TOPIC: Acne Products: Limited Number of Voluntary Recalls Initiated: After FDA Testing Findings Show a Small Number of Products with Elevated Levels of Benzene Contamination
AUDIENCE: Consumer, Patient, Health Care Professional, Pharmacy, Dermatology
ISSUE: 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 voluntarily agreed to take action to recall certain products (listed on the web page) 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.
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 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 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.
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.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: 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.
RECOMMENDATIONS:
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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.
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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.
- Visit FDA’s drug recalls page or search FDA’s recalls database for additional information and updates on product recalls.
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