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Lupin Pharmaceuticals Inc.

Lupin Pharmaceuticals Inc. Recalls

All product recalls associated with Lupin Pharmaceuticals 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 1821–1840 of 21319 recalls

Cefixime Oral Suspension (Lupin) – Subpotent Drug Formulation (2024)

Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.

Class IIModerate

FDAAug 21, 2024Nationwide• Lupin Pharmaceuticals Inc.

Cortera Spinal Fixation Screw (XTANT) – Implant Marking Issue (2024)

Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.

Moderate

FDAAug 21, 2024Nationwide• XTANT Medical Holdings, Inc

Vanta Neurostimulator (Medtronic) – Battery Life Concern (2024)

Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than anticipated surgical replacements.

1...90 919293 94...1066

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Moderate

FDAAug 21, 2024Nationwide• Medtronic Neuromodulation

ADVIA Centaur aTPO Assay (Siemens) – Result Bias (2024)

Laceration Risk

Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the Atellica IM analyzer.

Moderate

FDAAug 21, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Acceava Strep A Test (Cypress) – Licensing Shipment Error (2024)

Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

Low

FDAAug 20, 2024Nationwide• Cypress Medical Products LLC

Miami J Select Collar (Ossur) – Adhesive Hook Issue (2024)

Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to them gradually peeling off with repeated doffing, possibly leading to reduced immobilization of the cervical spine.

Moderate

FDAAug 20, 2024AL, AK, AZ +36 more• Ossur H F Grjothals 5 Reykjavik Iceland

BinaxNOW Strep A Test (Cypress) – Licensing Shipment Error (2024)

Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to purchase such devices.

Low

FDAAug 20, 2024Nationwide• Cypress Medical Products LLC

Blue Diamond Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

MONARCH Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

BlueFIRE Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

IntelliSystem Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

basixTOUCH Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

Selenia Dimensions (Hologic) – Software Image Quality Issue (2024)

Identified an issue with Selenia Dimensions 1.12.0 and 3Dimensions 2.3.0 system software when used in combination with C-View software in which the quality of the final C-View synthesized 2D image is impacted and may appear blurry and result in misdiagnosis with the possibility being a false negative diagnosis

High

FDAAug 19, 2024Nationwide• Hologic Inc

basixSKY Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

StabiliT TOUCH Syringe (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

Custom Inflation Kit (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.

DiamondTOUCH Inflation Device (Merit Medical) – Sterile Barrier Breach (2024)

Inflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens which could lead to infection.

High

FDAAug 19, 2024Nationwide• Merit Medical Systems, Inc.