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Glenmark Pharmaceuticals Inc., USA

Glenmark Pharmaceuticals Inc., USA Recalls

All product recalls associated with Glenmark Pharmaceuticals Inc., USA.

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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 2281–2300 of 21320 recalls

Rizatriptan Tablets (Glenmark) – Impurity Concern (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 13, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Vasopressin Injection (American Regent) – Subpotent Product (2024)

Subpotent product in addition to having out-of-specification results for impurities.

Class IIModerate

FDAMay 13, 2024Nationwide• American Regent, Inc.

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

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Class II

Moderate

FDAMay 13, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Duloxetine Capsules (Golden State) – Nitrosamine Contamination (2024)

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.

Class IIModerate

FDAMay 13, 2024Nationwide• Golden State Medical Supply Inc.

VICRYL Plus Antibacterial Suture (Ethicon) – Packaging Sterility (2024)

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Low

FDAMay 10, 2024Nationwide• Ethicon, Inc.

MRI Vantage Orian Systems (Canon Medical) – Cable Fastening Issue (2024)

Fire/Burn Risk

The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of the cable, ignition, smoke, and fire.

High

FDAMay 10, 2024AL, AZ, AR +35 more• Canon Medical System, USA, INC.

Medtronic Ascenda Intrathecal Catheter (Medtronic) – Design Update (2024)

Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.

Moderate

FDAMay 10, 2024Nationwide• Medtronic Neuromodulation

HistoCore Arcadia H (Leica) – Smoke and Fire Hazard (2024)

Fire/Burn Risk

An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.

High

FDAMay 10, 2024Nationwide• LEICA BIOSYSTEMS NUSSLOCH GMBH Heidelberger Str. 17-19 Nussloch Germany

MONOCRYL Plus Antibacterial Suture (Ethicon) – Packaging Sterility (2024)

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Low

FDAMay 10, 2024Nationwide• Ethicon, Inc.

PDS Plus Antibacterial Suture (Ethicon) – Packaging Sterility (2024)

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Low

FDAMay 10, 2024Nationwide• Ethicon, Inc.

PDS II Suture (Ethicon) – Packaging Sterility (2024)

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Low

FDAMay 10, 2024Nationwide• Ethicon, Inc.

VICRYL Suture (Ethicon) – Packaging Sterility (2024)

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Low

FDAMay 10, 2024Nationwide• Ethicon, Inc.

MONOCRYL Suture (Ethicon) – Packaging Sterility (2024)

Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

Low

FDAMay 10, 2024Nationwide• Ethicon, Inc.

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 10, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Duloxetine Capsules (Preferred) – Nitrosamine Contamination (2024)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAMay 10, 2024CA, CT, FL +2 more• Preferred Pharmaceuticals, Inc.

Rizatriptan Benzoate Tablets (Glenmark) – Nitrosamine Impurity (2024)

CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.

Class IIModerate

FDAMay 10, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Fixed Needle Syringes (Sol-Millennium) – 510(k) Modification (2024)

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

Low

FDAMay 9, 2024Nationwide• Sol-Millennium Medical Inc.

Exchangeable Needle Syringes (Sol-Millennium) – 510(k) Modification (2024)

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

Low

FDAMay 9, 2024Nationwide• Sol-Millennium Medical Inc.

Prowler Pro Utility Vehicles (Textron) – Potential Fire Risk (2024)

Fire/Burn Risk

This recall involves model years 2022 and 2023 Prowler Pro, Prowler Pro Crew, Tracker 800SX, and Tracker 800SX Crew utility vehicles. They were sold in various colors, including green, gray, red, fossil, and timber. "Prowler" or "Tracker" is stamped on the side of the cargo box. The 10th digit of the vehicle identification number (VIN), which is printed on the operator side of the frame under the cargo box, includes an "N" for model year 2022 and a "P" for model year 2023.

High

CPSCMay 9, 2024Nationwide• Textron Specialized Vehicles, of Augusta, Georgia

Low Dead Space Syringes (Sol-Millennium) – 510(k) Modification (2024)

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

Low

FDAMay 9, 2024Nationwide• Sol-Millennium Medical Inc.