Keystone Industries recalls Gelato 20% Benzocaine Topical Gel due to CGMP deviations where mixing vessel scratches were found during routine inspection but product was inadvertently shipped.
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 Gelato 20% Benzocaine Topical Gel because quality control failed to catch scratches in the mixing vessel before shipping. This could lead to unsafe product if the gel is used without proper quality checks.
The gel was produced in a mixing vessel with scratches that were not detected during routine quality checks. This could mean the product does not meet safety standards, though the specific risk to users is not clearly described in the recall.
Anyone who purchased the Gelato 20% Benzocaine Topical Gel from Keystone Industries. Users with sensitive skin or those using the gel for medical purposes may be at slightly higher risk.
Check for the product name 'Gelato, Benzocaine 20% Topical Gel Anesthetic Gel', net weight 1 oz. (30ml), manufactured by Keystone Industries at 480 S. Democrat Rd., Gibbstown, NJ 08027. Lot number BNZ-001646 with expiration date 11/26/2026.
Verify the product name, net weight, manufacturer location, lot number, and expiration date to confirm if it's recalled.
The recall states there were scratches in the mixing vessel that were not detected during routine quality checks, but the specific risk to users is not clearly described.
The recall does not specify a remedy, so check the product details to confirm if it's recalled and contact Keystone Industries for further instructions.
Look for the product name 'Gelato, Benzocaine 20% Topical Gel Anesthetic Gel', net weight 1 oz. (30ml), manufactured by Keystone Industries at 480 S. Democrat Rd., Gibbstown, NJ 08027, with lot number BNZ-001646 and expiration date 11/26/2026.
We’ve drafted a message you can send Keystone Industries to request your refund or repair — edit it as you like.
Subject: Recall D-0137-2025 — Keystone Industries Keystone Industries Hello, I own a Keystone Industries that is covered by recall D-0137-2025 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.
