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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 1121–1140 of 21319 recalls

Duloxetine Capsules 30mg (Breckenridge) – Nitrosamine Impurity (2025)

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

Class IIModerate

FDAFeb 28, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Carvedilol Tablets 6.25mg (Glenmark) – Nitrosamine Risk (2025)

CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit

Class IIModerate

FDAFeb 28, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

FilmArra Pneumonia Panel (BioFire) – Test Result Reliability (2025)

Increased risk of control failures and false negative test results with multiplexed nucleic acid test.

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Moderate

FDAFeb 27, 2025Nationwide• BioFire Diagnostics, LLC

Da Vinci 5 (Intuitive Surgical) – Foot Tray Pedal Failure (2025)

Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed

Moderate

FDAFeb 26, 2025Nationwide• Intuitive Surgical, Inc.

Hippo 072 Aspiration System (Qapel) – Catheter Tip Defect (2025)

Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.

High

FDAFeb 26, 2025AL, AZ, CA +26 more• Qapel Medical Inc.

Blue Hawaiian Beverage Concentrate (Paletas) – undeclared color (2025)

Undeclared Allergen

Undeclared Red #3

Class IIILow

FDAFeb 26, 2025AZ, NM, TX +1 more• Paletas Ice Cream, LLC

Zenition 70 (Philips) – Radiation Emission Risk (2025)

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

High

FDAFeb 25, 2025Nationwide• Philips North America Llc

Zenition 50 (Philips) – Radiation Emission Risk (2025)

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

High

FDAFeb 25, 2025Nationwide• Philips North America Llc

Veradius Unity (Philips) – Radiation Emission Risk (2025)

A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.

High

FDAFeb 25, 2025Nationwide• Philips North America Llc

Metformin Extended-Release 500mg (A-S Medication) – Foreign Tablets (2025)

Presence of Foreign Tablets/Capsules.

Class IIModerate

FDAFeb 25, 2025Nationwide• A-S Medication Solutions LLC

Prasugrel Tablets 5mg (Mylan) – Dissolution Failure (2025)

Failed Dissolution Specifications - low dissolution results

Class IIModerate

FDAFeb 25, 2025Nationwide• MYLAN PHARMACEUTICALS INC

Checkpoint Guardian Lead (Checkpoint Surgical) – Adhesive Encapsulation Fault (2025)

Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.

Moderate

FDAFeb 24, 2025Nationwide• Checkpoint Surgical Inc

Livalo 4mg (Kowa) – Foreign Tablets (2025)

Presence of foreign tablets/capsules

Class IIILow

FDAFeb 24, 2025OH, PA, TX• Kowa Pharmaceuticals America

Zapzyt Acne Treatment Gel (Denison) – Benzene Contamination (2025)

Chemical Contamination: Presence of benzene.

Class IIModerate

FDAFeb 24, 2025Nationwide• Denison Pharmaceuticals, LLC

Helix Elite Influenza Standard (Microbiologics) – RSV Target Issue (2025)

The RSV target may give a late Ct value and could potentially not pass QC.

Moderate

FDAFeb 20, 2025Nationwide• Microbiologics Inc

Helix Elite SARS-CoV-2 Standard (Microbiologics) – Cell Target Delay (2025)

The A549 human cell target (human cells for sample adequacy control) may give a late Ct value.

Moderate

FDAFeb 20, 2025Nationwide• Microbiologics Inc

IVX Station Transfer Set (Omnicell) – Premature Deployment (2025)

IVX Station Reconstitution Transfer Sets were shipped in advance of the IVX Station upgrade and not intended for clinical use but are engineering devices intended for use during set up and system calibration. The items were not shipped in a validated packing configuration and sterility cannot be ensured.

Moderate

FDAFeb 20, 2025AL, IN• Omnicell, Inc.

Phenylephrine Sodium Chloride (Central Admixture) – Particulate Matter (2025)

Presence of Particulate Matter

Class IHigh

FDAFeb 20, 2025Nationwide• Central Admixture Pharmacy Services, Inc.

Revolution CT System (GE Medical) – Potential System Issue (2025)

GE HealthCare has become aware of a potential issue on certain Revolution CT and Revolution Apex series CT systems (please see affected product details and the Appendix) that can result in coolant fluid (glycol) leaking onto the floor near the base of the gantry. The fluid is visible as it has a blue color. It is not corrosive and is not at a harmful temperature. However, there is a potential for injury if the fluid is not noticed and a person slips and/or falls.

Moderate

FDAFeb 18, 2025Nationwide• GE Medical Systems, LLC

Revolution CT ES System (GE Medical) – Potential System Issue (2025)

Moderate

FDAFeb 18, 2025Nationwide• GE Medical Systems, LLC