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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

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 421–440 of 4747 recalls

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

Class IHigh

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – Dissolution Failed (2024)

Failed Dissolution Specifications

Class IHigh

FDAMay 30, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

Potassium Chloride Capsules (Glenmark) – CGMP Deviations (2024)

CGMP Deviations

Class IIModerate

1...20 212223 24...238

Page 22 of 238Next

FDA

May 30, 2024

Nationwide

• Glenmark Pharmaceuticals Inc., USA

Gas Relief Drops (Denison) – cGMP Deviations (2024)

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

Class IIModerate

FDAMay 28, 2024Nationwide• Denison Pharmaceuticals, LLC

Docetaxel Injection (Sagent) – Particulate Matter (2024)

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Class IHigh

FDAMay 28, 2024Nationwide• Sagent Pharmaceuticals

Docetaxel Injection (Sagent) – Particulate Matter (2024)

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Class IHigh

FDAMay 28, 2024Nationwide• Sagent Pharmaceuticals

PROBEAT-FR (Hitachi) – Image Matching Software Error (2024)

During positioning within the system's 3D to 3D matching mode while transferring CBCT images, when the Float Image Selection button is pressed, it may display CBCT images that are insufficient in number.

FDAMay 27, 2024Nationwide• Hitachi America, Ltd., Particle Therapy Division

VITROS Chemistry Diluent Pack (Ortho-Clinical) – Sample Result Bias (2024)

VITROS Chemistry Products FS Diluent Pack 3, Lot 01-1645 may cause results to be negatively biased when used to dilute patient samples tested with VITROS Chemistry Products CRP Slides.

FDAMay 21, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

RAPIDPoint 500e Blood Gas System (Siemens) – Sample Source Identification (2024)

Siemens Healthineers has identified an issue with the RAPIDPoint500e system software version 5.3. This issue affects how the sample source is identified at the LIS when using the capillary mode. With this software version, samples run in the capillary mode are incorrectly labeled as arterial when displayed on the LIS, leading to the potential for results to be flagged according to an established arterial range. Capillary sample results are correctly identified as capillary on both the RAPIDPoint 500e system display and the instrument printouts. The issue only affects the new software version 5.3 and only capillary sample mode is impacted. The inability to distinguish specimen sources for blood gas may lead to incorrect diagnoses and management decisions.

FDAMay 17, 2024Nationwide• Siemens Healthcare Diagnostics Inc

Duloxetine Capsules (Breckenridge) – Impurity Concern (2024)

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

Class IIModerate

FDAMay 17, 2024Nationwide• Breckenridge Pharmaceutical, Inc

BIOFIRE FILMARRAY GI Panel (BioFire) – False Positive Results (2024)

Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium.

FDAMay 16, 2024Nationwide• BioFire Diagnostics, LLC

Estradiol Patch (Zydus) – Specification Failure (2024)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMay 16, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

Estradiol Patch (Zydus) – Specification Failure (2024)

Failed Impurities/Degradation Specifications.

Class IIILow

FDAMay 16, 2024Nationwide• Zydus Pharmaceuticals (USA) Inc

EYLEA Injection (Regeneron) – Syringe Breakage Risk (2024)

Lack of Assurance of Sterility: Complaints of syringe breakage

Class IIModerate

FDAMay 15, 2024Nationwide• Regeneron Pharmaceuticals Inc

VITROS Chemistry Calibrator Kit (Ortho-Clinical) – Expiration Date Error (2024)

Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its true expiration and the customer does not have their Assay Data Disk (ADD) updated, the system will allow them to use the expired calibrator which may bias the results. However, at this time the calibrator is within its use date and will function appropriately.

FDAMay 14, 2024Nationwide• Ortho-Clinical Diagnostics, Inc.

Sight OLO CBC Test Kit (Sight Diagnostics) – Platelet Count Bias (2024)

One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.

FDAMay 13, 2024Nationwide• SIGHT DIAGNOSTICS LTD 23, Derekh Menakhem Begin Tel Aviv-Yafo Israel

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

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 13, 2024Nationwide• Glenmark Pharmaceuticals Inc., USA

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.