Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Drug Safety and Availability

Drug Safety and Availability

                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections Home
          Drugs
          Drug Safety and Availability
          Frequently Asked Questions on Benzene Contamination in DrugsDrug Safety and Availability Frequently Asked Questions on Benzene Contamination in Drugs
  
  	
    Share
    Post
    Linkedin

    Email
    Print**Q: What is benzene?**

**A**: Benzene is a chemical used in the production of a wide range of industrial products, including chemicals, dyes, detergents, and some plastics. Benzene is released into the air in cigarette smoke, emissions from automobiles, and burning coal and oil.

**Q: What should consumers know about drugs being recalled for benzene contamination?**

**A**: Certain hand sanitizers and aerosol (spray) drugs, including antiperspirants and sunscreens, have been recalled due to benzene contamination.

Consumers should stop using products that have been recalled as well as those hand sanitizers FDA recommends consumers should not use, including hand sanitizers tested by FDA and found to contain unacceptable levels of benzene.

**Q: What is the risk from using drugs contaminated with benzene?**

**A**: The health consequences of benzene exposure depend on the amount, route, and length of time of exposure, as well as age and preexisting medical conditions. FDA recommends consumers do not use certain hand sanitizer products, or those that have been recalled.

In small amounts over long periods of time, benzene can decrease the formation of blood cells. Long term exposure to benzene through inhalation, oral intake, and skin absorption may result in cancers such as leukemia and other blood disorders.

FDA continues to monitor the quality of drugs and, when appropriate, encourages retailers to remove products from store shelves and online marketplaces when issues arise.

**Q: Should consumers continue using sunscreen?**

**A**: Yes. Sun safety is important for everyone and all skin colors, and consumers can reduce risks from sun exposure with continued use of sun protection measures, including sunscreen. FDA recommends consumers use broad spectrum sunscreens with SPF values of at least 15, which have been shown to reduce the risk of skin cancer and early skin aging when used with other sun protection measures. These kinds of sunscreens are only one element of a skin-cancer prevention strategy that should also include other sun protective behaviors such as wearing protective clothing that adequately covers the arms, torso, and legs; wearing sunglasses and a hat that provides adequate shade to the whole head; and seeking shade whenever possible during periods of peak sunlight. Medical authorities such as the Center for Disease Control and Prevention, the American Academy of Dermatology, and major physicians’ associations endorse similar recommendations. More about sun protection and sunscreens can be found on the FDA website. Pregnant women and persons concerned about using sunscreens on infants or children are encouraged to consult their health care professional. In addition, FDA recommends consumers do not use recalled sunscreen products.

**Q: What is FDA doing to protect consumers from drugs contaminated with benzene?**

**A**: FDA is committed to ensuring drugs Americans use are safe and effective. FDA continues to monitor the issue of benzene in drugs and is proactively working with companies, when appropriate, to recall products and encourage retailers to remove products from store shelves and online marketplaces when quality issues arise. FDA is evaluating the root cause of benzene contamination and has alerted companies to the risk of benzene contamination in drug products and reminded them of their obligation to ensure their products meet appropriate quality specifications. We continually gain additional knowledge about drugs which allows us to identify and quickly address previously unknown risks to consumers. FDA will communicate new information as it becomes available.

**Q: Is benzene in drugs a new problem? Why have there been so many recent reports of drugs containing benzene?**

**A**: While benzene is not usually used in the manufacture of drugs, the contamination may be related to inactive ingredients in drugs such as carbomers (thickening agents), isobutane (a spray propellant), or other drug components made from hydrocarbons (chemicals made of hydrogen and carbon).

FDA has recommended the United States Pharmacopeia (USP) remove (or “omit”) certain carbomer monographs from their compendium that allow for unacceptable levels of benzene (a USP monograph is a written document that provides the quality expectations for a medicine or ingredient).  USP is working on the official removal of those carbomers from the USP monographs. FDA is publishing this guidance without prior public comment due to an immediate public health need to expedite the discontinuation of the use of, and facilitate the transition away from using, carbomers manufactured with high levels of benzene. Proactive efforts will help avoid causing supply disruptions from the immediate removal of the carbomer monographs.

The agency has also alerted drug manufacturers to the risk of benzene contamination in certain drugs. This alert has resulted in, among other things, several recent recalls of drugs containing unacceptable levels of benzene.

FDA has ongoing assessment, surveillance, compliance and pharmaceutical quality efforts across every product area, and we will continue to work with drug manufacturers to ensure the availability of safe and effective drugs for the American public.

**Q: Why did FDA not immediately alert manufacturers to the potential of benzene in drugs if this was a concern brought to FDA in March 2021?**

**A**: FDA has been working with companies to address benzene issues in drugs prior to March 2021, including through recalls. In 2020, FDA identified the potential for unacceptable levels of benzene in certain carbomers (which may be used as thickening agents in drugs) based on the allowable limits in USP monographs. FDA has been in communication with USP about removing (or omitting) those carbomer monographs from their compendium since late 2020.  On November 18, 2022, in response to FDA’s request, the USP issued a Notice of Intent to Revise, stating that it intends to omit the Carbomer 934, Carbomer 934P, Carbomer 940, Carbomer 941, and Carbomer 1342 monographs, with a targeted date of August 1, 2025. In December 2023, FDA issued a guidance that provides recommendations to applicants and manufacturers on what tests should be performed and what documentation should be submitted or available to FDA to support reformulation of drug products that use carbomers manufactured with benzene.

In March 2021, FDA received a citizen petition raising concerns about the level of benzene in certain hand sanitizers and other products. Subsequently, two other petitions were filed raising concerns about the level of benzene in spray sunscreens, spray antiperspirants, and other drug and cosmetic products. FDA evaluates and assesses the information provided in citizen petitions of this type and, if appropriate, initiates an independent testing and verification process. This process includes securing product samples and performing independent evaluation of collected samples to assess the data presented in the citizen petition. If FDA’s testing raises any safety concerns, then FDA will work with manufacturers to address those concerns. We are going through that process with each of these citizen petitions. During this time, FDA has also been working with companies on multiple recalls related to the identification of unacceptable levels of benzene in drugs.

**Q: What should manufacturers know about benzene in drugs?**

**A**: FDA has alerted drug manufacturers to the risk of benzene contamination from drug components and other potential risk factors. Manufacturers should generally not use benzene in the manufacture of drugs. The International Conference on Harmonization (ICH) *Q3C Impurities: Residual Solvents guidance* describes limited cases where the presence of benzene may be tolerated.

Drug manufacturers are required to ensure the safety and quality of their drugs. As FDA works to better understand the potential sources of benzene in drugs, FDA reminds manufacturers of drugs marketed under approved applications and manufacturers of other drugs, including over-the-counter monograph drug products, of their obligation to ensure their products conform to appropriate quality specifications.

Drug manufacturers with a risk for benzene contamination should test their drugs accordingly and should not release any drug product batch that contains benzene above 2 parts per million (ppm), consistent with the recommendations described in ICH Q3C. Drug manufacturers should contact FDA using the information provided in FDA’s alert if their testing reveals benzene in a product.

Resources

FDA Recalls | Recalls, Market Withdrawals, & Safety Alerts
	FDA updates on hand sanitizers consumers should not use
	Sunscreen: How to Help Protect Your Skin from the Sun
	FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs

                                                                                  Content current as of:
      12/27/2023
              
              
Regulated Product(s)
		 DrugsDrug Safety and Availability

          
                        Drug Alerts and Statements
          Information about Nitrosamine Impurities in Medications
          Medication Guides
          Drug Safety Communications


                        Food and Drug Administration Overdose Prevention Framework
          Drug Shortages
          FDA Drug Safety Podcasts
          Information by Drug Class
          Medication Errors Related to CDER-Regulated Drug Products
          Postmarket Drug Safety Information for Patients and Providers
          Risk Evaluation and Mitigation Strategies | REMS
          Safe Use Initiative
          Drug Recalls
          Drug Supply Chain Integrity
          Multistate outbreak of fungal meningitis and other infections
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop