Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
20 recalls
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Class II Ongoing
safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Product
- safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry Flavor, 1 oz. (29.6mL), Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60099, Made in USA, NDC 67239-0223-1.
- Lots / codes
- BNZ-001921, Exp 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 150 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0606-2026
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Class II Ongoing
PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Product
- PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Flavor, Manufactured for Pure Life, LLC, Manufactured for PureLife LLC., Carson, CA 90810. NDC 68987-001-30
- Lots / codes
- BNZ-001921, EXP 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 450 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0605-2026
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Class II Ongoing
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Product
- Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30 g), Distributed by Dental City, 3205 Yeager Dr., Green Bay, WI 54311. NDC 69483-001-30
- Lots / codes
- BNZ-001921, Exp 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 450 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0604-2026
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Class II Ongoing
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL), Manufactured for Burkhart Dental Supply, Tacoma, Washington, 98409. NDC: 43498-310-30
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Lots / codes
- BNZ-001917, Exp 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 150 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0603-2026
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Class II Ongoing
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Manufactured for and Distributed by Dental Health Products, Inc, 2614 North Sugar Bush Road, New Franken, WI 54229. NDC 69634-020-30
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Lots / codes
- BNZ-001921, EXP 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 150 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0602-2026
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Class II Ongoing
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavor Net Contents: 1 oz (30 g), Quala Dental Products, Made in USA for NDC Inc., 407 Sanford Road, Le Vergne, TN 37086, NDC 43128-034-30.
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Lots / codes
- BNZ-001921, EXP 04/15/2029
- Distribution
- Nationwide in the USA
- Quantity
- 150 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0601-2026
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Class II Ongoing
Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Contents: 1 oz (3o g), Manufactured for: Pearson Dental Supply Inc., Sylmar, CA 91342 USA, NDC 43305-0009-3.
Reason: Defective container:may contain bottles with incomplete seals
Lots, distribution and details
- Lots / codes
- BNZ-001917, Exp 04/01/2029
- Distribution
- Nationwide in the USA
- Quantity
- 900 units
- Recall started
- May 21, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0600-2026
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Class II Terminated
Optim V, Anti-Itch Cream, Benzocaine 20% & Resorcinol 3% – External analgesic, Net Wt. Peso Neto 1 oz (28g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-300-01, UPC 8 59424 00420 6.
Reason: CGMP Deviations
Lots, distribution and details
- Lots / codes
- Lot SP24A, Exp: 09/30/2026
- Distribution
- DE and NC
- Quantity
- 6,372 Tubes
- Recall started
- April 24, 2025 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0427-2025
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Class II Terminated
Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,
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 inadvertently released and shipped to customers.
Lots, distribution and details
- Lots / codes
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-43619
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0148-2025
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Class II Terminated
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.
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 inadvertently released and shipped to customers.
Lots, distribution and details
- Lots / codes
- Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-35119
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0147-2025
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Class II Terminated
Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental Products, Made in USA for: NDC, Inc, 407 New Sanford Road, La Vergne, TN 37086, www.quala.com
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 inadvertently released and shipped to customers.
Lots, distribution and details
- Lots / codes
- Lot No.: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64419
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0146-2025
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Class II Terminated
safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professi…
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 inadvertently released and shipped to customers.
Lots, distribution and details
- Product
- safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free, Distributed by: Safco Dental Supply Co., Buffalo Grove, IL 60089, Made in USA, For Professional Use Only.
- Lots / codes
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-64119
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0145-2025
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Class II Terminated
Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.
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 inadvertently released and shipped to customers.
Lots, distribution and details
- Lots / codes
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-30619
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0144-2025
-
Class II Terminated
Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.
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 inadvertently released and shipped to customers.
Lots, distribution and details
- Lots / codes
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-29119
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0143-2025
-
Class II Terminated
Health-Tec, Topical Anesthetic Gel, Benzocaine 20%, Made in USA, 1 FL. OZ (29.6 ml), NDC 69634-021-30.
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 inadvertently released and shipped to customers.
Lots, distribution and details
- Lots / codes
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-28119
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0142-2025
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Class II Terminated
Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City, Green Bay, WI 54311, dentalcity.com.
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 inadvertently released and shipped to customers.
Lots, distribution and details
- Lots / codes
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-25119
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0140-2025
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Class II Terminated
Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products, 845 Third Avenue, 6th Floor, New York, NY 10022.
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 inadvertently released and shipped to customers.
Lots, distribution and details
- Lots / codes
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No. 03-13119
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0139-2025
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Class II Terminated
M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co LL, 105-30 101 Avenue, Ozone Park, NY 11416.
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 inadvertently released and shipped to customers.
Lots, distribution and details
- Lots / codes
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone Item No: 03-09619
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0138-2025
-
Class II Terminated
Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd., Gibbstown, NJ 08027, NDC# 68400-352-30.
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 inadvertently released and shipped to customers.
Lots, distribution and details
- Lots / codes
- Lot: BNZ-001646, Exp Date: 11/26/2026, Keystone item No. 03-02319
- Distribution
- Nationwide in the USA and Canada, Dominican Republic, El Salvador, Honduras, and Qatar.
- Quantity
- —
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0137-2025
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Class I Completed
Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736…
Reason: Chemical Contamination: presence of benzene
Lots, distribution and details
- Product
- Americaine, (benzocaine 20%) Benzocaine Topical Anesthetic Spray, Aerosol Can 2 oz (57 G), Dist. by Insight Pharmaceuticals Corp. Tarrytown, NY 10591, USA, A Prestige Consumer Healthcare company. Made in India. NDC 63736-378-02, Can UPC 3 63736 37882 0; Case UPC 1 03 63736 37882 7
- Lots / codes
- Lot # 1A16420, exp. date 01/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 34,704 cans
- Recall started
- December 21, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0236-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.