Pearson Quality Topical Anesthetic Gel Recalled Due to Manufacturing Defect
Keystone Industries is recalling Pearson Quality Topical Anesthetic Gel (20% Benzocaine) due to manufacturing equipment defects that could allow product contamination. The affected lot was inadvertently shipped despite quality control rejection.
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: Risk-of-harm product (topical anesthetic for professional use) with manufacturing defect (contamination risk from equipment damage). FDA Class II with no reported illnesses or injuries.
Plain-English summary
Keystone Industries is recalling Pearson Quality Topical Anesthetic Gel, 20% Benzocaine (Lot BNZ-001646, Expires 11/26/2026), manufactured for Pearson Dental Supply Inc. The product is a professional-use topical anesthetic for dental and oral applications.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. During routine quality inspection, scratches were discovered on the sides and bottom of the mixing vessel used in production. This manufacturing defect created a potential contamination risk. Although quality control rejected the batch, it was inadvertently released and shipped to customers.
The affected product was distributed nationwide in the United States and Canada, as well as in the Dominican Republic, El Salvador, Honduras, and Qatar.
Dental professionals who have received this product should stop using it and contact Pearson Dental Supply Inc. or Keystone Industries for instructions on returns or destruction.
The recalled product
- Product
- Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.
- 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. 03-30619
Distribution
Distributed nationwide across the United States.
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