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Aurobindo Pharma USA Inc

Aurobindo Pharma USA Inc Recalls

All product recalls associated with Aurobindo Pharma USA 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 1641–1660 of 25000 recalls

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

cGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class IIModerate

FDANov 7, 2024Nationwide• Aurobindo Pharma USA Inc

Bevacizumab Sterile Injection (Tailstorm Health) – Sterility Concern (2024)

Lack of Sterility Assurance

Class IIModerate

FDANov 6, 2024Nationwide• Tailstorm Health INC

OneMultivitaminic GAF-PLUS (Armonia) – Undeclared Drugs (2024)

Undeclared Allergen

Contains undeclared drugs Acetaminophen and Dexamethasone Phosphate, and the undeclared sweetener Aspartame

1...81 828384 85...1250

Page 83 of 1250Next

Class II

Moderate

FDANov 6, 2024CA, FL, GA +9 more• Armonia Natural Store LLC

GE Healthcare Optima 520 (GE Healthcare) – CT System Issue (2024)

GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can result in rotated CT images. Particularly with helical, cine, and cardiac (if applicable) scan modes, after the first image of an exam, each subsequent image can be rotated by an increasing amount. The amount of progressive image rotation is dependent on the gantry speed and the duration of the scan. The final image in the exam can be rotated up to a maximum of ~56 degrees. The entire anatomy rotates as a whole by equal degrees, without distortion, and the anatomical positioning and z-axis of the images remains correct. Small degrees of image rotation might not be noticed. If image rotation is noticed and necessitates a rescan of the patient, the same image rotation will reoccur.

Low

FDANov 5, 2024Nationwide• GE Healthcare (China) Co., Ltd. 1F-5F BLD 1, No.1 Tongji South Road, Beijing Economic-Technological Development Area Beijing China

NOA Medical Hospital Bed Rails (NOA Medical) – Side Rail Button Defect (2024)

Red button used to engage side rails can break or become stuck making it difficult to engage the side rail.

Moderate

FDANov 5, 2024CA, GA, MA +1 more• NOA Medical Industries Inc

Hydralazine HCl Tablets (Major Pharmaceuticals) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.

Class IIILow

FDANov 5, 2024Nationwide• The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Pero Family Farms Squash – Listeria Contamination (2024)

Listeria

Squash products potentially contaminated with Listeria monocytogenes.

Class IIModerate

FDANov 5, 2024FL, IL, MO +1 more• Pero Family Farms Food Company LLC

dS Breast 16ch 1.5T (Philips) – Patient Safety Risk (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Low

FDANov 4, 2024Nationwide• Philips North America Llc

dS Breast 7ch 1.5T (Philips) – Patient Safety Risk (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Low

FDANov 4, 2024Nationwide• Philips North America Llc

Mammotrak Diagnostic Coil 3.0T (Philips) – Patient Safety Risk (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Low

FDANov 4, 2024Nationwide• Philips North America Llc

dS Breast 16ch 3.0T (Philips) – Patient Safety Risk (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Low

FDANov 4, 2024Nationwide• Philips North America Llc

Achieva TX Interventional Coil (Philips) – Patient Safety Risk (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Low

FDANov 4, 2024Nationwide• Philips North America Llc

ST SENSE Breast Coil (Philips) – patient safety issue (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Low

FDANov 4, 2024Nationwide• Philips North America Llc

BYTE Aligner System (Straight Smile) – clinical workflow risk (2024)

Virtual-only clinical workflow utilized for dental aligners and impression to approve patients for aligner devices may not be suitable for patients who have certain contraindications.

Moderate

FDANov 4, 2024Nationwide• Straight Smile, LLC

dS Breast 7ch 3.0T (Philips) – Patient Safety Risk (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Low

FDANov 4, 2024Nationwide• Philips North America Llc

Continental MKC1 Brake Unit (Continental) – Brake Pedal Fastener Problem (2024)

Continental Automotive Systems, Inc. (Continental Automotive) is recalling certain MK C1 EVO brake systems with part number 10-1202. The fastener that connects the brake pedal and the brake booster may have been improperly assembled during manufacturing, which can cause the brake pedal to detach from the brake booster.

High

NHTSANov 4, 2024Nationwide• CONTINENTAL AUTOMOTIVE

ST SENSE Breast Dx Coil (Philips) – patient safety issue (2024)

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Low

FDANov 4, 2024Nationwide• Philips North America Llc

Stay Informed

Aurobindo Pharma USA Inc Recalls

Recall Summary

Cinacalcet Tablets (Aurobindo) – Impurity Limit Exceeded (2024)

Bevacizumab Sterile Injection (Tailstorm Health) – Sterility Concern (2024)

OneMultivitaminic GAF-PLUS (Armonia) – Undeclared Drugs (2024)

GE Healthcare Optima 520 (GE Healthcare) – CT System Issue (2024)

GE Healthcare Operator Console (GE Healthcare) – Console Upgrade Problem (2024)

GE Healthcare Revolution ACE (GE Healthcare) – CT System Issue (2024)

GE Healthcare Discovery RT (GE Healthcare) – CT System Issue (2024)

NOA Medical Hospital Bed Rails (NOA Medical) – Side Rail Button Defect (2024)

Hydralazine HCl Tablets (Major Pharmaceuticals) – Impurity Specifications (2024)

Pero Family Farms Squash – Listeria Contamination (2024)

dS Breast 16ch 1.5T (Philips) – Patient Safety Risk (2024)

dS Breast 7ch 1.5T (Philips) – Patient Safety Risk (2024)

Mammotrak Diagnostic Coil 3.0T (Philips) – Patient Safety Risk (2024)

dS Breast 16ch 3.0T (Philips) – Patient Safety Risk (2024)

Achieva TX Interventional Coil (Philips) – Patient Safety Risk (2024)

ST SENSE Breast Coil (Philips) – patient safety issue (2024)

BYTE Aligner System (Straight Smile) – clinical workflow risk (2024)

dS Breast 7ch 3.0T (Philips) – Patient Safety Risk (2024)

Continental MKC1 Brake Unit (Continental) – Brake Pedal Fastener Problem (2024)

ST SENSE Breast Dx Coil (Philips) – patient safety issue (2024)