Benzoyl peroxide FDA Alerts

Limited Number of Voluntary Recalls Initiated after FDA Testing of Acne Products for Benzene

Mar 11, 2025 | Audience: Consumer, Pharmacy

March 11, 2025 -- FDA is alerting the public and industry to the results of new agency testing of 95 acne products containing benzoyl peroxide for possible benzene contamination. 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.

FDA initiated independent testing following receipt of third-party testing results submitted to the agency that raised concerns about elevated levels of benzene in certain acne products containing benzoyl peroxide. FDA testing results indicate fewer products with benzene contamination than the third-party findings.

The companies listed below voluntarily agreed to take action to recall certain products (listed below) due to elevated levels of benzene. It is important to note the recalls are being conducted at the retail level, not the consumer level. This means retailers are instructed to remove products from store shelves and online marketplaces but does not specifically instruct consumers to take actions regarding products currently in their possession. 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.

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.

Visit FDA’s drug recalls page or search FDA’s recalls database for additional information and updates on product recalls.

Benzene is a chemical formed in nature and from human activities. It is also a natural part of crude oil, gasoline and cigarette smoke. Exposure to benzene can increase the risk of cancer. Further information regarding benzene in drugs can be found here.

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. FDA tested a total of 95 acne treatment products containing benzoyl peroxide and found six products with elevated levels of benzene. FDA notes that some of these six products are approaching their expiration dates and recommends consumers check their products and throw away products that are beyond their expiration date.  

FDA intends to publish the full results of its testing, including data and information on testing methods, in one or more peer-reviewed journals in the coming months. 

FDA continues to underscore and remind manufacturers, distributors, repackagers and importers that they are responsible for the safety and quality of their products. FDA requires manufacturers to evaluate and test for possible contaminants in their products to ensure they meet specifications and are free from harmful contamination, including benzene. 

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. 

For FDA’s current policy regarding analytical method validation, please see the guidances for industry Q2(R2) Validation of Analytical Procedures and Analytical Procedures and Methods Validation for Drugs and Biologics. Also see the USP’s whitepaper Unvalidated methods for medicine quality testing lead to misleading results for additional discussion.

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.

The agency encourages health care professionals and patients to report adverse events or quality problems to the FDA’s MedWatch Adverse Event Reporting program by:

• Complete and submit the report online
• Download and complete the form, then submit it via fax at 1-800-FDA-0178

Source: FDA

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Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions

Jun 25, 2014 | Audience: Consumer, Pharmacy, Family Practice

Sold under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands.

[Posted 06/25/2014]

ISSUE: FDA is warning that certain over-the-counter (OTC) topical acne products can cause rare but serious and potentially life-threatening allergic reactions or severe irritation. Consumers should stop using their topical acne product and seek emergency medical attention immediately if they experience hypersensitivity reactions such as throat tightness; difficulty breathing; feeling faint; or swelling of the eyes, face, lips, or tongue. Consumers should also stop using the product if they develop hives or itching. The hypersensitivity reactions may occur within minutes to a day or longer after product use.  

These serious hypersensitivity reactions differ from the local skin irritation that may occur at the product application site, such as redness, burning, dryness, itching, peeling, or slight swelling, that are already included in the Drug Facts labels.

The hypersensitivity reactions may occur within minutes to a day or longer after product use.  The OTC topical acne products of concern are marketed under various brand names such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear, and as store brands.  They are available as gels, lotions, face washes, solutions, cleansing pads, toners, face scrubs, and other products.   

BACKGROUND: Based on the information reported to FDA, it cannot be determined if the serious hypersensitivity reactions were triggered by the acne products’ active ingredients, benzoyl peroxide or salicylic acid, the inactive ingredients, or by a combination of both. FDA is continuing to monitor and evaluate this safety issue, and will work with manufacturers regarding any future label changes that would address the risk of severe hypersensitivity reactions.

RECOMMENDATION: Before using an OTC topical acne drug product for the first time, apply a small amount to one or two small affected areas for 3 days to make sure you don’t develop any hypersensitivity symptoms. If no discomfort occurs, follow the directions on the Drug Facts label.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[06/25/2014 - Drug Safety Communication - FDA]
[06/25/2014 - Consumer Update - FDA]

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Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel; Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication; Equate: Medicated Acne Gel

Nov 17, 2008 | Audience: Consumers, dermatologists, pharmacists, other healthcare professionals[Posted 11/17/2008] CSI USA Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of all lots of 1 ounce tubes of 10% Benzoyl Peroxide Acne Cream. The products were recalled because samples of the products were found to contain bacteria, Burkholderia Cepacia, formerly known as Pseudomonas Cepacia. There may be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems. Consumers should discontinue using the product and should return it to the place of purchase. See the company's press release for photos of product packaging.

[November 13, 2008 - Press Release - CSI USA Inc.]

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