QUALA TOPICAL ANESTHETIC GEL
Recalling Firm / Manufacturer: Keystone Industries
(Gibbstown, NJ, United States)
FDA Recall Number: D-0601-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
QUALA TOPICAL ANESTHETIC GEL
Generic Name
BENZOCAINE
Active Substance(s)
Benzocaine
Administration Route
Dental
National Drug Code (NDC)
43128-034
Total Quantity Recalled
150 units
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Defective container:may contain bottles with incomplete seals
Full Product Description
Packaging specifications and labeling details
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
June 24, 2026
Firm Initiation Date
May 21, 2026
FDA Classification Date
Jun 18, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
BNZ-001921, EXP 04/15/2029
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0601-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508601UTCC