Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceu... — FDA record D-0236-2024

Reported completed

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 21, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Reason
Chemical Contamination: presence of benzene
Classification
Class I
Recalling firm
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Quantity
34,704 cans
Agency-reported status
Completed
Source record identifier
D-0236-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot # 1A16420, exp. date 01/31/2025

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jan 24, 2024
Recall initiation date
Dec 21, 2023
Center classification date
Jan 17, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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