Keystone Industries recalls Ipana 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 Ipana 20% Benzocaine Topical Gel (28g) because the mixing vessel had scratches that were found during routine inspection but the product was still shipped. This could lead to contamination risks if the product was not properly handled during manufacturing.
The product was rejected by the Quality Unit after routine inspection found scratches on the mixing vessel. However, the product was inadvertently released and shipped to customers, potentially leading to contamination risks if the product was not handled properly during manufacturing.
People who own or use Ipana 20% Benzocaine Topical Gel (28g) with lot number BNZ-001646, manufactured in St. Thomas, Ontario, Canada, and expired by November 26, 2026. Those most at risk are individuals using the product for medical purposes.
Check for the lot number BNZ-001646 on the product label. The product was manufactured in St. Thomas, Ontario, Canada, and expires November 26, 2026.
Look for the lot number BNZ-001646 on the Ipana 20% Benzocaine Topical Gel (28g) product label.
The product was recalled because the mixing vessel had scratches that were found during routine inspection but the product was inadvertently shipped to customers.
The lot number for this product is BNZ-001646.
This product was manufactured in St. Thomas, Ontario, Canada, and expires 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-0147-2025 — Keystone Industries Keystone Industries Hello, I own a Keystone Industries that is covered by recall D-0147-2025 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.
