CLASS II ONGOING Drug recall · Reported 24 Jun 2026 · FDA Enforcement Report
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor recalled
Keystone Industries is recalling Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, distributed nationwide in the US. The recall was initiated on 21 May 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0603-2026
- FDA event ID
- 99076
- Recalling firm
- Keystone Industries, Gibbstown, NJ
- Manufacturer
- Burkhart Dental Supply Inc
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 May 2026
- FDA classified
- 18 Jun 2026
- Reported
- 24 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Creams, Ointments & Gels
Timeline
| 21 May 2026 | Recall initiated by company | |
| 18 Jun 2026 | Classified by FDA | +28 days |
| 24 Jun 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container:may contain bottles with incomplete seals
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Defective container:may contain bottles with incomplete seals
Which lots are affected?
BNZ-001917, Exp 04/15/2029
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 99076This product is part of a recall event; the main page for the event is DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recalledHealth-tec Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide | |
| CLASS II | PureLife, Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recalledPurelife Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide | |
| CLASS II | Quala Dental Products, Topical Anesthetic Gel recalledQuala Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide | |
| CLASS II | Dental City Topical Anesthetic Gel, Benzocaine recalledDental City Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide | |
| CLASS II | safco SensiCaine-Ultra (20% Benzocaine) recalled by Keystone IndustriesSafco Sensicaine Ultra Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide | |
| CLASS II | Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recalledPearson Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
More recalls from Keystone Industries
All 23| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recalledPearson Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | safco SensiCaine-Ultra (20% Benzocaine) recalled by Keystone IndustriesSafco Sensicaine Ultra Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Dental City Topical Anesthetic Gel, Benzocaine recalledDental City Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Quala Dental Products, Topical Anesthetic Gel recalledQuala Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | PureLife, Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recalledPurelife Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
Other Benzocaine recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recalledPearson Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | safco SensiCaine-Ultra (20% Benzocaine) recalled by Keystone IndustriesSafco Sensicaine Ultra Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Dental City Topical Anesthetic Gel, Benzocaine recalledDental City Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | Quala Dental Products, Topical Anesthetic Gel recalledQuala Topical Anesthetic Gel | Keystone Industries | Packaging Defects | Nationwide |
| Drug | CLASS II | PureLife, Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recalledPurelife Topical Anesthetic | Keystone Industries | Packaging Defects | Nationwide |