Keystone Industries recalls Benzo-Jel topical anesthetic gel (20% benzocaine) due to quality control failures. The product was rejected but shipped after routine inspection found 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 is recalling Benzo-Jel topical anesthetic gel (20% benzocaine, 1 fl. oz.) because it was shipped after quality control tests found scratches in the mixing vessel. This could lead to contamination or improper product quality.
The gel was produced in a mixing vessel with scratches that were not detected during routine quality checks. This could lead to contamination or improper product quality, but the hazard is not severe enough to cause injury.
Professionals using this gel for medical purposes are affected. The risk is low as the issue relates to manufacturing quality control, not immediate safety hazards.
Check for the lot number BNZ-001646 on the product label. The gel is distributed by Henry Schein and is intended for professional use only.
Look for the lot number BNZ-001646 on the product label to confirm if it is recalled.
The product was rejected but shipped due to quality control issues; it may have contamination risks but is not immediately dangerous.
Check for the lot number BNZ-001646 on the product label. The gel is distributed by Henry Schein and is intended for professional use only.
The official recall record does not specify a remedy, so contact the manufacturer for guidance.
We’ve drafted a message you can send Keystone Industries to request your refund or repair — edit it as you like.
Subject: Recall D-0148-2025 — Keystone Industries Keystone Industries Hello, I own a Keystone Industries that is covered by recall D-0148-2025 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.
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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.
