over benzene contamination in BPO products, aligning with prior research on the topic.

Researchers, including Dermatology Times Editor in Chief Christopher Bunick, MD, PhD, emphasize the need for further studies to assess the long-term safety of BPO, particularly regarding its formulation, storage, and potential to generate benzene.

“The chemical formation of benzene from benzoyl peroxide is well established. Recent research has demonstrated many benzoyl peroxide products have benzene concentrations exceeding the emergency or conditional FDA limit of 2 ppm benzene," said Bunick in a previous interview with Dermatology Times. "While these products are not in line with FDA regulatory policy, the health implications of benzene exposure from BPO products on consumers and patients is less understood. This new research in JID does not establish causality or potential for risk, but does identify a malignancy signal in the FDA’s own adverse event reporting database that warrants further studies into BPO.”

References

1. 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. News Release. US FDA. Published March 11, 2025. Accessed March 12, 2025. https://www.fda.gov/drugs/drug-safety-and-availability/limited-number-voluntary-recalls-initiated-after-fda-testing-acne-products-benzene-findings-show
2. Edney A. L’Oreal recalls acne treatment on cancer-linked chemical. Bloomberg Law. March 10, 2025. Accessed March 10, 2025. https://news.bloomberglaw.com/health-law-and-business/loreal-recalls-acne-treatment-in-us-on-cancer-linked-benzene
3. Benzene and cancer risk. American Cancer Society. Published November 6, 2019. Updated October 13, 2022. Accessed March 12, 2025. https://www.cancer.org/cancer/risk-prevention/chemicals/benzene.html
4. Valisure citizen petition on benzene in benzoyl peroxide drug products. Valisure. March 5, 2024. Accessed March 12, 2025. https://assets-global.website-files.com/6215052733f8bb8fea016220/65e8560962ed23f744902a7b_Valisure%20Citizen%20Petition%20on%20Benzene%20in%20Benzoyl%20Peroxide%20Drug%20Products.pdf
5. Kucera K, Zenzola N, Hudspeth A, et al. Evaluation of benzene presence and formation in benzoyl peroxide drug products. J Invest Dermatol. 2024 Oct 7. doi:10.1016/j.jid.2024.09.009
6. FDA finalizes guidance to limit use of benzene in drug products. Regulatory Affairs Professionals Society. January 2024. Accessed March 12, 2025. https://www.raps.org/news-and-articles/news-articles/2024/1/fda-finalizes-guidance-to-limit-use-of-benzene-in
7. Barbieri JS, Rubin CB, Pham JP, Wong M. The role of formulation in benzene formation in benzoyl peroxide products. JAMA Dermatol. 2025 Feb 12. doi: 10.1001/jamadermatol.2024.6443
8. Zhou S, Yan S, Ming S. A comprehensive study on adverse reactions of benzoyl peroxide (BPO) in dermatological aesthetics utilizing the FAERS database. J Cosmet Dermatol. 24: e16787. https://doi.org/10.1111/jocd.16787