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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories Recalls

All product recalls associated with The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories.

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Recall Summary

Total Recalls

1000

Past Year

100

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 101–120 of 2670 recalls

Duloxetine Capsules (Harvard Drug Group) – Nitrosamine Impurity (2025)

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

Class IIModerate

FDAJan 13, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

DxC 500 AU Analyzer (Beckman) – Stability Date Issue (2025)

Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates for assays that were loaded prior to a software upgrade (e.g. 1.3 to 1.4, 1.4 to 1.4.1, etc.). As a result, assays that have expired may still be used for sample processing, leading to inaccurate or erroneous patient test results. The issue only happens on assays loaded before instruments doing upgrades and does not impact new installation. It does not impact the assays loaded after upgrade.

High

FDAJan 10, 2025AL, CA, CO +16 more• BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. No.

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John Deere ZTrak Mowers (Kawasaki) – Fire Hazard (2025)

Fire/Burn Risk

This recall involves John Deere ZTrak Zero Turn Mowers with model numbers Z720E, Z730M, Z740R and Z760R with Kawasaki engines. Model Start Serial Number End Serial Number Z720E 1TC720E****010001 1TC720E****080657 Z730M 1TC730M****010001 1TC730M****080574 Z740R 1TC740R****010001 1TC740R****080462 Z760R 1TC760R****080001 1TC760R****080339

High

CPSCJan 2, 2025Nationwide• Kawasaki Motors Manufacturing Corp. U.S.A. (engine manufacturer), of Maryville, Missouri

Storyteller GXV Hilt (Storyteller) – Frame Structural Issue (2024)

Storyteller Overland, LLC (Storyteller Overland) is recalling certain 2023-2024 GXV HILT vehicles. The metal frames within the housing portion of the vehicle may be improperly grounded.

High

NHTSADec 23, 2024Nationwide• STORYTELLER OVERLAND

Storyteller Beast Mode (Storyteller) – Electrical Issue (2024)

Fire/Burn Risk

Storyteller Overland, LLC (Storyteller Overland) is recalling certain 2024 Beast Mode, Classic Mode, Stealth Mode, and Mystic Mode vehicles. An improperly torqued internal component may cause the secondary alternator to short circuit and overheat.

High

NHTSADec 23, 2024Nationwide• STORYTELLER OVERLAND

Lipoprotein (a) Test (Randox) – 510(k) Compliance Issue (2024)

Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) or PMA.

Moderate

FDADec 20, 2024Nationwide• Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom

Rajbhog Jelebi Jaggery (Rajbhog Distributors) – Undeclared Milk (2024)

Undeclared Milk

Undeclared milk

Class IIModerate

FDADec 20, 2024TX• Rajbhog Distributors TX Inc.

Rajbhog Jelebi Yellow (Rajbhog Distributors) – Undeclared Milk (2024)

Undeclared Milk

Undeclared milk

Class IIModerate

FDADec 20, 2024TX• Rajbhog Distributors TX Inc.

Rajbhog Jelebi Orange (Rajbhog Distributors) – Undeclared Milk (2024)

Undeclared Milk

Undeclared milk

Class IIModerate

FDADec 20, 2024TX• Rajbhog Distributors TX Inc.

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

Karl Storz Endoskope Biopsy Forceps (Karl Storz) – Cleaning Validation Failure (2024)

Due to failure of manual cleaning validation, biopsy and grasping forceps like sterility assurance.

Moderate

FDADec 19, 2024AZ, AR, CA +29 more• Karl Storz Endoscopy

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Cysto-Urethroscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Pediatric Uretero-Renoscope (Karl Storz) – Reprocessing Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

Moderate

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

Stryker Blueprint Mixed Reality Pin Guide (Tornier) – Device Disassembly Risk (2024)

The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.

High

FDADec 18, 2024AK, ID, KY +4 more• Tornier S.A.S. 161 Rue Lavoisier Montbonnot-Saint-Martin France

HemosIL Heparin Calibrators (Instrumentation Laboratory) – Quality Control Problem (2024)

Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.

Moderate

FDADec 18, 2024Nationwide• Instrumentation Laboratory

Dabigatran Etexilate 75mg (Ascend) – Impurity Limit Exceeded (2024)

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

Class IIModerate

FDADec 12, 2024Nationwide• Ascend Laboratories, LLC