FDA-Drug2026-06-24Class IIPACKAGING DEFECT
Burkhart topical anesthetic gel recalled for defective bottles with incomplete seals
What this means
Burkhart topical anesthetic gel (benzocaine 20%, strawberry flavor) may contain bottles with incomplete seals, which could allow the product to leak or become contaminated. About 150 units with expiration date 04/15/2029 are affected nationwide.
- Check Burkhart topical anesthetic gel bottles for signs of leakage or seal damage before use
- Do not use gel from bottles with incomplete or damaged seals
- Contact your dental supplier or Burkhart Dental Supply if you have affected product
The agency's original wording
Hazard
Defective container:may contain bottles with incomplete seals
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
150 units
Manufactured in
480 S Democrat Rd, Gibbstown, NJ, United States
Products
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0603-2026Want us to check the next one for you?
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