FDA warns – Americaine® 20% Benzocaine Topical Anesthetic Spray recalled due to trace of benzene

The FDA is alerting consumers to a nationwide recall of Americaine® 20% Benzocaine Topical Anesthetic Spray by Insight Pharmaceuticals, a company under Prestige Consumer Healthcare Inc., due to the unexpected presence of benzene in the product.

Classified as a carcinogen, humans can be exposed to benzene through inhalation, orally, or via skin contact. It may ultimately lead to cancers that include “leukemia and blood cancer of the bone marrow,” as well as potentially life-threatening blood disorders. Because benzene is present throughout the environment and in multiple sources, humans across the globe are daily exposed while both indoors and outdoors.

Consumers should be aware that benzene is not listed as an ingredient in Americaine® 20% Benzocaine Topical Anesthetic Spray. However, a sample taken from a single lot of the product during a recent review by the manufacturer and a third-party lab indicates that the propellant used to spray the product out of the can emitted a low level of benzene.

While Insight Pharmaceuticals has not received any reports of major adverse events in connection to the recall at the time of writing, the company initiated the consumer-level recall on December 22, 2023 “out of an abundance of caution.”

Company officials note that no other lots of Americaine® 20% Benzocaine Topical Anesthetic Spray outside of the listed batch code are impacted by the recall and may continue to be used safely and as designed.

Distributed across the U.S. through a limited quantity of retailer and via online, the product comes in white 2-ounce (57-gram) aerosol cans bearing teal caps and with lot codes printed on the bottom of each can. Affected cans are found under NDC (National Drug Code) 63736-378-02 and Lot Code 1A16420, with an Expiration date of 01/25.

Following the company’s recall announcement, Insight alerted its retail partners of the problem by overnight mail. The communication called for the removal of all recalled product from store shelves and asked readers to closely follow instructions outlined in the Drug Recall Notification.

Consumers who may have purchased an Americaine® 20% Benzocaine Topical Anesthetic Spray bearing the above lot code are urged to cease use of the product. Those experiencing any health problems that may be related to use of the product should seek medical attention. Insight Pharmaceuticals can be reached via email at medicalaffairs@prestigebrands.com, and its website at https://www.prestigebrands.com/contact. Company representatives can also be contacted by phone at (800) 344-7239 Monday through Friday, from 8:30 a.m. to 5:30 p.m. Eastern Time. Customers may receive a complete refund by submitting a photo of the affected lot code printed at the bottom of the product.

As the FDA continues to monitor this recall, consumers are encouraged to report any major adverse events to the agency’s MedWatch program.


Have you been diagnosed with a cancer, blood disorder, or other adverse health outcome that can be traced to prolonged exposure to benzene in a consumer product? Our experienced attorneys at TruLaw make it our mission to hold negligent parties accountable for pain and suffering. We are personally invested in helping you build a case toward justice and maximum compensation. To learn more about how we can support you, contact us online or take our free Instant Case Evaluation ℠.