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STAT806 Endpoints605 BioPharma Dive231 onclive165 Fierce Biotech74 BioSpace71 raps32 fda press20

therapy area

all Oncology81 Cardiology27 Psychiatry & CNS21 Vaccines17 Immunology17 Rare Disease12 Hepatology6 Hematology

American Regent, Inc. Issues Voluntary Nationwide Recall of One Lot of Papaverine Hydrochloride Injection, USP 60 mg/ 2 mL Due to the Presence of Visible Particulate Matter
July 24, 2026 – Shirley, NY, American Regent, Inc. is conducting a nationwide voluntary recall of a single lot of Papaverine Hydrochloride Injection, USP, 60 mg/2 mL single dose vial to the consume…
fda medwatch · 2d ago↗ source
Early Alert: Percutaneous Catheter Issue from Boston Scientific
ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use
fda medwatch · 5d ago↗ source
Sunny Pharmtech, Inc. Issues Voluntary Nationwide Recall of Cyclophosphamide for Injection, USP to the User Level Due to the Presence of Particulate Matter

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globenewswire health20

6

Infectious Disease4

July 24, 2026 - Taoyuan City, Taiwan - Sunny Pharmtech, Inc is voluntarily recalling three lots of Cyclophosphamide for Injection, USP, 1g/vial and 2g/vial, to the User Level due to the presence of…

fda medwatch · 5d ago↗ source

BAXTER ISSUES VOLUNTARY NATIONWIDE RECALL OF CEFAZOLIN IN DEXTROSE INJECTION, USP, 2G / 100ML (20MG / ML) SINGLE-DOSE INFUSION BAG IN 100ML DUE TO PARTICULATE MATTER FOUND IN SOLUTION

July 24, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling Lot LD175708, Exp 14-Feb 2027 of Cefazolin in Dextrose Injection due to a report of particulate matter…

fda medwatch · 5d ago↗ source

FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot

The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.

fda press · 6d ago↗ source

FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food

The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again.

fda press · 6d ago↗ source

Early Alert: Intravascular Administration Set Issue from Baxter

Baxter administration sets may have air bubbles in the drip chamber and tubing, which may result in air being delivered through the IV line to the patient.

fda medwatch · 9d ago↗ source

Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with Ranitidine

FOR IMMEDIATE RELEASE – July 18th, 2026 – Panoli, Gujarat, Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) is voluntarily recalling four lots of Cetirizine Hyd…

fda medwatch · 9d ago↗ source

FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol

The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduc…

fda press · 11d ago↗ source

Catheter Introducer Kit Recall: Abiomed Removes 14Fr Low Profile Introducer Kits

Prolonged use of the Abiomed 14Fr Low Profile Introducer may lead to thrombus formation.

fda medwatch · 12d ago↗ source

Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System

Affected grafts may not unclasp from the delivery system. This may require conversion to open surgical repair and can result in patient death.

fda medwatch · 12d ago↗ source

Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP

B. Braun is removing affected convenience kits containing recalled Bupivacaine Hydrochloride in Dextrose Injection components

fda medwatch · 13d ago↗ source

Convenience Kit Correction: Arrow International Issues Correction for Convenience Kits Containing Recalled Huons Lidocaine and Bupivacaine and Saline

Saline, Lidocaine and Bupivacaine from affected convenience kits should not be used.

fda medwatch · 13d ago↗ source

FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses

The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term prevention of New World screwworm (NWS) infestations (myiasi…

fda press · 13d ago↗ source

Early Alert: Ventilator Issue from Resmed

Failure of an electrical component in certain Astral ventilators may cause an interruption or failure in therapy which may result in serious injury or death

fda medwatch · 14d ago↗ source

Positive Pressure Breathing Device Correction: Baxter Issues Correction for Volera Positive Pressure Breathing Devices

Volara system patient circuits may leak air and medication from the nebulizer cup during therapy, leading to reduced oxygenation and ineffective nebulization.

fda medwatch · 15d ago↗ source

Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)

The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.

fda medwatch · 16d ago↗ source

FDA Proposes Rule to Modernize Drug Manufacturing Registration

The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a…

fda press · 18d ago↗ source

Early Alert: Convenience Kit Issue from Medical Action Industries

Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.

fda medwatch · 20d ago↗ source

Early Alert: Convenience Kits Issue from Medline

Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.

fda medwatch · 20d ago↗ source

Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump

A software anomaly may cause a false battery-health value. The pump should remain plugged in at all times.

fda medwatch · 22d ago↗ source

Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps

If dropped, the Ivenix pump touchscreen may become unresponsive and should be removed from use.

fda medwatch · 22d ago↗ source

Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit

Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.

fda medwatch · 23d ago↗ source

Heart Pump Recall: Abiomed Removes Impella CP Sets with SmartAssist

Specific Impella CP Sets are out of specification; use may result in low purge pressure events from the onset of the case

fda medwatch · 27d ago↗ source

Breathing Circuit Set Correction: Hamilton Medical Updates Use Instructions for Breathing Circuit Set

The ventilator breathing circuits are intended to connect a ventilator to a patient tube or mask. Obstruction may result in inadequate ventilation.

fda medwatch · 27d ago↗ source