Keystone Industries recalls Burkhart Topical Anesthetic Gel (Benzocaine 20%) for CGMP deviations during production. The gel was rejected but shipped due to scratches in the mixing vessel.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Keystone Industries has recalled Burkhart Topical Anesthetic Gel (Benzocaine 20%) because it was shipped after being rejected for manufacturing defects. This could pose a risk of contamination or improper product quality.
The gel was rejected during routine quality checks because the mixing vessel had scratches. The product was inadvertently shipped despite being supposed to be rejected, which could lead to contamination or improper product quality.
People who own or use Burkhart Topical Anesthetic Gel (Benzocaine 20%) for dental procedures. Those with allergies to benzocaine or gluten are at higher risk.
Check for the lot number BNZ-001646 and expiration date 11/26/2026 on the product label. The product is sold by Keystone Industries in Tacoma, Washington.
Look for the lot number BNZ-001646 and expiration date 11/26/2026 on the product label.
The product was rejected for manufacturing defects but shipped inadvertently. It may not be safe due to potential contamination or improper quality.
The recall record does not mention any refund or remedy steps.
The recall record does not specify any action steps beyond checking product details.
We’ve drafted a message you can send Keystone Industries to request your refund or repair — edit it as you like.
Subject: Recall D-0143-2025 — Keystone Industries Keystone Industries Hello, I own a Keystone Industries that is covered by recall D-0143-2025 from Keystone Industries. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
