The Recall Desk
ModerateFDA (Drugs)·D-0603-2026·Announced 2026-06-24

Burkhart benzocaine topical anesthetic gel bottles may have incomplete seals

Burkhart topical anesthetic gel, benzocaine 20% strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 150 units are affected.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for a container seal defect with no clinical consequence described in the source, which fits the packaging-related Moderate band.

Plain-English summary

Burkhart topical anesthetic gel, benzocaine 20%, strawberry flavor, 1 oz (30 mL), manufactured for Burkhart Dental Supply of Tacoma, Washington, NDC 43498-310-30, is being recalled. The action covers 150 units.

The stated reason is a defective container: the product may contain bottles with incomplete seals. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.

The affected lot is BNZ-001917, expiring 04/15/2029. Distribution was nationwide in the USA.

Holders of the affected lot should stop using it and follow the instructions issued by the firm.

The recalled product

Product
BURKHART TOPICAL ANESTHETIC (BENZOCAINE)
Brand
BURKHART TOPICAL ANESTHETIC
Affected units
150

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • BNZ-001917
  • Exp 04/15/2029

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Keystone Industries under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →