Benzene in sprays, sanitizers and acne products, and the limits FDA set

In July 2021, a sunscreen spray became the first aerosol product to turn up in FDA's enforcement records with benzene given as the reason for recall. Over the next two and a half years, 55 recall records followed for spray products, including more sunscreens, antiperspirants, antifungal foot sprays and a topical anesthetic spray, and 31 of them were Class I, according to GxRadar's search of FDA's openFDA enforcement database⁸.

Benzene is not an ingredient in any of these products. It is an industrial chemical and "a known human carcinogen that causes leukemia and other blood disorders," in the words of FDA's alert to drug manufacturers¹. It got into consumer drugs through the side door: through propellants, thickeners and, in one case, the breakdown of the active ingredient itself.

FDA has since set out how much benzene it will tolerate in a drug and pushed the industry away from one family of ingredients made with it. The recall records show two distinct waves: a burst of mostly Class I spray and sanitizer recalls that ended in early 2024, and a milder run of acne-product recalls that continued into 2026.

Where benzene in drug products comes from

FDA's alert¹, last updated in July 2025, names several routes. Contamination "may be related to inactive ingredients, such as carbomers (thickening agents), isobutane (a spray propellant), or other drug components made from hydrocarbons, or to degradation of certain active ingredients." Benzoyl peroxide, a common acne ingredient, "may degrade into benzene under certain conditions (such as extreme temperatures)." The preservative sodium benzoate can also form benzene when combined with certain antioxidants, so levels may rise over a product's shelf life.

That last point changes how testing has to work. A batch that passes at release could fail later, so FDA tells manufacturers to consider testing on stability as well as at release, and to treat any change of raw material supplier as a reason for extra scrutiny. It is the same problem, in a different chemical, that drove the nitrosamine recalls of 2018 to 2020.

How the 2 ppm limit works

The number most often quoted is 2 parts per million. It comes from the international residual solvents guideline, ICH Q3C, which lists benzene as a Class 1 solvent that "should not be employed in the manufacture of drug substances, excipients, and drug products" unless its use is unavoidable, and then caps it at 2 ppm, according to the Q3C tables FDA publishes⁴.

FDA's alert explains that the 2 ppm figure assumes a 10-gram daily dose and is meant to keep exposure under 20 micrograms of benzene a day, a level the agency ties to a lifetime excess cancer risk of 1 in 100,000. For products used in larger amounts, the concentration limit has to be lower. The agency gives the formula, concentration (ppm) equals 1,000 times the permitted daily exposure in milligrams, divided by the daily dose in grams. The table below applies it to a few doses as an illustration.

FDA said it began with a stepwise approach, first identifying products that should be recalled or held back because they exceeded 2 ppm, then refining limits product by product. Manufacturers should not release any batch "that would expose consumers to more than 20 mcg per day of benzene from the product," the alert¹ says, and holders of brand or generic applications must file a Field Alert Report if a distributed batch fails. Companies that find benzene below the action level are asked to email the agency anyway.

The carbomer problem and the 2023 guidance

Carbomers are acrylic acid polymers used to thicken gels and creams, and some are made using benzene as a solvent. Certain official carbomer monographs in the United States Pharmacopeia allowed benzene "of 100 ppm or greater," FDA said, 50 times the Q3C limit. At FDA's request, USP issued a notice on Nov. 18, 2022, saying it intended to drop the monographs for Carbomer 934, 934P, 940, 941 and 1342, with a targeted date of Aug. 1, 2026, according to the agency¹. That page was last updated in July 2025, and GxRadar did not independently confirm whether the change took effect on schedule.

In December 2023 FDA issued a final guidance, Reformulating Drug Products That Contain Carbomers Manufactured With Benzene², which tells manufacturers what testing and paperwork FDA expects when they switch to a benzene-free carbomer. It took effect immediately, without the usual comment period first. FDA's Federal Register notice³ said that was because "benzene is a known human carcinogen" and the agency sought "to facilitate the transition away from using carbomers manufactured with high levels of benzene." The guidance sets testing expectations that vary with the route of administration and dosage form.

For an approved drug, swapping an inactive ingredient normally means filing data with FDA under its rules for post-approval changes. The same notice said the guidance offers "a less burdensome risk-based approach to applicant submissions" than the agency's existing guidance on such changes. GxRadar's explainer on what a generic must share with its brand covers which ingredients are allowed to differ.

What the recall records show

GxRadar searched openFDA for drug recalls whose reason mentions benzene and grouped them by product type. The search excludes 2013 records for a different chemical whose name contains the word and a 2019 sanitizer recall for related "substituted benzene" compounds.

Two patterns stand out. The spray and sanitizer recalls were mostly Class I, FDA's most serious tier (GxRadar's look at Class I records puts them in context), while every benzoyl peroxide recall was Class II. And the aerosol wave was short; no spray recall for benzene appears in the database after February 2024. FDA's hand sanitizer do-not-use list⁷ separately includes more than 20 entries that cite benzene, alongside the far larger set of methanol sanitizer recalls of 2020 and 2021. Our guide to how drug recalls work explains the classes, and the full record set is on GxRadar's recalls page.

The acne product findings

The most recent wave involved benzoyl peroxide. After receiving third-party test results that raised concerns, FDA tested 95 acne products containing the ingredient and announced on March 11, 2025, that "more than 90% of tested products had undetectable or extremely low levels of benzene," according to its statement⁵. A limited number were recalled at the retail level, meaning stores pulled them but buyers were not specifically told to act. FDA said its testing found fewer contaminated products than the outside lab had reported, and that "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."

FDA's consumer FAQ⁶ says the health effect of benzene depends on "the amount, route, and length of time of exposure." Recalls in this group continued into March 2026 in the openFDA data. Questions about a particular product are best taken to a pharmacist. Our guide to checking whether a medicine was recalled shows where to look, and our page on store-brand OTC medicines explains why one recall can touch several labels at once.