Americaine Benzocaine Spray (Insight) – Benzene Contamination (2023)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736-378-02, Can UPC 3 63736 37882 0; Case UPC 1 03 63736 37882 7
Brand
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Lot Codes / Batch Numbers
Lot # 1A16420, exp. date 01/31/2025
Products Sold
Lot # 1A16420, exp. date 01/31/2025
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company is recalling Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by due to Chemical Contamination: presence of benzene. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Chemical Contamination: presence of benzene
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026