Keystone Industries recalls
Keystone Industries appears in 23 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-24.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 23 |
|---|---|
| Published | 2023-09-20 to 2026-06-24 |
| By agency | FDA Drug (20), FDA Device (3) |
| By classification | Class II (23) |
| By status | terminated (12), ongoing (11) |
| Distribution named in notices | US |
Recalls
- safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co.…
FDA Drug · Class II · 2026-06-24 · Keystone Industries
Reason: Defective container:may contain bottles with incomplete seals - Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in…
FDA Drug · Class II · 2026-06-24 · Keystone Industries
Reason: Defective container:may contain bottles with incomplete seals - Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply In…
FDA Drug · Class II · 2026-06-24 · Keystone Industries
Reason: Defective container:may contain bottles with incomplete seals - Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay,…
FDA Drug · Class II · 2026-06-24 · Keystone Industries
Reason: Defective container:may contain bottles with incomplete seals - DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, In…
FDA Drug · Class II · 2026-06-24 · Keystone Industries
Reason: Defective container:may contain bottles with incomplete seals - PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLif…
FDA Drug · Class II · 2026-06-24 · Keystone Industries
Reason: Defective container:may contain bottles with incomplete seals - Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washing…
FDA Drug · Class II · 2026-06-24 · Keystone Industries
Reason: Defective container:may contain bottles with incomplete seals - Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Av…
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washingto…
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made…
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30…
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For…
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply,…
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI…
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Den…
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distribute…
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown…
FDA Drug · Class II · 2024-12-25 · Keystone Industries
Reason: CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvert… - Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint flavor, Manufactured b…
FDA Drug · Class II · 2024-11-20 · Keystone Industries
Reason: Subpotent Drug - KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, reposi…
FDA Device · Class II · 2024-01-10 · Keystone Industries
Reason: Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IF… - Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and amalgam which helps to…
FDA Device · Class II · 2023-09-20 · Keystone Industries
Reason: A bottle of Copaliner Solvent was inadvertently packaged into a box labeled as Copaliner Varnish (0921526) and sold as Copaliner Varnish (0921526). - Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0…
FDA Device · Class II · 2023-09-20 · Keystone Industries
Reason: The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of the Kit and the IFU enclosed with the kit were correctly l…