Keystone Industries recalls
Every recall we track for Keystone Industries — 23 in all, from 2023–2026 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
Recalls from Keystone Industries dropped to zero in 2025 (0, down from 13 in 2024).
All FDA recall records for Keystone Industries since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 1 | 2 | 0 | 3 |
| 2024 | 0 | 1 | 9 | 3 | 13 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 7 | 0 | 7 |
Most common reasons for Keystone Industries recalls
What to do if you have a recalled Keystone Industries product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Keystone Industries recalls
6 shown- Lower riskDrug
Keystone Industries recalls DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental
Keystone Industries recalls DHP Topical Anesthetic Gel (Benzocaine 20%) due to potential incomplete seals in containers. This may lead to product leakage or contamination. Affected units have NDC 69634-020-30 and expire 04/15/2029.
Keystone IndustriesMay 21, 2026 - Lower riskDrug
Keystone Industries recalls Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S.
Keystone Industries recalls Gelato 20% Benzocaine Topical Gel due to CGMP deviations where mixing vessel scratches were found during routine inspection but product was inadvertently shipped.
Keystone IndustriesNov 14, 2024 - Use cautionDrug
Keystone Industries recalls Perio Maintenance Rinse 0.63% Stannous Fluoride Concentrated Solution, Rx Only, Net Wt. 10 oz. (283.5 g) pumps, Mint
Keystone Industries recalls Perio Maintenance Rinse (Mint) because the drug may be subpotent. Check lot numbers PVC-003015 and PVC-003061.
Keystone IndustriesOct 17, 2024 - Lower riskMedical device
Keystone Industries recalls KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards,
Keystone Industries recalls KeySplint Hard Clear resin bottles due to incorrect instructions for use. This could lead to improper fabrication of dental appliances if users follow the wrong instructions.
Keystone IndustriesNov 20, 2023 - Lower riskMedical device
Keystone Industries recalls Keystone Bosworth Copaliner Cavity Varnish .5oz (14 ml)- Intended to provide a marginal seal between the dentin and
Keystone Industries recalls Copaliner Varnish (0921526) due to accidental inclusion of Copaliner Solvent in packaging. This could cause improper use in dental procedures.
Keystone IndustriesJul 21, 2023 - Use cautionMedical device
Keystone Industries recalls Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry
Keystone Industries recalls Henry Schein Hard Line Chairside Reline Kits due to mislabeling on the outer box. Check your kit details.
Henry ScheinApr 10, 2023
Keystone Industries recall questions
How many recalls has Keystone Industries had?
23 recalls from Keystone Industries are on record with U.S. safety agencies, from 2023–2026 (20 drug, 3 medical device).
What is the most recent Keystone Industries recall?
Keystone Industries recalls DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental, dated May 21, 2026. Every Keystone Industries recall is listed on this page, newest first.
Why are Keystone Industries products recalled?
The most common reasons on record: Defective container:may contain bottles with incomplete seals (7).
What should I do if I have a recalled Keystone Industries product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Keystone Industries recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.