US FDA Alert regarding Benzene Contamination
- Date
- March 11, 2025
- Category
US Regulations
- Description
In February 2025 the FDA issued an alert to drug manufacturers regarding benzene contamination in certain drugs. Certain hand-sanitizers and aerosol drug products have been recalled due to benzene contamination. This contamination may be related to inactive ingredients such as carbomers (thickening agents), isobutane (a spray propellant), or other drug components made from hydrocarbons.
Manufacturers should not use benzene in the manufacture of drugs and should conduct a risk assessment to determine they have the appropriate specifications, test methods, and controls to ensure drugs are free from contamination. Ingredients that are hydrocarbons or are manufactured with benzene or other hydrocarbons may indicate a higher likelihood of benzene contamination.
FDA is also aware of ingredients, such as the antifungal preservative sodium benzoate, that in combination with chemicals, such as antioxidants in a drug formulation, may yield benzene under certain conditions. The formation of benzene from benzoate can lead to an increase in benzene content over a drug’s shelf-life’ and should be considered when determining the appropriate timing for benzene testing, e.g., testing at release and on stability and establishment of an appropriate expiration date.
Drug products that contain benzene above 2 ppm should not be released. Drug manufacturers with a risk for benzene contamination should test their drugs accordingly. The chart summarises when and how manufacturers should contact FDA if testing reveals the presence of benzene and the information FDA may request from drug manufacturers when following up: