Class II · Moderate risk
safco SensiCaine-Ultra
Defective container:may contain bottles with incomplete seals
Burkhart topical anesthetic gel (Benzocaine)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Defective container:may contain bottles with incomplete seals
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
What was recalled
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Affected NDC
43498-0310-30
Compare with the code on your package — it is the most precise check available.
Drug: Benzocaine
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Burkhart Topical Anesthetic Benzocaine NDC 43498-0310 |
200 mg/g | Gel Dental |
Burkhart Dental Supply Inc | OTC |
- Recalling firm
- Keystone Industries
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0603-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Benzocaine recalls
See all
Class II · Moderate risk
PureLife
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Dental City TOPICAL ANESTHETIC GEL
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
DHP Topical Anesthetic Gel
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Quala Dental Products
Defective container:may contain bottles with incomplete seals
Other recalls by Keystone Industries
All 2026 recalls
Class II · Moderate risk
safco SensiCaine-Ultra
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
PureLife
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
Dental City TOPICAL ANESTHETIC GEL
Defective container:may contain bottles with incomplete seals
Class II · Moderate risk
DHP Topical Anesthetic Gel
Defective container:may contain bottles with incomplete seals
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