Early Alert: Medline ReNewal Reprocessed EP Catheters with Residual Particulates – What You Need to Know
Date of FDA Page Update: August 6, 2025 U.S. Food and Drug Administration The device and product details These catheters are used for electrophysiology (EP) mapping, stimulation, and recording in diagnosing and managing cardiac arrhythmias via endocardial and intravascular access. U.S. Food and Drug Administration Reason for the Early Alert Medline ReNewal found that affected […]
Max Mobility / Permobil Expands Worldwide Recall of SmartDrive SpeedControl Dial — Investigative report and manufacturer action plan
Published: August 12, 2025Source: Company announcement posted on FDA recalls page. U.S. Food and Drug Administration Executive summary (quick take) Max Mobility / Permobil has announced a voluntary, worldwide expanded recall and market removal of all SpeedControl Dials used with the SmartDrive MX2+ power-assist device. The action covers every SpeedControl Dial manufactured and distributed between […]
FDA & CDC Recommend Pause of IXCHIQ (Chikungunya Vaccine, Live) for Adults 60+ — An Investigative Update
Published: May 12, 2025 (FDA safety communication).Quick summary: The FDA and CDC have recommended a temporary pause in the use of IXCHIQ® (Chikungunya Vaccine, Live) for people 60 years and older while agencies investigate postmarketing reports of serious neurologic and cardiac events, including deaths. This article explains what’s known, what the agencies are doing, who’s […]
FDA Requires New Class Warning for mRNA COVID-19 Vaccines: Myocarditis/Pericarditis Update (June 2025)
Meta title (≤60 chars): FDA adds myocarditis warning to mRNA COVID-19 shotsMeta description (≤155 chars): FDA now requires updated warnings on Pfizer and Moderna mRNA COVID-19 vaccines, with new incidence estimates and post-marketing findings. TL;DR What exactly did FDA do? The new label language—what’s different? Why the update now? FDA determined new safety information met […]
FDA lifts pause on IXCHIQ for adults ≥60 and approves new label warnings
What happened—quick timeline Why the concern in the first place? IXCHIQ is a live, attenuated chikungunya vaccine; it can produce chikungunya-like symptoms. FDA’s case review included serious adverse events in older adults, some consistent with severe complications of chikungunya disease (e.g., encephalitis). One death from encephalitis was specifically noted in FDA’s safety communication, and earlier […]
FDA Alerts: Severe Itching Risk After Stopping Long-Term Use of Cetirizine or Levocetirizine
What’s the Issue? On May 16, 2025, the FDA issued a Drug Safety Communication warning that discontinuation of cetirizine (Zyrtec) or levocetirizine (Xyzal)—after long-term, daily use—can cause rare but severe and widespread itching (pruritus), sometimes requiring medical attention. This risk applies to both prescription and over-the-counter (OTC) forms. U.S. Food and Drug AdministrationPeople.com How Often […]
Breaking: Amneal Issues Nationwide Recall of Sulfamethoxazole/Trimethoprim Tablets Due to Microbial Contamination
What’s Being Recalled? On June 2, 2025, Amneal Pharmaceutical LLC initiated a nationwide recall of three specific lots of Sulfamethoxazole/Trimethoprim Tablets, USP, 400 mg/80 mg, due to microbial contamination. Tablets from the affected lots may display black spots, identified as Aspergillus, a potentially harmful fungus. This recall only applies to two pack sizes—100-count and 500-count […]
FDA Adds Heat-Risk Warning to Transderm Scōp (Scopolamine Patch): What Patients, Clinicians, and Manufacturers Need to Know
What happened (and when)? On June 18, 2025, the U.S. FDA issued a Drug Safety Communication requiring new warnings for the anti-nausea patch Transderm Scōp. The agency concluded the patch can increase body temperature and lead to heat-related complications, with reports that include hospitalizations and, in some cases, death. Most reported cases occurred in children […]
FDA Mandates New Warnings on Extended-Release ADHD Stimulants
What’s Changing? On June 30, 2025, the U.S. Food and Drug Administration (FDA) issued a safety communication requiring all manufacturers of extended-release (ER) stimulants—including both amphetamine and methylphenidate formulations—used for attention-deficit/hyperactivity disorder (ADHD) to revise their prescribing information (PI). The update mandates inclusion of a “Limitation of Use” section highlighting that children under 6 years […]