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Breckenridge Pharmaceutical, Inc

Breckenridge Pharmaceutical, Inc Recalls

All product recalls associated with Breckenridge Pharmaceutical, Inc.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

Most Recent

Jan 2026

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 2221–2240 of 21320 recalls

Duloxetine Capsules (Breckenridge) – Impurity Concern (2024)

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

Class IIModerate

FDAMay 17, 2024Nationwide• Breckenridge Pharmaceutical, Inc

Abbott Proclaim Plus 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

High

FDAMay 16, 2024Nationwide• Abbott Medical

Abbott Proclaim XR 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

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High

FDAMay 16, 2024Nationwide• Abbott Medical

Abbott Liberta RC Pulse Generator (Abbott Medical) – System Deactivation (2024)

Deep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will recur approximately every 50 days thereafter. This unexpected lost of stimulation may result in loss of therapy.

High

FDAMay 16, 2024Nationwide• Abbott Medical

US AquaA 900H Water Purifier (Fresenius) – Concentrate Flow Error (2024)

Concentrate Flow was exceeding the maximum 19.9 bar set point. The standard default set point range is between 4 and 18.Error message (F020104, "concentrate pressure alarm limit exceeded") concentrate pressure is too high and stops the dialysis water supply.

High

FDAMay 16, 2024Nationwide• Fresenius Medical Care Holdings, Inc.

Abbott Proclaim 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

High

FDAMay 16, 2024Nationwide• Abbott Medical

Abbott Proclaim DRG Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

High

FDAMay 16, 2024Nationwide• Abbott Medical

Abbott Proclaim XR 5 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

High

FDAMay 16, 2024Nationwide• Abbott Medical

Philips Allura Xper FD20 System (PHILIPS) – Brake Engagement Problem (2024)

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

High

FDAMay 16, 2024OK• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

BIOFIRE FILMARRAY GI Panel (BioFire) – False Positive Results (2024)

Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.

Moderate

FDAMay 16, 2024Nationwide• BioFire Diagnostics, LLC

TourniKwik Tourniquet Set (Medtronic) – Component Placement Error (2024)

Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.

Low

FDAMay 16, 2024Nationwide• Medtronic Perfusion Systems

Philips Allura Xper FD10 System (PHILIPS) – Brake Engagement Issue (2024)

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

High

FDAMay 16, 2024OK• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Abbott Proclaim 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

High

FDAMay 16, 2024Nationwide• Abbott Medical

Proclaim 7 Elite Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

High

FDAMay 16, 2024Nationwide• Abbott Medical

Estradiol Patch (Zydus) – Specification Failure (2024)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMay 16, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Estradiol Patch (Zydus) – Specification Failure (2024)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMay 16, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Proclaim 5 Elite Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

High

FDAMay 16, 2024Nationwide• Abbott Medical

Philips Allura Xper FD20 System (PHILIPS) – Brake Engagement Problem (2024)

When Software upgrade 8.1.100 is installed on an Allura Xper with an AD7NT (non tilt) table, the pivot brake does not engage. This issue may cause unexpected movements of the table.

High

FDAMay 16, 2024OK• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Inspire Model 3028 Pulse Generator (Inspire Medical) – Electrical Leakage (2024)

There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision surgery to replace the IPG,

High

FDAMay 16, 2024Nationwide• Inspire Medical Systems Inc.

Abbott Proclaim Plus 7 Pulse Generator (Abbott Medical) – Service Life Concern (2024)

The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.

High

FDAMay 16, 2024Nationwide• Abbott Medical