Patterson Dental Topical Anesthetic Recalled for Manufacturing Quality Defect
Keystone Industries is recalling one lot of Patterson Dental Topical Anesthetic due to manufacturing quality deviations. The product was shipped despite being marked for rejection due to scratches in the mixing vessel.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall involves a CGMP deviation (damaged mixing vessel) with no reported illnesses, injuries, or confirmed contamination. Per the severity rubric, precautionary recalls with only theoretical hazard and no reported harm are classified as Moderate.
Plain-English summary
Patterson Dental Topical Anesthetic (benzocaine), manufactured by Keystone Industries, is being recalled. The affected lot is BNZ-001646 (NDC 50227-1002-3) with an expiration date of November 26, 2026.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during routine quality inspection. Scratches were discovered on the sides and bottom of the mixing vessel used to produce this batch. Although the Quality Unit marked the product for rejection due to these manufacturing defects, it was inadvertently shipped to customers.
The affected product was distributed nationwide in the United States and Canada, as well as to the Dominican Republic, El Salvador, Honduras, and Qatar.
The recalled product
- Product
- PATTERSON DENTAL TOPICAL ANESTHETIC (BENZOCAINE)
- Brand
- PATTERSON DENTAL TOPICAL ANESTHETIC
- 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. 03-27119
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.
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