Keystone Industries recalls Patterson Dental Topical Anesthetic Gel due to CGMP deviations. Scratches in mixing vessel led to product release. Consumers should check NDC 50227-1002-3 and lot number BNZ-001646.
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 Patterson Dental Topical Anesthetic Gel because quality control failed during manufacturing. The gel was released after being rejected for scratches in the mixing vessel, creating a potential risk for contamination.
The gel was rejected by quality control due to scratches in the mixing vessel but was accidentally shipped. This could lead to contamination during production, though the specific risk to users is not clearly described in the recall.
Patterson Dental Topical Anesthetic Gel users who purchased the product with NDC 50227-1002-3 and lot number BNZ-001646 are affected. Dental professionals and patients using this specific gel are most at risk.
Check for NDC code 50227-1002-3 and lot number BNZ-001646 on the product label. The product was manufactured for Patterson Dental Supply, Inc. in Saint Paul, MN.
Look for NDC 50227-1002-3 and lot number BNZ-001646 on the gel container.
The recall states the product was rejected for quality issues but was accidentally shipped. The official notice does not specify if the product is safe to use.
Check the product label for NDC 50227-1002-3 and lot number BNZ-001646.
The recall does not provide specific action steps for consumers, only how to identify the product.
We’ve drafted a message you can send Patterson Dental to request your refund or repair — edit it as you like.
Subject: Recall D-0141-2025 — Patterson Dental Patterson Dental Hello, I own a Patterson Dental that is covered by recall D-0141-2025 from Patterson Dental. 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.