Keystone Industries recalls Dental City topical anesthetic gel due to CGMP deviations during manufacturing. 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 Dental City topical anesthetic gel (Benzocaine 20%) because it was shipped after being rejected for scratches in the mixing vessel. This could affect product safety during manufacturing.
The gel was rejected by quality control due to scratches in the mixing vessel but was shipped to customers. This suggests potential contamination or quality issues that could affect product safety.
Dental professionals and patients using the Dental City topical anesthetic gel (Benzocaine 20%) with lot number BNZ-001646. Those who have the product are most at risk.
Check for the lot number BNZ-001646 on the product label. The product is sold online at dentalcity.com and manufactured in Green Bay, WI.
Look for the lot number BNZ-001646 on the Dental City topical anesthetic gel label.
The product was rejected by quality control for scratches in the mixing vessel but was inadvertently shipped to customers.
The recall record does not specify a remedy.
The expiration date is November 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-0140-2025 — Keystone Industries Keystone Industries Hello, I own a Keystone Industries that is covered by recall D-0140-2025 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.
