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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 401–420 of 21319 recalls

Technetium Tc 99m Mertiatide Kit (Sun Pharmaceutical) – dissolution specification failure (2025)

Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium Tartrate Dihydrate used for the production of Mertiatide.

Class IIModerate

FDASep 3, 2025Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Chlorpromazine Hydrochloride 10mg Tablets (Zydus) – N-Nitroso impurity (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

FDASep 3, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Chlorpromazine Hydrochloride 50mg Tablets (Zydus) – N-Nitroso impurity (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

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Class IIModerate

FDASep 3, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Chlorpromazine Hydrochloride Tablets (Zydus) – CGMP impurity risk (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

FDASep 3, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Chlorpromazine Hydrochloride Tablets (Zydus) – CGMP impurity risk (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

FDASep 3, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Chlorpromazine Hydrochloride Tablets (Zydus) – CGMP impurity risk (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

FDASep 3, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Allura Xper FD20/20 (Philips) – Component Deterioration (2025)

Systems may not perform as intended due to the deterioration of certain internal components (the CMOS battery, hard disk drive, and/or power supply unit). If this deterioration occurs, motorized movements of the system will become unavailable. Manual movements of the stand (longitudinal, transversal and rotational for ceiling mounted systems and rotational for floor mounted systems) and table longitudinal movements remain available. Imaging (X-ray) functionality remains available.

Moderate

FDASep 3, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura Xper FD20/15 (Philips) – Battery Depletion Risk (2025)

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

Moderate

FDASep 3, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Chlorpromazine Hydrochloride 50mg Tablets (Zydus) – N-Nitroso impurity (2025)

CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit

Class IIModerate

FDASep 3, 2025Nationwide• Zydus Pharmaceuticals (USA) Inc

Digital Radiography System (Canon Medical) – ROI Default Issue (2025)

It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the collimated area. If the customer changes the ROI, the collimator blades and static images are adjusted accordingly. However, when the acquisition program is changed, the collimator returns to the default ROI position which may be larger than the specified one, leaving the X-ray area partially covered by the static image. This is a software problem with the SPOT Fluoro program and will not occur if the function is not used.

Moderate

FDASep 2, 2025Nationwide• Canon Medical System, USA, INC.

Sulfamethoxazole and Trimethoprim (Major) – Foreign substance packaging (2025)

Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

Class IIModerate

FDASep 2, 2025Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

NES 0.9mm RX Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Moderate

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES Turbo Elite 0.9mm Catheter (Northeast Scientific) – Sterility Breach (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Moderate

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES Turbo Elite 1.4mm Catheter (Northeast Scientific) – Sterility Breach (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Moderate

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

American Coach American Eagle (American Coach) – Electrical Wiring (2023)

Fire/Burn Risk

REV Recreation Group (REV) is recalling certain 2023-2024 American Coach American Tradition, 2023-2026 American Eagle, and American Dream, and 2025-2026 Fleetwood Palisade recreational vehicles. The waste tank macerator fuse may overheat, causing the fuse housing to melt.

High

NHTSAAug 29, 2025Nationwide• AMERICAN COACH

NES 1.4mm Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Moderate

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

Optiflux Dialyzer (Fresenius) – Cap Configuration (2025)

To provide further information to the user to ensure proper use of the medical device. the caps had been changed from a threaded version to a press-on version whereby the user must press the caps firmly onto the dialyzer to securely affix the cap.

Low

FDAAug 29, 2025Nationwide• Fresenius Medical Care Holdings, Inc.

NES 1.7mm RX Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Moderate

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES Turbo Elite 2.0mm Catheter (Northeast Scientific) – Sterility Breach (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Moderate

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.

NES 1.7mm Laser Atherectomy Catheter (Northeast Scientific) – Sterility Concern (2025)

Potential for breaches in the sterile barrier packaging, compromising sterility assurance.

Moderate

FDAAug 29, 2025Nationwide• Northeast Scientific Inc.