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About a month after online pharmacy Valisure to the FDA that it had found a known human carcinogen in multiple brands of hand sanitizer, the federal agency announced the first related recall.

New Haven, Connecticut-based Valisure's petition detailed that it had detected benzene as well as contaminants that are potential carcinogens in several batches across multiple brands of hand sanitizer. As a result, the company -- which was founded in 2015 on the premise of independently testing the medications it sells -- asked the FDA to request an immediate recall of the affected batches and update guidance to include an exposure limit for benzene.

On Wednesday, the FDA announced that Scentsational Soaps & Candles had of scented hand sanitizers due to the presence of benzene, methanol, and acetaldehyde. Recalled lots of hand sanitizer had been distributed nationwide through Ulta Beauty, TJ Maxx, and Marshalls retail stores, according to the announcement.

"It's great to see some relatively quick action on our petition," David Light, Valisure's founder and CEO told MedPage Today.

Though Light said that Valisure has yet to receive a response from the FDA on its petition, he said the company believes the swift recall is directly related to it.

"It's really important that other companies follow," Light said. "There haven't been major recalls for a contaminant like benzene for decades."

In the -- which made headlines in the early 1990s -- benzene detected was in parts per billion, Light noted. Valisure's recent findings in hand sanitizer have placed benzene at greater concentrations, in parts per million (ppm).

Benzene is a widely used industrial solvent, is present in substances such as gasoline, cigarette smoke, and forest fires, and is also a feedstock for other chemicals, MedPage Today previously reported. However, during the current public health emergency, FDA has set an interim limit of 2 parts per million for the chemical in liquid hand sanitizers.

Valisure noted in its citizen petition that the company analyzed 260 unique batches of hand sanitizer from 168 brands, and that, of those batches, 44 -- or 17% -- contained benzene levels of at least 0.1 ppm. Twenty-one batches -- or 8% -- contained benzene above the 2 ppm interim limit. And the highest level of benzene detected was 16.1 ppm, which is more than eight times the limit.

As COVID-19 restrictions are lifting, and people interact and rely on hand sanitizer more, the issue of addressing contaminants is even more important, Light said. Valisure is hopeful that the FDA will take action regarding the exposure limit for benzene.

"The FDA takes seriously any safety concerns raised about products we regulate, including hand sanitizers," the agency said in a statement provided to MedPage Today. "While the agency evaluates the submitted citizen petition, we will continue to monitor the hand sanitizer marketplace and manufacturing efforts to help ensure the availability of safe hand sanitizers for U.S. consumers."

It added that it "continues to test hand sanitizer products and proactively work with companies, when appropriate, to recall products and encourage retailers to remove products from store shelves and online marketplaces when quality issues arise."

In a statement, Steve Morrison of Scentsational Soaps & Candles said: "As the owners of the company, my wife and I want to reassure consumers and our customers that we are doing absolutely everything possible to carry out this recall efficiently and effectively and ensure it does not happen again."

Previously, Valisure identified quality issues that led to global recalls of the antacid medication ranitidine and the diabetes drug metformin.

As for hand sanitizer, Valisure is continuing to test products, including through a crowdsourcing effort that allows businesses and consumers to submit samples directly to the company.

"I definitely think there's a lot more work to do in cleaning up the hand sanitizer supply in the United States," Light said.

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