Quala Topical Anesthetic Gel
FDA Recall NDC 43128-034
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Quala Topical Anesthetic Gel (NDC 43128-034). A significant event, classified as Class II, was initiated on May 21, 2026 by National Distribution & Contracting, Inc. The reported reason for this action was: "Defective container:may contain bottles with incomplete seals"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Defective container:may contain bottles with incomplete seals
May 21, 2026
Jun 24, 2026
150 units
Recall Profile & Regulatory Data
Event ID
99076
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Keystone Industries
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
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.
Batch or Lot Expiration Information
Lot# BNZ-001921, EXP 04/15/2029
Affected Packages Involved in this Recall
43128-034-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
