← FDA ENFORCEMENT
D-0603-2026Class II

Keystone Industries

Recalling firm
Keystone Industries
Product type
Drug
Status
Ongoing
Report date
2026-06-24
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
150 units
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Code / lot info

BNZ-001917, Exp 04/15/2029

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.