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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 521–540 of 25000 recalls

Spironolactone Tablets (Sun Pharma) - Foreign Substance (2025)

Presence of foreign substance: identified as aluminum.

Class IIModerate

FDAAug 5, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

PhD Hemostasis Valve (Merit Medical) – manufacturing defect (2025)

Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.

Moderate

FDAAug 4, 2025AL, AK, AZ +47 more• Merit Medical Systems, Inc.

Halyard CPT Basic IR Pack (AVID Medical) – seal compromise (2025)

Potential for open header bag seals, compromising sterility.

Low

FDA

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Aug 4, 2025

Nationwide

• AVID Medical, Inc.

Halyard ENT Pack (AVID Medical) – seal compromise (2025)

Potential for open header bag seals, compromising sterility.

Low

FDAAug 4, 2025Nationwide• AVID Medical, Inc.

Lactated Ringer's Injection (B Braun) - Sterility Concern (2025)

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Class IIModerate

FDAAug 4, 2025Nationwide• B BRAUN MEDICAL INC

Potato Salad (Hans Kissle) – Undeclared Wheat (2025)

Undeclared Gluten

Contains undeclared wheat. The top label identifies the product as potato salad, but the unit contains pasta salad.

Class IIModerate

FDAAug 4, 2025CT, MA, NJ +2 more• Hans Kissle Company, LLC

Sodium Chloride Injection (B Braun) - Sterility Concern (2025)

Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.

Class IIModerate

FDAAug 4, 2025Nationwide• B BRAUN MEDICAL INC

Azurion System (Philips) – power supply issue (2025)

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

Moderate

FDAAug 1, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura Xper X-Ray System (Philips) – component missing (2025)

Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

Low

FDAAug 1, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura System (Philips) – power supply issue (2025)

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

Moderate

FDAAug 1, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Charge Plus Multi-Tools (Leatherman) – Laceration Hazard (2025)

Laceration Risk

This recall involves Leatherman Charge Plus and Charge Plus TTi multi-tools. The Charge Plus multi-tools come in black and stainless-steel colors and with a black MOLLE or black nylon sheath. The Charge Plus TTi multi-tools were sold in a stainless-steel color with a black nylon sheath. The name "Leatherman" is etched on the product.

Moderate

CPSCJul 31, 2025Nationwide• Leatherman Tool Group Inc., of Portland, Oregon

7up Zero Sugar Tropical Soda (Buffalo Rock) – mislabeled product (2025)

Product mislabeled - cans are labeled as Zero Sugar, but contain full sugar product

Class IIModerate

FDAJul 31, 2025AL, FL, GA• Buffalo Rock Company Inc

LinkSymphoKnee System (Waldemar Link) – screw issue (2025)

Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.

Low

FDAJul 31, 2025Nationwide• Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany

Clearview Strep A Kit (Mckesson) – classification error (2025)

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

Low

FDAJul 30, 2025Nationwide• Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233

Epikut Plus Dental Implant (S.I.N. Implant) – storage conditions (2025)

Dental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there may be packaging damage, which could compromise product quality and performance.

Moderate

FDAJul 30, 2025Nationwide• S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil

Fortress Introducer Sheath (Contract Medical) – labeling error (2025)

Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.

Low

FDAJul 30, 2025Nationwide• Contract Medical International GmbH Lauensteiner Str. 37 Dresden Germany

Sodium Bicarbonate Injection (Exela Pharma) – Arsenic Impurities (2025)

Failed Impurities/Degradation Specifications: out of specification results for arsenic in the impurities tested.

Class IIModerate

FDAJul 30, 2025Nationwide• Exela Pharma Sciences LLC

Sucralfate Tablets (Amerisource) – Quality Monitoring Failure (2025)

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

Class IIModerate

FDAJul 29, 2025Nationwide• Amerisource Health Services LLC

Anabolic Research WINN-50 (Dynamic Sports) – sub-potent supplement (2025)

Dietary supplement involved degradation of an ingredient. Product is sub-potent for Vitamin B12 not meeting label claims.

Class IIILow

FDAJul 28, 2025Nationwide• Dynamic Sports Nutrition

10Fore Hemostasis Valve (Merit Medical) – Silicone Ring Defect (2025)

Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.

Moderate

FDAJul 25, 2025Nationwide• Merit Medical Systems, Inc.