Hi-Tech Pharmaceuticals Inc. Recalls

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Phytoform Fruits & Greens (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDAAug 6, 2025AL, AZ, AR +46 more• Hi-Tech Pharmaceuticals Inc.

Phytoform Fruits & Greens (Hi-Tech Pharmaceuticals) – Unapproved Claims (2025)

Unapproved Drug Claims and Misbranded.

FDA

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Aug 6, 2025

AL, AZ, AR +46 more

• Hi-Tech Pharmaceuticals Inc.

Enoxaparin Sodium Injection (Cardinal Health) - Product Mispack (2025)

Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL

FDAAug 5, 2025KS• Cardinal Health Inc.

Sensodyne PRONAMEL (Haleon) - Labeling Mix-up (2025)

Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton

FDAAug 5, 2025Nationwide• Haleon US Holdings LLC

Raman Spectrometers (Wasatch Photonics) – laser safety (2025)

Two new potential laser safety failure modes have been identified in the product design. Overcurrent of laser diode, and a fail-unsafe mode. The failure modes have never been found to occur in these models, whether in the field or factory, but could potentially occur under excessive force or extreme, continuous vibration.

FDAAug 4, 2025Nationwide• WASATCH PHOTONICS

Novum IQ Large Volume Pump (Baxter) – device correction (2025)

Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).

FDAAug 4, 2025PR• Baxter Healthcare Corporation

Novum IQ Syringe Pump (Baxter) – device correction (2025)

FDAAug 4, 2025PR• Baxter Healthcare Corporation

Azurion System (Philips) – power supply issue (2025)

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

FDAAug 1, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura Xper X-Ray System (Philips) – component missing (2025)

Potential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series.

Low

FDAAug 1, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura System (Philips) – power supply issue (2025)

Philips Azurion and Allura systems configured with a 1 Phase Uninterruptible Power Supply (UPS) have the potential of shutting down and/or not starting up, if power to the system is lost.

FDAAug 1, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

RECOMBINATE Antihemophilic Factor (Cardinal Health) – Temperature Deviation (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Xolair Omalizumab Injection (Cardinal Health) – Temperature Deviation (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Xolair Injection (Cardinal Health) - Temperature Exposure (2025)

CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.

FDAJul 30, 2025Nationwide• Cardinal Health Inc.

Sucralfate Tablets (Amerisource) – Quality Monitoring Failure (2025)

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.

FDAJul 29, 2025Nationwide• Amerisource Health Services LLC

PrisMax V2 Hemodialysis System (Vantive) – priming problem (2025)

Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles

FDAJul 28, 2025Nationwide• VANTIVE US HEALTHCARE LLC

PrisMax V3 Control Unit (Vantive) – blood leak detection (2025)

Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Normalization Failed, or T1205: BLD Self-Test Failure

FDAJul 28, 2025Nationwide• VANTIVE US HEALTHCARE LLC

TherMax Blood Warmer (Vantive) – therapy setup issue (2025)

Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted