FDAFDA recall D-0603-2026 · Jun 24, 2026
Keystone Industries: Burkhart topical anesthetic gel recall
Recall found
Product
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 for recall
Defective container:may contain bottles with incomplete seals
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- BNZ-001917, Exp 04/15/2029
- Quantity
- 150 units
- Distribution
- Nationwide in the USA
- Recalling firm
- Keystone Industries, Gibbstown, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-21
Source: openFDA enforcement record D-0603-2026 · search recall number D-0603-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.