Keystone Industries: Multiple Topical Anesthetic Gels
Keystone recalls 20% benzocaine gels (Pearson, Quala, DHP, etc.) over defective seals.
Stop using the recalled topical anesthetic gel immediately. Check the product label for the affected brands and NDC 43305-0009-3. Contact Keystone Industries for instructions on returning the product and obtaining a refund or replacement.
Why it was recalled
Keystone Industries is recalling multiple brands of topical anesthetic gel containing 20% benzocaine due to defective containers that may have incomplete seals, which could compromise the product's sterility and effectiveness. The affected products include Pearson Quality, Quala, DHP, Burkhart, Dental City, PureLife, and safco SensiCaine-Ultra gels in various flavors and sizes.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
| Product | NDC / UPC | Recall # |
|---|---|---|
| DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g) | NDC 69634-020-30 | D-0602-2026 |
| PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor | NDC 68987-001-30 | D-0605-2026 |
| Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala… | NDC 43128-034-30 | D-0601-2026 |
| safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL) | NDC 67239-0223-1 | D-0606-2026 |
| Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL) | NDC 43498-310-30 | D-0603-2026 |
| Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g) | NDC 69483-001-30 | D-0604-2026 |
| Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g) | NDC 43305-0009-3 | D-0600-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Editorial summary by Recall Canary · summary updated 2026-09-03 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification