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Class II · ModerateActive recall

Quala Topical Anesthetic Gel

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBNZ-001921, EXP 04/15/2029
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Defective container:may contain bottles with incomplete seals

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in USA for
Brand nameQUALA TOPICAL ANESTHETIC GEL
Generic nameBENZOCAINE
Active ingredient(s)BENZOCAINE
Distributed by / forKeystone Industries
NDC43128-034-30
Show the full FDA record
Full product labelQuala 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.
Recalling firmKeystone Industries
DistributionNationwide in the USA
Quantity150 units
Recall initiated2026-05-21
Report date2026-06-24
Recall completed—
Recall numberD-0601-2026
ClassificationClass II
FDA statusOngoing
Origin on fileGibbstown NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.