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FDA Drug Recalls

161 recalls, newest first

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 III · Low risk Terminated Nov 5, 2024

Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick…

Reason Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories NDC 0904-6441-61 D-0045-2025

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

Class II · Moderate risk Terminated Oct 24, 2024

ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches…

Reason cGMP Deviations

Unexo Life Sciences Private Limited D-0064-2025

Class II · Moderate risk Terminated Oct 24, 2024

ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402…

Reason cGMP Deviations

Unexo Life Sciences Private Limited D-0063-2025

Class II · Moderate risk Terminated Oct 24, 2024

ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga…

Reason cGMP Deviations

Unexo Life Sciences Private Limited D-0062-2025

Class II · Moderate risk Terminated Oct 23, 2024

Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02)…

Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Lupin Pharmaceuticals Inc. NDC 68180-591-09 D-0054-2025

Class II · Moderate risk Terminated Oct 23, 2024

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02)…

Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Lupin Pharmaceuticals Inc. NDC 68180-590-09 D-0053-2025

Class II · Moderate risk Terminated Oct 23, 2024

Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02)…

Reason CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

Lupin Pharmaceuticals Inc. NDC 68180-589-09 D-0052-2025

Class II · Moderate risk Terminated Oct 21, 2024

Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277-24

Reason Superpotent Drug: Stability failure for assay at 6 months test time-point.

BLI International, Inc. NDC 53185-277-24 D-0029-2025

Class III · Low risk Terminated Oct 11, 2024

Triamcinolone Acetonide Cream USP, 0.025%, 1 LB (454 g) per jar, Rx Only, Manufactured By Padagis, Minneapolis, MN 55427. NDC…

Reason Subpotent and Superpotent Drug. Out of specification assay results recorded as part of Uniformity of Container test during long-term stability…

Padagis US LLC D-0048-2025

Class II · Moderate risk Terminated Oct 1, 2024

Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Accord…

Reason Failed Impurities/Degradation Specifications.

Accord Healthcare, INC. NDC 16729-288-38 D-0010-2025