Burkhart Topical Anesthetic Gel Recall Due to Defective Containers
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Keystone Industries is recalling 150 units of Burkhart topical anesthetic gel nationwide due to potential incomplete seals on bottles.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 1, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.
What Happened
Keystone Industries initiated a voluntary recall of Burkhart topical anesthetic gel because the product may contain bottles with incomplete seals.
Which Products Are Affected
Burkhart topical anesthetic gel, benzocaine 20%, Strawberry Flavor, 1 oz (30 mL). NDC: 43498-310-30. Lot code: BNZ-001917, Exp 04/15/2029. 150 units distributed nationwide in the USA. Manufactured for Burkhart Dental Supply, Tacoma, Washington. Recall number D-0603-2026. Class II recall.
What You Should Do
Consumers should check product packaging for the affected lot code and expiration date.
Why This Matters
The recall affects a dental product distributed across the United States and involves a potential container defect.
Source
FDA recall D-0603-2026
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (766 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 1, 2026.
Frequently Asked Questions
Common questions about this FDA recall.