Keystone Industries
Complete recall history across all FDA and CPSC categories — 16 total recalls
Recall Summary
Keystone Industries appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (13)
FDA drug safety enforcement actions by Keystone Industries
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 14, 2024 | Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml... | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Nov 14, 2024 | Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 m... | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Nov 14, 2024 | Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada. | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Nov 14, 2024 | M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 ... | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Nov 14, 2024 | Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use... | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Nov 14, 2024 | Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Glut... | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Nov 14, 2024 | Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29... | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Nov 14, 2024 | Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 m... | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Nov 14, 2024 | safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 o... | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Nov 14, 2024 | Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net C... | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Nov 14, 2024 | Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (2... | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Nov 14, 2024 | Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manu... | CGMP deviations: the bulk product was rejected by the Quality Unit after rout... | Class II |
| Oct 17, 2024 | Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Onl... | Subpotent Drug | Class II |
Device Recalls (3)
FDA medical device enforcement actions by Keystone Industries
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 20, 2023 | KeySplint Hard Clear - Indicated for the fabrication of orthodontic and denta... | Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged ... | Class II |
| Jul 21, 2023 | Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide ... | A bottle of Copaliner Solvent was inadvertently packaged into a box labeled a... | Class II |
| Apr 10, 2023 | Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relinin... | The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
Explore More Recalls
Search recalls by category, state, reason, or firm across all our databases.