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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)

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 321–340 of 25000 recalls

Azelaic Acid Gel (Glenmark) – Texture Complaint (2025)

CGMP Deviations: Market complaints received for gritty texture (grainy)

Class IIModerate

FDASep 17, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

RAM 4500 (RAM) – Trailer Hitch Problem (2025)

Reading Truck Body, LLC (Reading) is recalling certain 2023 Ram 4500 vehicles equipped with a Curt Hitch (P/N 15400). The trailer hitch may have been installed with too few mounting bolts, causing the assembly to loosen and detach.

Moderate

NHTSASep 17, 2025Nationwide• RAM

Phenylephrine HCI (Park Avenue) – CGMP Deviation (2025)

CGMP Deviations

Class IIModerate

1...15 161718 19...1250

Page 17 of 1250Next

FDA

Sep 17, 2025

• Park Avenue Compounding

Sentinel V11 (Spacelabs) – Patient Data Mishandling (2025)

Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm ECG functionality, under specific navigation conditions, test data intended for one patient may be saved under another patient's record

Moderate

FDASep 16, 2025Nationwide• Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom

Dried Bean Curd (G&L Food) – Undeclared Wheat (2025)

Undeclared Allergen

Undeclared allergen (wheat).

Class IIILow

FDASep 16, 2025CA• Gansu Zhaofeng Agricultural Development Co., Ltd.

Impella Controller (Abiomed) – Purge Pressure Problem (2025)

Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer failures.

Moderate

FDASep 16, 2025Nationwide• Abiomed, Inc.

Oxytocin IV Solution (IntegraDose) – No Active Ingredient (2025)

Subpotent Drug: Testing revealed there was no oxytocin in the IV bag.

Class IHigh

FDASep 16, 2025Nationwide• IntegraDose Compounding Services LLC

Catalyft Interbody System (Medtronic) – Cage Height Collapse Risk (2025)

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

Moderate

FDASep 16, 2025Nationwide• Medtronic Sofamor Danek USA Inc

FDR Visionary Suite (Fujifilm) – X-ray Support Defect (2025)

It was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not work effectively only when the shaft was broken while being operated toward the front while lifting.

Moderate

FDASep 15, 2025AK, CA, FL +5 more• FUJIFILM Healthcare Americas Corporation

Bupropion XL Tablets (Graviti) – Tablet Specification Failure (2025)

Failed Tablet/Capsule Specifications

Class IIModerate

FDASep 15, 2025Nationwide• Graviti Pharmaceuticals Private Limited

Carbamazepine Tablets (Amerisource) – Dissolution Issue (2025)

Failed Dissolution Specifications.

Class IIModerate

FDASep 15, 2025Nationwide• Amerisource Health Services LLC

Mixed Nuts Salted (Severn Peanut) – Undeclared Nut (2025)

Undeclared Allergen

Undeclared Tree Nut. The firm discovered that Hazelnuts was not listed in the allergen statement

Class IIModerate

FDASep 15, 2025MA, NY• Severn Peanut Company LLC

Mixed Nuts No Salt (Severn Peanut) – Undeclared Nut (2025)

Undeclared Allergen

Undeclared Tree Nut. The firm discovered that Hazelnuts was not listed in the allergen statement

Class IIModerate

FDASep 15, 2025MA, NY• Severn Peanut Company LLC

Galaxy System (Noah Medical) – Manual Access Problem (2025)

Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.

Low

FDASep 12, 2025CA, CO, ID +17 more• Noah Medical Corporation

Millenium MPR (GE Medical) – Service End Risk (2025)

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

Very High

FDASep 12, 2025Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel

Option ELITE Vena Cava Filter (Argon Medical) – Dilator Resistance (2025)

Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is applied

Moderate

FDASep 12, 2025Nationwide• Argon Medical Devices, Inc

Millenium MPS (GE Medical) – Service End Risk (2025)

Very High

FDASep 12, 2025Nationwide• GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 9, Andrey Sakharov Haifa Israel

Stay Informed

Glenmark Pharmaceuticals Inc., USA Recalls

Recall Summary

Azelaic Acid Gel (Glenmark) – Texture Complaint (2025)

RAM 4500 (RAM) – Trailer Hitch Problem (2025)

Phenylephrine HCI (Park Avenue) – CGMP Deviation (2025)

Sentinel V11 (Spacelabs) – Patient Data Mishandling (2025)

Dried Bean Curd (G&L Food) – Undeclared Wheat (2025)

Impella Controller (Abiomed) – Purge Pressure Problem (2025)

Oxytocin IV Solution (IntegraDose) – No Active Ingredient (2025)

Catalyft Interbody System (Medtronic) – Cage Height Collapse Risk (2025)

FDR Visionary Suite (Fujifilm) – X-ray Support Defect (2025)

Bupropion XL Tablets (Graviti) – Tablet Specification Failure (2025)

Carbamazepine Tablets (Amerisource) – Dissolution Issue (2025)

Mixed Nuts Salted (Severn Peanut) – Undeclared Nut (2025)

Mixed Nuts No Salt (Severn Peanut) – Undeclared Nut (2025)

Galaxy System (Noah Medical) – Manual Access Problem (2025)

Millenium MPR (GE Medical) – Service End Risk (2025)

Sopha Medical Vision (GE Medical) – Service End Risk (2025)

Elscint SPX6 (GE Medical) – Service End Risk (2025)

Maxicam (GE Medical) – Service End Risk (2025)

Option ELITE Vena Cava Filter (Argon Medical) – Dilator Resistance (2025)

Millenium MPS (GE Medical) – Service End Risk (2025)