Burkhart topical anesthetic gel — Class II drug recall D-0603-2026
Ongoing recall by Keystone Industries, reported 2026-06-24, distributed nationwide. Defective container:may contain bottles with incomplete seals
| Recall number | D-0603-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Industries, Gibbstown, NJ, United States |
| Recall initiated | 2026-05-21 |
| Classified | 2026-06-18 |
| Reported by FDA | 2026-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 150 units |
| Reason classes | packaging |
| NDC | 43498-0310, 43498-0310-30 |
| Expiration dates | 2029-04-15 |
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
Reason for recall
Defective container:may contain bottles with incomplete seals
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0603-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.