Burkhart benzocaine topical anesthetic gel bottles may have incomplete seals
Burkhart topical anesthetic gel, benzocaine 20% strawberry flavor, is being recalled because the product may contain bottles with incomplete seals. 150 units are affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for a container seal defect with no clinical consequence described in the source, which fits the packaging-related Moderate band.
Plain-English summary
Burkhart topical anesthetic gel, benzocaine 20%, strawberry flavor, 1 oz (30 mL), manufactured for Burkhart Dental Supply of Tacoma, Washington, NDC 43498-310-30, is being recalled. The action covers 150 units.
The stated reason is a defective container: the product may contain bottles with incomplete seals. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
The affected lot is BNZ-001917, expiring 04/15/2029. Distribution was nationwide in the USA.
Holders of the affected lot should stop using it and follow the instructions issued by the firm.
The recalled product
- Product
- BURKHART TOPICAL ANESTHETIC (BENZOCAINE)
- Brand
- BURKHART TOPICAL ANESTHETIC
- Manufacturer
- Keystone Industries
- Category
- Drug — Topical anesthetic gel
- Affected units
- 150
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- BNZ-001917
- Exp 04/15/2029
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Keystone Industries under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 7 products in this recall →Related recalls
Same manufacturer · Keystone Industries
See all →- ModerateSafco SensiCaine-Ultra benzocaine gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
- ModeratePearson Quality benzocaine anesthetic gel bottles may have incomplete seals
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- ModerateDHP benzocaine topical anesthetic gel bottles may have incomplete seals
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- ModeratePureLife benzocaine topical anesthetic gel bottles may have incomplete seals
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- ModerateDental City benzocaine anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
Same hazard · defective container
See all →- High
- ModerateQuala Dental benzocaine anesthetic gel bottles may have incomplete seals
FDA (Drugs) · 2026-06-24
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