Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts
Class I · High risk Completed Initiated Dec 21, 2023 (3 years ago)

Americaine (Benzocaine)

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Chemical Contamination: presence of benzene

Cause type: Chemical / undeclared

A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.

What was recalled

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

Affected NDC 63736-0378-02

Compare with the code on your package — it is the most precise check available.

Drug: Benzocaine

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Americaine
Benzocaine
NDC 63736-0378
11.4 g/57g Aerosol, Spray
Topical
Insight Pharmaceuticals LLC OTC
Recalling firm
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
NDC code
63736-378-02
Origin
NY, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0236-2024 · FDA notice

Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now completed, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other Benzocaine recalls

See all
Class II · Moderate risk

safco SensiCaine-Ultra

Defective container:may contain bottles with incomplete seals

Ongoing Packaging defect Keystone Industries NDC 67239-0223-1 D-0606-2026
Class II · Moderate risk

PureLife

Defective container:may contain bottles with incomplete seals

Ongoing Packaging defect Keystone Industries NDC 68987-001-30 D-0605-2026

Other recalls by Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

All 2023 recalls