Benzocaine recalls

The FDA has published 18 recalls involving Benzocaine since 2013. The latest was reported on 24 Jun 2026. Most were for packaging defects. Keystone Industries has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls18since 2013

Last 12 months7reported

Class I16% of total

Ongoing7latest 24 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 4 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 7 0 0Aug 0 0

Severity split

Class I 1 6%Class II 16 89%Class III 1 6%

Why benzocaine is recalled

Companies

Keystone Industries1161%
KRS Global Biotechnology211%
Aidapak Services211%
Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare16%
The Mentholatum16%
Cetylite Industries16%

Brands

By year

2026739%
2024528%
202016%
2018211%
2014211%
201316%

Ongoing benzocaine recalls

7 active

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS II	Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recalledPearson Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	safco SensiCaine-Ultra (20% Benzocaine) recalled by Keystone IndustriesSafco Sensicaine Ultra Topical Anesthetic Gel	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	Dental City Topical Anesthetic Gel, Benzocaine recalledDental City Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor recalledBurkhart Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	Quala Dental Products, Topical Anesthetic Gel recalledQuala Topical Anesthetic Gel	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	PureLife, Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recalledPurelife Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide

All benzocaine recalls, newest first

18 total

Reported	Class	Recall	Company	Reason	Where
24 Jun 2026Drug	CLASS II	Pearson Quality Topical Anesthetic Gel (20% Benzocaine) recalledPearson Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	safco SensiCaine-Ultra (20% Benzocaine) recalled by Keystone IndustriesSafco Sensicaine Ultra Topical Anesthetic Gel	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	Dental City Topical Anesthetic Gel, Benzocaine recalledDental City Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor recalledBurkhart Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	Quala Dental Products, Topical Anesthetic Gel recalledQuala Topical Anesthetic Gel	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	PureLife, Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recalledPurelife Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide
24 Jun 2026Drug	CLASS II	DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor recalledHealth-tec Topical Anesthetic	Keystone Industries	Packaging Defects	Nationwide
25 Dec 2024Drug	CLASS II	Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine recalledPatterson Dental Topical Anesthetic	Keystone Industries	Manufacturing (CGMP) Deviations	Nationwide
25 Dec 2024Drug	CLASS II	Health-Tec, Topical Anesthetic Gel, Benzocaine recalledHealth-tec Topical Anesthetic	Keystone Industries	Manufacturing (CGMP) Deviations	Nationwide
25 Dec 2024Drug	CLASS II	safco, SensiCaine Ultra, Topical Anesthetic Gel recalledSafco Sensicaine Ultra Topical Anesthetic Gel	Keystone Industries	Manufacturing (CGMP) Deviations	Nationwide
25 Dec 2024Drug	CLASS II	Gelato, Benzocaine 20% Topical Gel Anesthetic Gel recalledGelato Topical Anesthetic	Keystone Industries	Manufacturing (CGMP) Deviations	Nationwide
24 Jan 2024Drug	CLASS I	Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic recalledAmericaine	Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare	Benzene	Nationwide
2 Sep 2020Drug	CLASS III	Red Cross Oral Pain (Oral Anesthetic benzocaine 20%) recalledRed Cross Oral Pain Relief	The Mentholatum	Packaging Defects	Nationwide
17 Jan 2018Drug	CLASS II	Benzocaine 20%, Lidocaine 8%, Tetracaine 4% Topical Cream recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
17 Jan 2018Drug	CLASS II	Benzocaine 20%, Lidocaine 6%, Tetracaine 4% Cream recalled	KRS Global Biotechnology	Packaging Defects	Nationwide
22 Jan 2014Drug	CLASS II	Benzocaine/Menthol Lozenge, 15 mg/3.6 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
22 Jan 2014Drug	CLASS II	Benzocaine/Menthol, Lozenge, 15 mg/2.6 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states
4 Dec 2013Drug	CLASS II	Cetacaine Liquid Topical Anesthetic recalled by Cetylite IndustriesCetacaine Anesthetic	Cetylite Industries	Potency & Assay	Nationwide

Should you stop taking Benzocaine?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.