Recall Ledger

Burkhart topical anesthetic gel recall (Keystone Industries)

DrugClass IIOngoing

Summary: Keystone Industries is recalling Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30. Reason: Defective container:may contain bottles with incomplete seals.

What is being recalled

Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30

Why

Defective container:may contain bottles with incomplete seals

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Nationwide in the USA

How to tell if yours is affected

BNZ-001917, Exp 04/15/2029

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0603-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedMay 21, 2026
ReportedJune 24, 2026
CompanyKeystone Industries
Company locationGibbstown, NJ, United States
Initiated byVoluntary: Firm initiated
Quantity150 units

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