Keystone Industries recalls

Keystone Industries has 23 recalls on record with the FDA and USDA, the earliest in 2023 and the latest reported on 24 Jun 2026. 11 are still ongoing. 7 were reported in the last 12 months. The most frequent reason is manufacturing (cgmp) deviations.

Total recalls23since 2023
Last 12 months7reported
Class I00% of total
Ongoing11latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 23 100%Class III 0 0%

By year

Ongoing keystone industries recalls

11 active
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIPearson Quality Topical Anesthetic Gel (20% Benzocaine) recalledPearson Topical AnestheticKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIsafco SensiCaine-Ultra (20% Benzocaine) recalled by Keystone IndustriesSafco Sensicaine Ultra Topical Anesthetic GelKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIDental City Topical Anesthetic Gel, Benzocaine recalledDental City Topical AnestheticKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIBurkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor recalledBurkhart Topical AnestheticKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIQuala Dental Products, Topical Anesthetic Gel recalledQuala Topical Anesthetic GelKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIPureLife, Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recalledPurelife Topical AnestheticKeystone IndustriesPackaging DefectsNationwide

All keystone industries recalls, newest first

23 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIPearson Quality Topical Anesthetic Gel (20% Benzocaine) recalledPearson Topical AnestheticKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIsafco SensiCaine-Ultra (20% Benzocaine) recalled by Keystone IndustriesSafco Sensicaine Ultra Topical Anesthetic GelKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIDental City Topical Anesthetic Gel, Benzocaine recalledDental City Topical AnestheticKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIBurkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor recalledBurkhart Topical AnestheticKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIQuala Dental Products, Topical Anesthetic Gel recalledQuala Topical Anesthetic GelKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIPureLife, Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recalledPurelife Topical AnestheticKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIDHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recalledHealth-tec Topical AnestheticKeystone IndustriesPackaging DefectsNationwide
DrugCLASS IIPatterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine recalledPatterson Dental Topical AnestheticKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIBurkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free recalledKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIIpana, 20% Benzocaine Topical Gel, Maxill Inc., St Thomas ON Canada recalledKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIM&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine recalledKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPearson Quality, Topical Anesthetic Gel, 20% Benzocaine recalledKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPrimo, Topical Anesthetic gel, Benzocaine 20%, Net Content recalledKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIHealth-Tec, Topical Anesthetic Gel, Benzocaine recalledHealth-tec Topical AnestheticKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIDental City, Topical Anesthetic Gel, Benzocaine recalledKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIsafco, SensiCaine Ultra, Topical Anesthetic Gel recalledSafco Sensicaine Ultra Topical Anesthetic GelKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIQuala Dental Products, Topical Anesthetic Gel recalledKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIHenry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine recalledKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIGelato, Benzocaine 20% Topical Gel Anesthetic Gel recalledGelato Topical AnestheticKeystone IndustriesManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPerio Maintenance Rinse 0.63% Stannous Fluoride recalledKeystone IndustriesPotency & AssayNationwide
DeviceCLASS IIKeySplint Hard Clear - Indicated recalled by Keystone IndustriesKeystone IndustriesPackaging DefectsNationwide
DeviceCLASS IIHenry Schein Hard Line Chairside Reline kit-Resilient recalledKeystone IndustriesOtherNationwide
DeviceCLASS IIKeystone Bosworth Copaliner Cavity Varnish .- Intended recalledKeystone IndustriesPackaging DefectsNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.