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.
The agency’s classification
FDA (Drugs): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Category
- Drug — Topical Anesthetic
- Affected units
- 34,704
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.
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