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PD-Rx Pharmaceuticals, Inc.

PD-Rx Pharmaceuticals, Inc. Recalls

All product recalls associated with PD-Rx Pharmaceuticals, 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 5221–5240 of 21320 recalls

Losartan Potassium 100mg (PD-Rx Pharmaceuticals) – Impurity Levels (2022)

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Class IIModerate

FDAJun 6, 2022Nationwide• PD-Rx Pharmaceuticals, Inc.

Polypectomy Snare (Hobbs Medical) – Sheath Kinking Risk (2022)

During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.

Moderate

FDAJun 3, 2022NC, TX, WA• Hobbs Medical, Inc.

SteriSpine PS Kit (Safe Orthopaedics) – Incorrect Traceability Label (2022)

The type of screw printed on the traceability record for the patient label is incorrect, but the type of screw printed on the other labeling is correct.

Moderate

1...260 261262263 264...1066

Page 262 of 1066Next

FDA

Jun 3, 2022

• SAFE ORTHOPAEDICS LLC

Testosterone Cypionate Injection (Sun Pharma) – Machinery Abnormality (2022)

CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.

Class IIModerate

FDAJun 3, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Testosterone Cypionate Injection (Sun Pharma) – Manufacturing API Issues (2022)

CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.

Class IIModerate

FDAJun 3, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Clonazepam Orally Disintegrating Tablets (Sun Pharma) – Oversized Tablet (2022)

Failed Tablet/Capsule Specification; oversized tablet found in a bottle

Class IIModerate

FDAJun 3, 2022Nationwide• SUN PHARMACEUTICAL INDUSTRIES INC

Vivo 45LS Ventilator (Breas) – Processor Shutdown Risk (2022)

A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could potentially be Permanent impairment or life threatening if medical intervention is not obtained

High

FDAJun 2, 2022Nationwide• Breas Medical, Inc.

DVR Anatomic Plate (Changzhou Biomet) – Incorrect Plate Etching (2022)

One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates

Moderate

FDAJun 2, 2022Nationwide• CHANGZHOU BIOMET MEDICAL DEVICES CO., LTD. No. 235 Longhutangjieban Chuangxindadao Xinbei Changzhou China

YelloPort Elite Universal Seal (Surgical Innovations) – Packaging Hole Risk (2022)

There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.

Moderate

FDAJun 2, 2022Nationwide• Surgical Innovations Ltd Clayton House 6 Clayton Wood Rise Leeds United Kingdom

INFINITY Resect Guide (Wright Medical) – Incorrect Color Coding (2022)

The instrument is incorrectly color coded.

Moderate

FDAJun 2, 2022Nationwide• Wright Medical Technology, Inc.

NaturaLyte Dialysis Solution (Fresenius) – Temperature Exposure Risk (2022)

The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Leaks can lead to biological contamination and therefore an increased risk of potential bloodstream infection.

Moderate

FDAJun 1, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

epoc BGEM Test Card (Siemens) – Potential Oxygen Result Bias (2022)

Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.

Moderate

FDAJun 1, 2022AL, CA, CO +7 more• Siemens Healthcare Diagnostics Inc

HE 600 System (Ventana) – Potential Fluid Leak Fire Risk (2022)

Fire/Burn Risk

There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire

High

FDAJun 1, 2022AL, AZ, AR +37 more• Ventana Medical Systems Inc

Philips Laser System (Spectranetics) – Hardware Detection Issue (2022)

The LAS-100 Laser system may detect an inoperable hardware component during power up, which results in an error code and the system not being operable until code is cleared.

Moderate

FDAJun 1, 2022AZ, AR, CA +24 more• Spectranetics Corporation

NeuRx Diaphragm Pacing System (Synapse) – Labeling Revision (2022)

Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).

Low

FDAMay 31, 2022AL, CA, CO +16 more• Synapse Biomedical Inc

GreenLight HPSEA Laser Fibers (Boston Scientific) – Fiber Type Mismatch (2022)

Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may result in prolonged procedure while the fiber is being replaced.

Moderate

FDAMay 31, 2022AR, CA, IL +4 more• Boston Scientific Corporation

NaturaLyte Liquid Acid (Fresenius) – Alternate Cap Problem (2022)

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

Low

FDAMay 31, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

NaturaLyte Liquid Acid (Fresenius) – Alternate Cap Problem (2022)

Alternate Bottle Caps labeled with "Sealed for your Protection" on the foil not qualified for use

Low

FDAMay 31, 2022Nationwide• Fresenius Medical Care Holdings, Inc.

Variflex Suba Junior Prosthesis (Ossur) – Potential Foot Breakage (2022)

Due to receiving complaints related to broken (cracked) prosthetic foot with failures occurring in situations where sudden high impact twisting or bending is applied to the foot.

Moderate

FDAMay 30, 2022Nationwide• Ossur Americas

DBS Lead 3387S-40 (Medtronic) – Use By Date Discrepancy (2022)

There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.

Low

FDAMay 27, 2022FL, MO, TX +1 more• Medtronic Neuromodulation