Dental City Topical Anesthetic Gel Recalled Due to Manufacturing Defect
Dental City Topical Anesthetic Gel (Benzocaine 20%) is recalled because the product was released and distributed despite failing quality inspection. Scratches were found in the mixing vessel during routine inspection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard—potential contamination from a manufacturing defect (scratched mixing vessel)—is theoretical. Per the rubric, recalls with no reported illness and theoretical hazard score at most 3.
Plain-English summary
Dental City Topical Anesthetic Gel (Benzocaine 20%, 1 oz / 30 ml, Lot BNZ-001646, expiration 11/26/2026) is being recalled. During routine quality inspection, scratches were discovered on the sides and bottom of the manufacturing mixing vessel. The batch was rejected by the Quality Unit, but was inadvertently released and shipped to customers.
The affected product was distributed nationwide throughout the USA and Canada, as well as the Dominican Republic, El Salvador, Honduras, and Qatar.
Consumers or healthcare facilities with this product should contact Keystone Industries, the manufacturer, for instructions on returning or disposing of the product.
The recalled product
- Product
- Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com.
- Manufacturer
- Keystone Industries
- Category
- Drug — Topical Anesthetic
- Hazard
- manufacturing-defect
- contamination-risk
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 (3)
- Lot: BNZ-001646
- Exp Date: 11/26/2026
- Keystone Item No. 03-25119
Distribution
Distributed nationwide across the United States.
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