FDA Drug Recalls

11,815 recalls · Class II, newest first

Class II · Moderate risk Terminated Nov 14, 2024

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…

Keystone Industries D-0147-2025

Class II · Moderate risk Terminated Nov 14, 2024

Quala Dental Products, Topical Anesthetic Gel, Contains 20% Benzocaine, Net Contents: 1 oz (30g), Gluten Free, Quala Dental…

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…

Keystone Industries D-0146-2025

Class II · Moderate risk Terminated Nov 14, 2024

safco, SensiCaine Ultra, Topical Anesthetic Gel, Contains 20% Benzocaine, 1 oz (29.6 mL), Cherry, NDC 67239-0219-1, Gluten Free…

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…

Keystone Industries NDC 67239-0219-1 D-0145-2025

Class II · Moderate risk Terminated Nov 14, 2024

Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for…

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…

Keystone Industries D-0144-2025

Class II · Moderate risk Terminated Nov 14, 2024

Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma…

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…

Keystone Industries D-0143-2025

Class II · Moderate risk Terminated Nov 14, 2024

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…

Keystone Industries NDC 69634-021-30 D-0142-2025

Class II · Moderate risk Terminated Nov 14, 2024

Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson…

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…

Keystone Industries NDC 50227-1002-3 D-0141-2025

Class II · Moderate risk Terminated Nov 14, 2024

Dental City, Topical Anesthetic Gel, Benzocaine 20%, Net Content: 1 oz. (30 ml), Gluten Free, Manufactured for: Dental City…

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…

Keystone Industries D-0140-2025

Class II · Moderate risk Terminated Nov 14, 2024

Primo, Topical Anesthetic gel, Benzocaine 20%, Net Content: 1 oz. (30g), Gluten Free, Manufactured for: Primo Dental Products…

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…

Keystone Industries D-0139-2025

Class II · Moderate risk Terminated Nov 14, 2024

M&S Dental Supply Co LLC., Topical Anesthetic Gel, Benzocaine 20%, Net Wt. 1 oz. (30ml), Manufactured for: M&S Dental Supply Co…

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…

Keystone Industries D-0138-2025

Class II · Moderate risk Terminated Nov 14, 2024

Gelato, Benzocaine 20% Topical Gel Anesthetic Gel, Net Wt. 1 oz. (30ml), Manufactured by Keystone Industries 480 S. Democrat Rd…

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…

Keystone Industries NDC 68400-352-30 D-0137-2025

Class II · Moderate risk Terminated Nov 14, 2024

Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10…

Reason CGMP Deviations: Released product should have been rejected.

LNK International, Inc. NDC 63981-795-81 D-0115-2025

Class II · Moderate risk Terminated Nov 7, 2024

Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN…

Reason Failed Impurity/Degradation Specifications

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7134-70 D-0050-2025

Class II · Moderate risk Terminated Nov 7, 2024

Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN…

Reason Failed Impurity/Degradation Specifications

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-7135-72 D-0049-2025

Class II · Moderate risk Terminated Nov 6, 2024

BEVACIZUMAB (AVASTIN)1.25mg/0.05mL, Sterile Injection, 0.5 mL Single-Dose Syringe, Rx Only, Repackaged by: Medivant Healthcare…

Reason Lack of Sterility Assurance

Tailstorm Health INC NDC 81483-0041-1 D-0051-2025

Class II · Moderate risk Terminated Nov 1, 2024

Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA…

Reason cGMP Deviations

JR Watkins NDC 72342-100-05 D-0075-2025

Class II · Moderate risk Terminated Oct 25, 2024

Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA…

Reason Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

Lannett Company Inc. D-0112-2025

Class II · Moderate risk Terminated Oct 24, 2024

PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel…

Reason cGMP Deviations

Unexo Life Sciences Private Limited NDC 55758-039-01 D-0072-2025

Class II · Moderate risk Terminated Oct 24, 2024

CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006…

Reason cGMP Deviations

Unexo Life Sciences Private Limited D-0071-2025

Class II · Moderate risk Terminated Oct 24, 2024

JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC…

Reason cGMP Deviations

Unexo Life Sciences Private Limited D-0070-2025

Class II · Moderate risk Terminated Oct 24, 2024

LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099…

Reason cGMP Deviations

Unexo Life Sciences Private Limited D-0069-2025

Class II · Moderate risk Terminated Oct 24, 2024

EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%…

Reason cGMP Deviations

Unexo Life Sciences Private Limited NDC 79903-106-06 D-0068-2025

Class II · Moderate risk Terminated Oct 24, 2024

HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC…

Reason cGMP Deviations

Unexo Life Sciences Private Limited NDC 71101-947-10 D-0067-2025

Class II · Moderate risk Terminated Oct 24, 2024

THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031…

Reason cGMP Deviations

Unexo Life Sciences Private Limited NDC 71101-954-05 D-0066-2025

Class II · Moderate risk Terminated Oct 24, 2024

THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches…

Reason cGMP Deviations

Unexo Life Sciences Private Limited NDC 71101-001-24 D-0065-2025