FDA recall, , Moderate risk
Keystone Topical Anesthetic Gels
Topical anesthetic gels may have defective containers with incomplete seals.
Summary by Recall Canary from the FDA notice
What happened
Keystone Industries of Gibbstown, New Jersey, recalled several topical anesthetic gels because the containers may have incomplete seals.
The products include DHP Topical Anesthetic Gel, Purelife Topical Anesthetic Gel, Quala Dental Products, safco SensiCaine-Ultra, Burkhart topical anesthetic gel, Dental City Topical Anesthetic Gel, and Pearson Quality Topical Anesthetic Gel, distributed nationwide in the USA. The recall began May 21, 2026, and was added to the FDA's Enforcement Report on June 18, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
7 products
Affected if its NDC is listed.
An NDC (National Drug Code) is usually printed on the drug's label.
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g)
- NDC
- 69634-020-30
PureLife, Topical Anesthetic Gel, Benzocaine 20%, 1 oz (30mL), Strawberry Flavor
- NDC
- 68987-001-30
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products
- NDC
- 43128-034-30
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL)
- NDC
- 67239-0223-1
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL)
- NDC
- 43498-310-30
Dental City Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 OZ (30 g)
- NDC
- 69483-001-30
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g)
- NDC
- 43305-0009-3
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- Keystone IndustriesGibbstown, New Jersey
- Hazard
- Packaging defect
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99076
- Recall numbers
- D-0600-2026 to D-0606-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
