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# FDA Alert on Benzene Contamination in Products
- URL: https://www.fdaweb.com/fda-alert-on-benzene-contamination-in-products/
- Published: 2025-07-25T12:00:00.000Z
- Updated: 2026-09-14T15:17:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159569

FDA has issued an alert based on its ongoing investigation into the root causes of benzene contamination, calling on drug makers to evaluate their manufacturing processes, particularly where ingredients derived from hydrocarbons are used. The agency identified several components of concern, including carbomers (thickening agents), isobutane (a spray propellant), and benzoyl peroxide, an active ingredient in many acne medications. These substances, or their degradation byproducts, may lead to the formation of benzene under certain conditions, it says.

Benzene, a known human carcinogen linked to leukemia and other blood disorders, has been detected in some over-the-counter and prescription medications, prompting multiple product recalls over recent years, according to the [alert](https://www.fda.gov/drugs/pharmaceutical-quality-resources/fda-alerts-drug-manufacturers-risk-benzene-contamination-certain-drugs?ref=fdaweb.com). The agency is particularly concerned about benzene formation over a product’s shelf life. Ingredients like sodium benzoate, a common preservative, may contribute to benzene formation when combined with antioxidants or under high heat. Such risks must be factored into a product’s stability testing and expiration dating, FDA says.

"Manufacturers must ensure that both active and inactive ingredients, as well as finished drug products, meet strict quality specifications to prevent contamination," the agency says, citing federal manufacturing regulations (21 CFR 211.84, 211.160, and 211.165). It also reminded manufacturers of their responsibility to test raw materials and finished products for purity, potency, and identity before releasing them to the market.

FDA is also urging companies to conduct robust risk assessments for all ingredients — especially those made with or from hydrocarbons—and to avoid the use of benzene in drug manufacturing altogether. While limited exceptions exist under international guidelines, such as the ICH Q3C standard, benzene use is only permitted when its presence is deemed unavoidable and justified by a significant therapeutic benefit.

Under ICH guidelines, the alert says benzene levels in drug products should not exceed two parts per million if the daily dose of the product is 10 grams. This limit is based on a daily exposure cap of 20 micrograms of benzene. Products with different daily dosages must meet proportionally adjusted concentration limits to stay within the same exposure threshold. FDA says it plans to issue guidance to help manufacturers calculate product-specific benzene concentration limits.