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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 521–540 of 4747 recalls

Mesalamine Delayed-Release Tablets (Sun Pharmaceutical) – Microbial Contamination (2024)

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Fexofenadine Hydrochloride Tablets 180mg (Sun Pharmaceutical) – Microbial Contamination (2024)

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

Class IIModerate

FDAJan 18, 2024Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Phenoxybenzamine Hydrochloride Capsules (Amneal) – Impurity Specification (2024)

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

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Class IIModerate

FDAJan 15, 2024Nationwide• Amneal Pharmaceuticals of New York, LLC

Apollo Onyx Delivery Microcatheter (Micro Therapeutics) – Indications Mismatch (2024)

European version of microcatheter were distributed within US which contain a different "Indications for Use".

FDAJan 11, 2024Nationwide• Micro Therapeutics, Inc.

Fosaprepitant Injection (BE Pharmaceuticals) – Sterility Failure (2024)

Lack of Sterility Assurance: Aseptic process simulation failure.

Class IIModerate

FDAJan 10, 2024Nationwide• BE PHARMACEUTICALS AG

Budesonide Tablets (Teva) – Failed Dissolution (2024)

Failed Dissolution Specifications

Class IIModerate

FDAJan 8, 2024Nationwide• Teva Pharmaceuticals USA, Inc

Rifampin Capsules 150mg (Lupin) – Subpotent Drug (2024)

Subpotent Drug and Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 5, 2024Nationwide• Lupin Pharmaceuticals Inc.

Rifampin Capsules 300mg (Lupin) – Subpotent Drug (2024)

Subpotent Drug and Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 5, 2024Nationwide• Lupin Pharmaceuticals Inc.

Fluocinolone Acetonide Oil (Glenmark) – Failed Specifications (2024)

Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol

Class IIModerate

FDAJan 4, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Zenzedi Tablets (Azurity) – Label Mix-up (2024)

Labeling: Label Mix-up

Class IHigh

FDAJan 4, 2024Nationwide• Azurity Pharmaceuticals, Inc.

Cefixime Suspension (Lupin) – Failed Impurities (2024)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAJan 3, 2024Nationwide• Lupin Pharmaceuticals Inc.

Divalproex Sodium Extended-Release Tablets (Amneal) – Dissolution Failure (2023)

Failed dissolution specifications

Class IIModerate

FDADec 26, 2023Nationwide• Amneal Pharmaceuticals of New York, LLC

Americaine Benzocaine Spray (Insight) – Benzene Contamination (2023)

Chemical Contamination: presence of benzene

Class IHigh

FDADec 21, 2023Nationwide• Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company

Desloratadine Tablets (Lupin) – Impurity Limit Exceeded (2023)

CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.

Class IIModerate

FDADec 20, 2023Nationwide• Lupin Pharmaceuticals Inc.

IgM Total Test (Siemens) – Potential Negative Bias (2023)

Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.

FDADec 15, 2023Nationwide• Siemens Healthcare Diagnostics, Inc.

Pneumonia Panel Plus (BioFire) – False Positive Risk (2023)

Their is a potential for false positive results when using Pneumonia panel.

FDADec 14, 2023Nationwide• BioFire Diagnostics, LLC

Pneumonia Panel (BioFire) – False Positive Risk (2023)

Their is a potential for false positive results when using Pneumonia panel.

FDADec 14, 2023Nationwide• BioFire Diagnostics, LLC

Sertraline Tablets (Legacy) – Product Comingling Risk (2023)

CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.

Class IIModerate

FDADec 11, 2023AR, CA• Legacy Pharmaceutical Packaging LLC

Eprontia Topiramate Solution (Azurity) – Impurity Specification (2023)

Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.

Class IIILow

FDADec 8, 2023Nationwide• Azurity Pharmaceuticals, Inc.

Liothyronine Sodium Tablets (Sun Pharma) – Impurity Concerns (2023)

Failed Impurities/Degradation Specifications

Class IIModerate

FDADec 4, 2023Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC