Topical Anesthetic Gel Recalled for Manufacturing Equipment Defect
Keystone Industries is recalling Benzocaine 20% topical anesthetic gel due to scratches in the manufacturing mixing vessel. Despite Quality Assurance rejection, the product was inadvertently shipped to customers.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
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 CGMP deviations from equipment scratches in manufacturing vessel. No illnesses or injuries reported; hazard is theoretical contamination. Per rubric, Class II without hospitalization reports and theoretical hazard scores as High (3).
Plain-English summary
Keystone Industries is recalling a specific lot of M&S Dental Supply Co LLC. Topical Anesthetic Gel (Benzocaine 20%) due to manufacturing process deviations. During a routine inspection of the manufacturing facility, scratches were discovered on the sides and bottom of a mixing vessel used to produce the product. Although the Quality Unit rejected the product due to these equipment defects, the batch was inadvertently released and shipped to customers.
The affected product (Lot BNZ-001646, Expiration Date 11/26/2026, Keystone Item No. 03-09619) with a net weight of 1 oz (30ml) was distributed nationwide in the United States and Canada, as well as to the Dominican Republic, El Salvador, Honduras, and Qatar.
Scratches in the manufacturing mixing vessel create the potential for product contamination. At this time, no adverse health events have been reported.
The recalled product
- Product
- M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.
- Manufacturer
- Keystone Industries
- Category
- Drug — Topical Anesthetic
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: 03-09619
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Keystone Industries under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 12 products in this recall →Related recalls
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