← Every firm
Keystone Industries FDA Recalls
23 recalls on file across drugs, devices, 0 of them Class I and 11 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental SuppClass IIMay 21, 2026Defective container:may contain bottles with incomplete seal |
| Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 YeClass IIMay 21, 2026Defective container:may contain bottles with incomplete seal |
| PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, ManClass IIMay 21, 2026Defective container:may contain bottles with incomplete seal |
| Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala DentaClass IIMay 21, 2026Defective container:may contain bottles with incomplete seal |
| DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Class IIMay 21, 2026Defective container:may contain bottles with incomplete seal |
| Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: PearsClass IIMay 21, 2026Defective container:may contain bottles with incomplete seal |
| safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: SaClass IIMay 21, 2026Defective container:may contain bottles with incomplete seal |
| Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.Class IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, GlutClass IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): PatterClass IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental ProClass IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala DenClass IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.Class IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental SuClass IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. DemoClass IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental SupplyClass IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental CClass IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), ManufactuClass IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, MelviClass IINov 14, 2024CGMP deviations: the bulk product was rejected by the Qualit |
| Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flaClass IIOct 17, 2024Subpotent Drug |
| KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguaClass IINov 20, 2023Keyprint Keysplint Hard Clear 1 kg resin bottles were inadve |
| Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalClass IIJul 21, 2023A bottle of Copaliner Solvent was inadvertently packaged int |
| Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry SClass IIApr 10, 2023The Hard Line Chairside Reline Kit (570-0718) (0921940HS) wa |