Medicine recalls
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| The United States: 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 |
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The US Food and Drug Administration (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. The affected products are:
- La Roche-Posay Effaclar Duo Dual Action Acne Treatment (lot number: MYX46W)
- Walgreens Acne Control Cleanser (lot number: 23 09328)
- Proactiv Emergency Blemish Relief Cream Benzoyl Peroxide 5% (lot number: V3305A; V3304A)
- Proactiv Skin Smoothing Exfoliator (lot number: V4204A)
- SLMD Benzoyl Peroxide Acne Lotion (lot number: 2430600)
- Walgreens Tinted Acne Treatment Cream (lot number: 49707430)
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 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 the products 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.
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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/drugs/drug-safety-and-availability/limited-number-voluntary-recalls-initiated-after-fda-testing-acne-products-benzene-findings-show
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Mar 12, 2025
Issued at HKT 16:00
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