Medications & Supplements/Topical Products

Americaine Benzocaine Topical Anesthetic Spray Recalled for Benzene Presence

Agency Publication Date: January 17, 2024

Summary

Insight Pharmaceuticals is recalling 34,704 cans of Americaine (benzocaine 20%) Benzocaine Topical Anesthetic Spray due to the presence of benzene, a chemical contaminant. Benzene was detected in the aerosol spray during testing, although it is not an intended ingredient in the product. The recall affects 2 oz aerosol cans sold at retailers across the United States. No injuries or adverse events have been reported to date.

Risk

Benzene is classified as a human carcinogen. Long-term exposure through inhalation, skin contact, or ingestion can result in life-threatening blood cancers such as leukemia and other serious blood disorders.

What You Should Do

This recall affects Americaine (benzocaine 20%) Benzocaine Topical Anesthetic Spray sold in 2 oz aerosol cans with lot number 1A16420 and expiration date 01/31/2025 (UPC 363736378820).
Look for the lot number and expiration date printed on the bottom of the aerosol can to determine if your product is included in this recall.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Americaine (benzocaine 20%) Benzocaine Topical Anesthetic Spray (2 oz)

Variants: Benzocaine 20%, Aerosol Spray

UPC Codes:

363736378820

Lot Numbers:

1A16420 (Exp 01/31/2025)

NDC:

63736-378-02

GTIN:

10363736378827

Distributed by Insight Pharmaceuticals Corp. Tarrytown, NY.

Product Images

Image 1 – Labeling – Americaine Benzocaine Tropical Anesthetic Spray 2 oz

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93691

Status: Resolved

Manufacturer: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Sold By: Retailers nationwide

Manufactured In: India, United States

Units Affected: 34,704 cans

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Americaine (benzocaine 20%) Benzocaine Topical Anesthetic Spray sold in 2 oz aerosol cans with lot number 1A16420 and expiration date 01/31/2025 (UPC 363736378820).

Look for the lot number and expiration date printed on the bottom of the aerosol can to determine if your product is included in this recall.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.