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SUN PHARMACEUTICAL INDUSTRIES INC

SUN PHARMACEUTICAL INDUSTRIES INC Recalls

All product recalls associated with SUN PHARMACEUTICAL INDUSTRIES INC.

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Recall Summary

Total Recalls

1000

Past Year

1000

Class I (Serious)

127

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 1321–1340 of 25000 recalls

Morphine Sulfate Tablets (Sun Pharma) – Dissolution Failure (2025)

Failed Dissolution Specifications

Class IIModerate

FDAFeb 6, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Laparoscopy Pack (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Moderate

FDAFeb 6, 2025Nationwide• American Contract Systems Inc

Laceration Tray (American Contract) – sterilization uncertainty (2025)

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Moderate

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FDA

Feb 6, 2025

Nationwide

• American Contract Systems Inc

Rotarex Atherectomy System (Bard) – catheter breakage (2025)

Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.

High

FDAFeb 5, 2025Nationwide• Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438

Samsung SDI Battery Pack (Samsung SDI) – vehicle battery (2025)

Fire/Burn Risk

Samsung SDI Co., Ltd. (Samsung SDI) is recalling certain high voltage battery packs, installed in certain Chrysler (FCA US, LLC) vehicles (NHTSA recalls 24V-720 and 24E-080), Volkswagen/Audi vehicles (NHTSA recall 24V-898) and Ford vehicles (NHTSA recall 24V-954). Please see the attached document for a list of affected part numbers. The high voltage batteries may fail.

High

NHTSAFeb 5, 2025Nationwide• SAMSUNG SDI

MEDITECH Expanse Software (Medical Information Technology) – data removal (2025)

Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.

Low

FDAFeb 5, 2025Nationwide• Medical Information Technology, Inc.

IntelePACS Software (Intelerad) – image calculation error (2025)

A software application that receives digital images and data from various sources has a bug in specific software versions that will calculate the Standard Uptake Value (SUV) incorrectly for PET/CT studies acquired on the days of Daylight Savings Time (DST); only on dates in which DST transition occurs; all other dates are unaffected. An incorrect SUV may lead to an incorrect diagnosis.

High

FDAFeb 5, 2025Nationwide• INTELERAD MEDICAL SYSTEMS INCORPORATED 800, Boul. de Maisonneuve Est 12th floor Montreal Canada

Crani Pack (American Contract) – sterilization uncertainty (2025)

During an internal investigation, ACS was unable to confirm that the CODMAN component achieved the required Sterility Assurance Level and therefore is not suitable for sterilization according to ACS procedures.

Moderate

FDAFeb 4, 2025MI• American Contract Systems Inc

IsoLoc Prostate Balloon (Angiodynamics) – mislabeled volume (2025)

Product is mislabeled with the incorrect fill volume.

Low

FDAFeb 4, 2025Nationwide• Angiodynamics, Inc.

TBS iNsight (Medimaps) – calculation variability (2025)

Potential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines.

Low

FDAFeb 3, 2025AL, AZ, CA +21 more• Medimaps Group Fongit Chemin des Aulx 18 Plan-les-Ouates Switzerland

Optima MR360 MRI System (GE Healthcare) – SAR monitoring (2025)

For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enable a scan to proceed earlier than intended. If resumed by the operator, such a scan can result in potential excessive tissue heating, especially if the patient is in contact with a conductive material or has an implant.

Moderate

FDAJan 31, 2025Nationwide• GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China