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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

304

Class I (Serious)

Most Recent

Nov 2025

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 481–500 of 4747 recalls

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

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

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

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

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.

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

VITROS Performance Verifier II (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.

FDAFeb 27, 2024Nationwide• Ortho-Clinical Diagnostics

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

FDAFeb 27, 2024Nationwide• Ortho-Clinical Diagnostics

Skull Anchor Key (Navinetics) – Attachment Failure (2024)

Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of the localizer is typically accomplished by fully screwing in the four thumbscrews of the localizer into the threaded holes found on the top surface of the Skull Anchor Key.

FDAFeb 26, 2024Nationwide• Navinetics Inc

LeadCare II Blood Test (Magellan) – Calibration Mislabeling (2024)

Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.

FDAFeb 23, 2024Nationwide• Magellan Diagnostics, Inc.

Clindamycin Phosphate Solution (Contract Pharmaceuticals) – container defect (2024)

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Class IIILow

FDAFeb 20, 2024Nationwide• Contract Pharmaceuticals Limited Canada

Clindamycin Phosphate Solution (Contract Pharmaceuticals) – container defect (2024)

Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.

Class IIILow

FDAFeb 20, 2024Nationwide• Contract Pharmaceuticals Limited Canada

Oseltamivir Phosphate Suspension (Amneal) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications: Out-of-specification test results.

Class IIModerate

FDAFeb 13, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

Mercaptopurine Tablets (Stason) – Dissolution Specification Failure (2024)

Failed Dissolution Specifications: results slightly under spec at at 9-months.

Class IIILow

FDAFeb 9, 2024Nationwide• Stason Pharmaceuticals, Inc.

HydrALAZINE Tablets (Harvard Drug) – Impurity Concern (2024)

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

Class IIModerate

FDAFeb 9, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

DCA HbA1c Reagent Kit (Siemens) – Test Result Bias (2024)

The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that erroneous test results could be reported and potentially lead to incorrect patient management of glucose control. A positive bias may be observed with eleven HbA1c affected lots. Positive bias was observed when the performance of these five HbA1c lots was compared to NGSP pooled patient target-value assigned samples and the maximum bias observed was 19%.

FDAFeb 7, 2024Nationwide• Siemens Healthcare Diagnostics, Inc.

Voriconazole Oral Suspension (Lupin) – Labeling Error (2024)

Labeling: Incorrect or Missing Package Insert

Class IIModerate

FDAFeb 5, 2024IL, NJ, OH• Lupin Pharmaceuticals Inc.

Mesalamine Capsules (Sun Pharmaceutical) – Dissolution Failure (2024)

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDAFeb 5, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

TING Tolnaftate Spray (Insight) – Benzene Contamination (2024)

Chemical Contamination; presence of benzene.

Class IHigh

FDAFeb 1, 2024Nationwide• Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

VITROS XT 3400 System (Ortho) – QC Baseline Defect (2024)

A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

BCID2 Panel (BioFire) – False Positive Results (2024)

Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums

FDAJan 26, 2024Nationwide• BioFire Diagnostics, LLC

FilmArray GI Panel (BioFire) – False Norovirus Results (2024)

Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.

FDAJan 26, 2024Nationwide• BioFire Diagnostics, LLC

VITROS 3600 System (Ortho) – QC Baseline Defect (2024)

FDAJan 26, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.