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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)

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 2661–2680 of 21320 recalls

Febuxostat 80mg (Sun Pharma) – microbial contamination (2024)

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIModerate

FDAMar 4, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Febuxostat 40mg (Sun Pharma) – microbial contamination (2024)

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Class IIModerate

FDAMar 4, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

HeNe Laser System (Pacific LaserTech) – Key Control Noncompliance (2024)

These laser products fail to comply with 21 CFR 1040.10(f)(4) Key control which requires, Each laser system classified as a Class IIIb or IV laser product shall incorporate a key-actuated master control. The key shall be removable and the laser shall not be operable when the key is removed. , because while the laser is switched on, the key can be removed from the key switch. The correction is replacement with a key switch that captures the key when in the on position.

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High

FDAMar 1, 2024Nationwide• PACIFIC LASERTECH, LLC

VITROS Anti HBs Calibrators (Ortho-Clinical) – Signal Reduction Risk (2024)

Potential for positively biased results due to signal reduction over shelf life.

Moderate

FDAMar 1, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Triangle Tip Electrosurgical Knives (Olympus) – Breakage Warning (2024)

Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which details critical specifications regarding electrosurgical unit compatibility and output due to reports of serious injury

Moderate

FDAMar 1, 2024Nationwide• Olympus Corporation of the Americas

HeNe Laser System (Pacific LaserTech) – Key Control Noncompliance (2024)

High

FDAMar 1, 2024Nationwide• PACIFIC LASERTECH, LLC

HeNe Laser System (Pacific LaserTech) – Key Control Noncompliance (2024)

High

FDAMar 1, 2024Nationwide• PACIFIC LASERTECH, LLC

Hydrogen Peroxide Mouthwash (Nutraceutical) - poisoning risk (2024)

This recall involves Heritage Store Hydrogen Peroxide Mouthwash in Wintermint and Eucalyptus Mint flavors. The bottles are a dark opaque brown with a white lid. The pink and white label on the front of the bottles displays the Heritage Store logo, product name and flavor. All lots are included in the recall.

High

CPSCFeb 29, 2024Nationwide• Nutraceutical Corporation, of Salt Lake City, Utah

BD Phoenix NMIC-306 Panel (Becton Dickinson) – Drug Cross Contamination (2024)

Products were found to have confirmed drug cross contamination prior to release may lead to incorrect, inadequate, or absent antibiotic treatment or delay in results

Moderate

FDAFeb 29, 2024Nationwide• Becton Dickinson & Co.

BD Phoenix Yeast ID Panel (Becton Dickinson) – Substrate Misplacement (2024)

Esculin, a substrate used in other panels and normally in A16 well, was found in A17 well. A17 in yeast panels is supposed to be an empty well and is not a part of the normal ID evaluation. However, A17 is checked for fluorescence and if anything is found, the system will abort the panel with the message Fluorescent interference has been detected. Esculin is expected to trigger this fluorescence and test cancellation.

Moderate

FDAFeb 29, 2024Nationwide• Becton Dickinson & Co.

Mariner RDX MIS Polyaxial Head (SeaSpine) – Screw Head Threading Risk (2024)

Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

Moderate

FDAFeb 28, 2024CA, CO, FL +1 more• SEASPINE ORTHOPEDICS CORPORATION

Patient Information Center iX (Philips) – Mobile App Ringtone Issue (2024)

It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.

Low

FDAFeb 28, 2024Nationwide• Philips North America

CareEvent Event Management System (Philips) – Mobile App Ringtone Issue (2024)

It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.

Low

FDAFeb 28, 2024Nationwide• Philips North America

CADD-Solis Ambulatory Pumps (Smiths Medical) – Software Malfunction (2024)

CADD-Solis Ambulatory Infusion Pumps, with software versions before v4.3, may have the following issues:1. Upstream Occlusion, 2. Stop and Power Keys Unresponsive, 3. Manual Mode Air Detector, 4. Single Bubble Air Detection, 5. Error Codes Not Displayed at Power Up, 6. Audible Alarm, 7. Low Sensitivity Air in Line Detection Threshold, 8. PharmGuard Server Password. Smiths Medical corrected many of the issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent CADD software (v4.3 - 2023) installed on your pumps.

Moderate

FDAFeb 27, 2024Nationwide• Smiths Medical ASD Inc.

Trident II PSL Cluster (Howmedica) – Acetabular Shell Surface Defect (2024)

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

TRIDENTII HEMI CLUSTER48D (Howmedica Osteonics) – Excessive Shell Deburring (2024)

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

VITROS Performance Verifier I (Ortho-Clinical Diagnostics) – Diluent Mismatch (2024)

The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.

Moderate

FDAFeb 27, 2024Nationwide• Ortho-Clinical Diagnostics

TRIDENTII PSL CLUSTER50D (Howmedica Osteonics) – Excessive Shell Deburring (2024)

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

Trident II Hemi Cluster (Howmedica) – Acetabular Shell Surface Defect (2024)

The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Low

FDAFeb 27, 2024Nationwide• Howmedica Osteonics Corp.

VITROS Performance Verifier II (Ortho-Clinical Diagnostics) – Diluent Mismatch (2024)

Moderate

FDAFeb 27, 2024Nationwide• Ortho-Clinical Diagnostics