Burkhart topical anesthetic gel recall
FDA recall D-0603-2026 · initiated May 21, 2026
Keystone Industries recalled Burkhart topical anesthetic gel in May 2026 — an FDA Class II recall (D-0603-2026) because Defective container:may contain bottles with incomplete seals.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective container:may contain bottles with incomplete seals
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 150 units
Details
- 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
- Recalling company
- Keystone Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- May 21, 2026
- FDA report date
- Jun 24, 2026
Frequently asked
- Was Burkhart topical anesthetic gel recalled?
- Keystone Industries recalled Burkhart topical anesthetic gel in May 2026 — an FDA Class II recall (D-0603-2026) because Defective container:may contain bottles with incomplete seals. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Burkhart topical anesthetic gel recalled?
- Per the FDA enforcement record, the reason for recall D-0603-2026 was: Defective container:may contain bottles with incomplete seals
- Is a recalled Burkhart topical anesthetic gel dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Burkhart topical anesthetic gel are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — BNZ-001917, Exp 04/15/2029. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0603-2026.