Burkhart Topical Anesthetic Gel
FDA Recall NDC 43498-310
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Burkhart Topical Anesthetic (NDC 43498-310). A significant event, classified as Class II, was initiated on May 21, 2026 by Burkhart Dental Supply Inc. The reported reason for this action was: "Defective container:may contain bottles with incomplete seals"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Defective container:may contain bottles with incomplete seals
May 21, 2026
Jun 24, 2026
150 units
Recall Profile & Regulatory Data
Event ID
99076
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Keystone Industries
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Batch or Lot Expiration Information
Lot# BNZ-001917, Exp 04/15/2029
Affected Packages Involved in this Recall
43498-310-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
