Keystone Industries Burkhart topical anesthetic gel Recall

Why it was recalled

Defective container:may contain bottles with incomplete seals

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

Lot numbers, UPCs & expiration codes

BNZ-001917, Exp 04/15/2029

Where it was sold

Nationwide in the USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0603-2026
Classification: Class II
Status: Ongoing
Recall initiated: May 21, 2026
FDA report date: Jun 24, 2026
Quantity: 150 units
Recall type: Voluntary: Firm initiated
Recalling firm: Keystone Industries

Original FDA data

Every field from FDA enforcement report D-0603-2026, exactly as published.

Show all FDA fields

City: Gibbstown
State: NJ
Status: Ongoing
Country: United States
Event ID: 99076
Address: 480 S Democrat Rd
Code information: BNZ-001917, Exp 04/15/2029
Postal code: 08027-1239
Report date: Jun 24, 2026
Product type: Drugs
Recall number: D-0603-2026
Classification: Class II
Recalling firm: Keystone Industries
Product quantity: 150 units
Reason for recall: Defective container:may contain bottles with incomplete seals
Voluntary / mandated: Voluntary: Firm initiated
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
Distribution pattern: Nationwide in the USA
Recall initiation date: May 21, 2026
Initial firm notification: Letter
Center classification date: Jun 18, 2026

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0603-2026, published Jun 24, 2026. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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