Class I Recall for Contaminated Anesthetic Spray

A single lot of over-the-counter Americaine 20% Benzocaine Topical Anesthetic Spray is under a Class I recall after a sample from the lot revealed a low level of benzene from the propellant that sprays the product out of the can. Benzene is not an ingredient in any Americaine products, according to recalling firm Insight Pharmaceuticals, a Prestige Consumer Healthcare Inc. company.

A Class I recall is the strongest recall designation the US Food and Drug Administration (FDA) can issue. It warns use of the product could cause serious adverse health consequences or death.

“Benzene is classified as a human carcinogen,” explained Insight Pharmaceuticals in a December 22, 2023, statement. “Exposure to benzene can occur by inhalation, orally, and through the skin, and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders, which can be life threatening.”

According to the January 24, 2024, FDA Enforcement Report, the recall affects Americaine 20% Benzocaine Topical Anesthetic Spray in 2-ounce (57-gram) aerosol cans (can NDC 63736-378-02; can UPC 3 63736 37882 0; case UPC 1 03 63736 37882 7) from lot 1A16420 (Exp. 1/31/25). The product was made in India and distributed throughout the United States by Insight Pharmaceuticals Corp., Tarrytown, New York. Nearly 35,000 cans are included in the recall.

Insight Pharmaceuticals voluntarily initiated the recall December 21, 2023. On January 17, 2024, the FDA issued its Class I designation.

Americaine 20% Benzocaine Topical Anesthetic Spray is an over-the-counter product used to temporarily relieve pain and itching caused by minor cuts, scrapes, minor burns, or insect bites.