drugs MODERATE Updated 2024-12-25

Keystone Industries recalls Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Fre

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Recalled Product

Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.

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Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-29119

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall