The Recall Desk
SevereFDA (Drugs)·D-0236-2024·Announced 2024-01-24

Topical Drug Recalled: Americaine Benzocaine Spray Contaminated with Benzene

Americaine benzocaine 20% topical anesthetic spray is being recalled nationwide due to benzene chemical contamination. The recall affects 34,704 cans with lot number 1A16420 and expiration date 01/31/2025.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum severity score of 4 per the rubric. The source indicates benzene contamination in this pharmaceutical product.

Plain-English summary

Americaine (benzocaine 20%) topical anesthetic spray distributed by Insight Pharmaceuticals LLC is being recalled nationwide due to chemical contamination with benzene. The product was manufactured in India.

The affected product is the 2 oz (57 g) aerosol spray with lot number 1A16420 and expiration date 01/31/2025. This recall involves 34,704 cans distributed nationwide. Consumers with this product should consult their healthcare provider regarding the contamination.

The recalled product

Product
AMERICAINE (BENZOCAINE)
Brand
AMERICAINE
Manufacturer
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company
Hazard
  • benzene
  • chemical-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 1A16420
  • exp. date 01/31/2025

UPCs (1)

  • 363736378820

Distribution

Distributed nationwide across the United States.