Multi-event May 2026 FDA Recall Quala Topical Anesthetic Gel by Keystone Industries

This Multi-event Class II drug recall was voluntarily initiated by Keystone Industries on May 21, 2026 for the product Quala Topical Anesthetic Gel. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently ongoing.

Reported Recall Events

D-0602-2026 ONGOING D-0605-2026 ONGOING D-0601-2026 ONGOING D-0603-2026 ONGOING D-0600-2026 ONGOING D-0606-2026 ONGOING D-0604-2026 ONGOING

Recall Number: D-0602-2026

Reason for Recall
Defective container:may contain bottles with incomplete seals
Initiated
05-21-2026
Reported
06-24-2026
Quantity
150 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99076
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Keystone Industries
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30

Batch or Lot Expiration Information

Lot# BNZ-001921, EXP 04/15/2029

Affected Packages Involved in this Recall

69634-020-30 Health-tec Topical Anesthetic

Recall Number: D-0605-2026

Reason for Recall
Defective container:may contain bottles with incomplete seals
Initiated
05-21-2026
Reported
06-24-2026
Quantity
450 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99076
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Keystone Industries
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30

Batch or Lot Expiration Information

Lot# BNZ-001921, EXP 04/15/2029

Affected Packages Involved in this Recall

68987-001-30 Purelife Topical Anesthetic

Recall Number: D-0601-2026

Reason for Recall
Defective container:may contain bottles with incomplete seals
Initiated
05-21-2026
Reported
06-24-2026
Quantity
150 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99076
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Keystone Industries
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
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

43128-034-30 Quala Topical Anesthetic Gel

Recall Number: D-0603-2026

Reason for Recall
Defective container:may contain bottles with incomplete seals
Initiated
05-21-2026
Reported
06-24-2026
Quantity
150 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99076
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Keystone Industries
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# BNZ-001917, Exp 04/15/2029

Affected Packages Involved in this Recall

43498-310-30 Burkhart Topical Anesthetic

Recall Number: D-0600-2026

Reason for Recall
Defective container:may contain bottles with incomplete seals
Initiated
05-21-2026
Reported
06-24-2026
Quantity
900 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99076
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Keystone Industries
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3.

Batch or Lot Expiration Information

Lot# BNZ-001917, Exp 04/01/2029

Affected Packages Involved in this Recall

43305-0009-3 Pearson Topical Anesthetic

Recall Number: D-0606-2026

Reason for Recall
Defective container:may contain bottles with incomplete seals
Initiated
05-21-2026
Reported
06-24-2026
Quantity
150 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99076
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Keystone Industries
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.

Batch or Lot Expiration Information

Lot# BNZ-001921, Exp 04/15/2029

Affected Packages Involved in this Recall

67239-0223-1 Safco Sensicaine Ultra Topical Anesthetic Gel

Recall Number: D-0604-2026

Reason for Recall
Defective container:may contain bottles with incomplete seals
Initiated
05-21-2026
Reported
06-24-2026
Quantity
450 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99076
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Keystone Industries
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30

Batch or Lot Expiration Information

Lot# BNZ-001921, Exp 04/15/2029

Affected Packages Involved in this Recall

69483-001-30 Dental City Topical Anesthetic