FDA, CMS and EU regulatory updates
Announcements, safety alerts, recalls and reimbursement news from the US Food and Drug Administration, the Centers for Medicare and Medicaid Services and the European Medicines Agency — collected automatically and filterable by date.
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- FDASo Delicious Dairy Free® Issues Voluntary Recall of Salted Caramel Cluster Non-Dairy Frozen Dessert Pints Due to Potential Presence of Foreign Material
WHITE PLAINS, N.Y. and LOUISVILLE, Colo., September 15, 2026 – Danone USA is issuing a voluntary recall of So Delicious Dairy Free® Salted Caramel Cluster Non-Dairy Frozen Dessert pints with best-by dates on and before April 3, 2028 due to the potential presence of foreign materials, such as small
- CMSTrump Administration Announces $104 Million to Transform Rural Healthcare Across Mississippi Through Cutting-Edge Technology and Expanded Care Closer to Home
<p class="text-align-center"><span><strong>Trump Administration Announces $104 Million to Transform Rural Healthcare Across Mississippi Through Cutting-Edge Technology and Expanded Care Closer to Home </strong></span></p><p class="text-align-center"><em><span>This federal investment will support 167 awards to expand specialty and diagnostic care, improve healthcare facilities and equipment, and bring more services closer to home</span></em></p>
- CMSCMS Cracks Down on Massive $3.4 Billion Medical Equipment Supplier Fraud Scheme
<p class="text-align-center"><span><strong>CMS Cracks Down on Massive $3.4 Billion Medical Equipment Supplier Fraud Scheme</strong></span></p><p class="text-align-center"><em><span><strong>Companies Billed Medicare for Deceased Beneficiaries</strong></span></em></p>
- CMSCMS Adds Medicare Options to Help People Manage Substance Use Disorder, Heart Failure, and Other Common Chronic Conditions
<p class="text-align-center"><strong>CMS Adds Medicare Options to Help People Manage Substance Use Disorder, Heart Failure, and Other Common Chronic Conditions </strong><br><em>ACCESS Model Now Available to People with Original Medicare</em></p><p>Starting in Spring 2027, the Centers for Medicare & Medicaid Services (CMS) will expand an existing initiative to offer technology-supported care options to Medicare beneficiaries who have heart failure, chronic obstructive pulmonary disease (COPD), substance use disorders, and nicotine dependence. With these additions, CMS will enable more
- FDAFDA Launches Expedited IND Pilot, Begins Accepting Applications
The U.S. Food and Drug Administration today announced the final design of the Expedited Investigational New Drug (IND) Pilot.
- FDAEsophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device
The Medtronic and Given Imaging Bravo CF esophageal pH monitoring capsule can fail to attach to the esophagus or detach from its delivery device.
- FDAA&P Creations LLC Issues Nationwide Recall of biQ-FEL Due to Undeclared Sildenafil and Tadalafil
Sildenafil and Tadalafil are active ingredients in FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approval of Viagra and Cialis is restricted to use under the supervision of a licensed health care professional. These undeclared ingredients ma
- FDAA&P Creations LLC Issues Nationwide Recall of X10 Natural Enhancement Supplement Due to Undeclared Sildenafil and Tadalafil
Clermont, Florida – A&P Creations LLC is recalling X10 Natural Enhancement Supplement to the consumer level because it has been found to contain undeclared sildenafil and tadalafil.
- CMSCMS, SBA, and Georgia Recognize Innovative CHOICE Arrangements as Major Win for Small Businesses
<p class="text-align-center"><span><strong>CMS, SBA, and Georgia Recognize Innovative CHOICE Arrangements as Major Win for Small Businesses</strong></span></p><p class="text-align-center"><em><span>Trump Administration Initiative Expands Resources for Health Insurance Affordability, Choice, and Coverage Options for Small Businesses and Workers</span></em></p>
- CMSTrump Administration Expands Preventive and Behavioral Healthcare Access for Students Across Rural North Carolina
<p class="text-align-center"><span><strong>Trump Administration Expands Preventive and Behavioral Healthcare Access for Students Across Rural North Carolina </strong></span></p><p class="text-align-center"><em><span>This federal investment will strengthen school-based healthcare through new locations, telehealth and mobile care for children in rural communities</span></em></p>
- CMSTrump Administration Announces Nearly $17 Million to Adopt Emerging Healthcare Technologies and Improve Patient Transportation Between Facilities Across Rural Kansas
<p class="text-align-center"><span><strong>Trump Administration Announces Nearly $17 Million to Adopt Emerging Healthcare Technologies and Improve Patient Transportation Between Facilities Across Rural Kansas</strong></span></p><p class="text-align-center"><em><span>This federal investment will help rural providers adopt cutting-edge technology and improve transportation to specialty and behavioral healthcare</span></em></p><p><span>The Trump Administration announced today that a nearly $17 million investment is being delivered to support rural healthcare technology and increase patient transp
- FDAWhole Foods Market Issues Allergy Alert on Undeclared Egg in Cabricharme Cheese
Whole Foods Market of Austin, TX is recalling Fromagerie Coop de Mean Cabricharme cheese because the product contains egg lysozyme, an egg white protein, which is not declared on the product label. People who have an allergy or severe sensitivity to eggs run the risk of a serious or life-threateni
- FDACentric Compounding Issues Nationwide Recall of Glutathione, Myer’s Cocktail, and Tri-Immune Boost Due to Elevated Endotoxin Levels
FOR IMMEDIATE RELEASE – 9/9/2026 – Houston, Texas, Centric Compounding is voluntarily recalling 6 lots of Glutathione 200mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable vials to the consumer level. The products have been found to be compounded with a Glutathione API containing elevated endot
- EUMeeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 September 2026
CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion for a marketing authorisation for Cirbloc, for the active immunisation of pigs from…
- FDAEvergreen Fresh Sprouts LLC Recalls Broccoli Sprouts Because of Possible Health Risk
09/10/2026, Evergreen Fresh Sprouts LLC of Moyie Springs, IDAHO is recalling 215 cases (6/4oz bags per case) of Broccoli Sprouts, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly pe
- CMSTrump Administration Announces $4.8 Million to Strengthen West Virginia’s Rural Healthcare Workforce and Expand Preventive Care
<p class="text-align-center"><span><strong>Trump Administration Announces $4.8 Million to Strengthen West Virginia’s Rural Healthcare Workforce and Expand Preventive Care </strong></span></p><p class="text-align-center"><em><span>This federal investment will support the rural healthcare workforce and expand preventive care while new funding opportunities will increase access to home dialysis and medical transportation </span></em></p>
- CMSTrump Administration Announces $11.7 Million to Expand Access, Improve Patient Care Facilities, and Strengthen Workforce Capacity in Nursing Homes and Long-Term Care System Across Rural Vermont
<p class="text-align-center"><span><strong>Trump Administration Announces $11.7 Million to Expand Access, Improve Patient Care Facilities, and Strengthen Workforce Capacity in Nursing Homes and Long-Term Care System Across Rural Vermont</strong></span></p><p class="text-align-center"><em><span>This federal investment will increase the number of healthcare professionals and reinforce long-term care serving rural Vermonters </span></em></p>
- FDAEpidural Kit Correction: Medical Action Industries Issues Correction for Epidural Kits Containing Spectra Medical Devices Lidocaine Ampules
Medical Action Industries is correcting epidural kits containing recalled Huons Co. sodium chloride ampules.
- FDAFreshPoint Issues Recall Due to an Improperly Declared Allergen (Egg) in Chicken Salad Wedge Sandwiches
September 4, 2026 Orlando, FL– FreshPoint of Orlando, FL., is issuing a voluntary recall of 1,093 units of specific lots of Cranberry Chicken Salad Wedge sandwiches due to an improperly declared allergen (eggs). People who have an allergy or severe sensitivity to eggs run the risk of serious or lif
- FDABMC Medical Co., Ltd. Recalls Luna G3 APAP (Model LG3600) with Firmware G3-2.00.76 Due to Firmware Defect
On July 15, 2026, BMC Medical Co., Ltd. (BMC), Beijing, China, retrospectively reported to the US Food and Drug Administration (FDA) a recall of 20,160 Luna G3 APAP (Model LG3600) devices distributed in the United States due to firmware defect. This corrective action was not reported to customers. O
- FDAMade Fresh Salads, Inc. Recalls Ready to Eat Deli Style Salads and Cream Cheese Because of Possible Health Risk
Made Fresh Salads Inc. of Bay Shore, NY is recalling all Ready to Eat Deli Style Salads and cream cheese, because they have the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and
- FDAFDA Takes Steps to Maintain Newborn Access to Life-Saving Starter Nutrition Products
The U.S. Food and Drug Administration today announced it is taking action, consistent with the Trump administration’s commitment to protecting vulnerable patients and maintaining access to critical medical products, to help address a potential supply gap of neonatal starter parenteral nutrition (PN)
- FDAFDA Grants Accelerated Approval to a New Breast Cancer Treatment
The U.S. Food and Drug Administration today expanded treatment options for adult patients with advanced breast cancer, reflecting the FDA’s commitment to advancing medical innovation and getting new treatments to patients who need them.
- FDAFoods Alive Recalls Organic Moringa Leaf Powder Because of Possible Health Risk
Foods Alive Inc of Angola, IN, is recalling its 8-ounce packages of organic moringa leaf powder because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened
- CMSTrump Administration Invests $25 Million to Modernize Healthcare Technology, Expand Telehealth, and Improve High-Speed Internet Connectivity Across Michigan
<p class="text-align-center"><span><strong>Trump Administration Invests $25 Million to Modernize Healthcare Technology, Expand Telehealth, and Improve High-Speed Internet Connectivity Across Michigan</strong></span></p><p class="text-align-center"><em><span>This federal investment will help expand access and upgrade technology so doctors and patients can better connect and coordinate care across Michigan</span></em></p>
- CMSTrump Administration Announces $5.48 Million to Strengthen Healthcare Workforce Pipeline in Rural Rhode Island
<p class="text-align-center"><span><strong>Trump Administration Announces $5.48 Million to Strengthen Healthcare Workforce Pipeline in Rural Rhode Island</strong></span></p><p class="text-align-center"><em><span>This federal investment will expand career and technical education in Rhode Island to help train the next generation of healthcare professionals</span></em></p>
- EUMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026
Review will assess risk of low blood phosphate levels and related bone problems with injectable iron medicinesEMA’s safety committee, PRAC, has started a review of injectable…, Agenda Agenda of the PRAC meeting 31 August - 3 September 2026Draft Reference Number: EMA/PRAC/164465/2026 Corr.1…, PRAC statistics: September 2026 Monthly figures for PRAC outcomes based on the draft agenda. @ European Medicines Agency, PRAC statistics:…, Ongoing referrals Procedure: Parenteral iron-containing medicinal products - referral, Glossary Safety signal assessments. A safety signal is information which sugges
- EUNew EU supply chain to end Visudyne shortage
A new supply chain for Visudyne (verteporfin) has been put in place in the European Union (EU), marking an important step towards resolving a long-standing shortage of the…, This situation shows the complexity of shortages and how coordination between the European Commission, EU Member States, MSSG and SPOC Working Party can ensure fair…, Medicine shortages can have serious consequences for patients and public health and place a heavy burden on healthcare systems. The limited availability of Visudyne has impacted…
- FDAAmerican Regent, Inc. Issues Voluntary Nationwide Recall of Three Lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) Due to the Presence of Particulate Matter and Lack of Assurance of Sterility
FOR IMMEDIATE RELEASE – September 3, 2026 – New Albany, OH, American Regent, Inc. is conducting a nationwide voluntary recall of three lots of Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vials to the consumer level. Customer complaints were received for leaking and cracked vials, re
- FDAFDA Approves First Drug to Treat Alexander Disease
The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in pediatric and adult patients.
- FDAB. Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container Due to the Presence of Particulate Matter
FOR IMMEDIATE RELEASE – September 3, 2026– Bethlehem, PA, B. Braun Medical Inc (B. Braun) is voluntarily recalling three (3) lots of 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container, to the hospital/healthcare facility/user level due to presence of particulate matter identified
- FDAFi Recalls Supplements for Dogs Because of Possible Salmonella Contamination
Fi, of New York, NY, is recalling the supplements for dogs listed below because they have the potential to be contaminated with Salmonella due to an ingredient supplied to Fi’s manufacturer. The manufacturer has suspended production while it investigates. Fi is promptly notifying all affected custom
- FDAFDA Issues Emergency Use Authorization for Drugs to Prevent and Treat New World Screwworm in Dogs and Cats
The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Capstar (nitenpyram) tablets and revised the EUA for Nitenpyram Tablets, the generic version of Capstar
- FDASUPPLX.com Issues Voluntary Nationwide Recall of Business Pill and Branch Manager for Men Due to Undeclared Yohimbine
Grant-Valkaria, Florida - SUPPLX.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels.
- FDAFDA Seeks Public Input to Advance Development of Botanical Drug Products
The U.S. Food and Drug Administration today announced a request for information (RFI) to gather public input on opportunities to advance the development of botanical drug products.
- FDASpinal Cord Stimulator Recall: Boston Scientific Removes Infinion CX Lead
Infinion CX Lead bodies may experience mechanical stress at the anchor site resulting in inadequate stimulation requiring lead explant and replacement.
- FDAEarly Alert: Heart Pump Controller Purge Cassette Issue from Abiomed
Abiomed is removing Automated Impella Controllers due to purge cassette recognition failures that may lead to prolonged delayed in mechanical circulatory support.
- FDAMonitoring System Correction: GE HealthCare Updates Use Instructions for Portrait Core Services Software
Patients monitored on Portrait Mobile devices may be discharged (removed) from the Portrait monitoring system during an update to the Portrait Core Services software.
- FDAEarly Alert: Breathing Circuit Issue from Draeger
Removal of VentStar Resus Neo hoses due to the potential for cracks resulting in restricted ventilation or delayed therapy.
- FDAFrutas y Hortalizas Del Sur S.A. Expands Recall to Include One Lot of Great Value Frozen Organic Triple Berry Blend Because of Potential Contamination with Escherichia Coli 0145 (E. Coli O145)
[PRESSWIRE] San Carlos, Chile – 2 September 2026 — Frutas y Hortalizas del Sur S.A. expands its July 3, 2026, recall of frozen organic IQF blueberries to include one lot of Great Value frozen Organic Triple Berry Blend 10 OZ because of potential contamination with Escherichia coli O145 (E. coli O145
- FDAEarly Alert: Convenience Kit Issue from AVID Medical
AVID Medical is correcting convenience kits containing recalled Huons Co. sodium chloride ampules.
- FDACatheter Recall Expansion: Medline Industries Removes Reprocessed Electrophysiology and Ultrasound Catheters
Certain reprocessed catheters may contain residual particulates that could cause infection, embolism, or thrombosis
- FDAConvenience Kit Correction: Medline Issues Correction for Convenience Kits Containing BD ChloraPrep Applicators
Certain BD ChloraPrep Applicators in Convenience Kits manufactured by Medline may not be sterile.
- EUVoluntary data submission pilot to advance innovative alternatives to animal testing
EMA has launched a new voluntary data submission (VDS) pilot to facilitate the sharing of data generated using New Approach Methodologies (NAMs). These innovative methods have…
- FDABreathing Circuit Recall: Medline Removes Neonatal and Infant Heated Wire Breathing Circuits
Medline is recalling certain neonatal and infant heated wire breathing circuits due to failures involving the electrical connector.
- FDACrystal Temptations Issues Allergy Alert on Undeclared Milk in Chocolatey Eyeballs
Crystal Temptations of North Arlington, NJ is recalling Halloween Chocolatey Eyeballs because they contain undeclared MILK allergens. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.
- FDALMSI LLC/Kofinas Olive Oil Issues a Voluntary Recall of its Garlic Mediterranean Infused Extra Virgin Olive Oil for Using a Garlic Essential Oil Not Approved for Culinary Use
Cincinnati, OH (Aug. 29, 2026) - LMSI LLC/ Kofinas Olive Oil is issuing a voluntary recall of its Garlic Mediterranean infused extra virgin olive oil for using a garlic essential oil not approved for culinary use. The flavored oil was bottled in glass bottles in 500 ml, 250 ml, and 100 ml sizes.
- FDAAna Salazar Modela Tu Cuerpo Inc. Issues Nationwide Voluntary Recall of Lipofit Extreme Fat Burner 2.0 Due to Presence of Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP)
FOR IMMEDIATE RELEASE - August 27, 2026 - Davie, Florida – Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level. The Food and Drug Administration (FDA) laboratory analysis has found Lipofit Extreme Fat Burner 2.0 to
- FDANorthwest Naturals Voluntarily Recalls Two Raw Pet Food Products Because of Possible Salmonella & Listeria Monocytogenes Health Risk
Northwest Naturals of Portland, Oregon is voluntarily recalling 53 cases (1,272 lbs.) of Northwest Naturals Frozen Chicken Recipe (cat food 2 lbs. bag) and 19 cases (684 lbs.) of Northwest Naturals Frozen Raw Diet for Dogs Chicken Recipe (6 lbs. bag) in the two lots identified due to Salmonella and
- FDAFDA Approves First Drug of Its Kind for Polycythemia Vera, a Rare Blood Disorder
The U.S. Food and Drug Administration today approved Mimrylo (rusfertide), a new treatment for adults with polycythemia vera, a rare blood disorder that causes the body to make too many red blood cells.
- FDAEverything Sprouts, LLC Expands Voluntarily Recall to Include Robust Radish Mix Due to Potential E. Coli and Salmonella Risk
Everything Sprouts, LLC, based in Minneapolis, MN is expanding its voluntary recall of sprouts to include certain lots of Robust Radish Sprout Mix because it has the potential to be contaminated with Shiga toxin producing Escherichia coli (STEC) or Salmonella bacteria.
- FDAPanorama Produce Recalls Mangoes Due to Possible Salmonella Contamination
MAMARONECK, NY, AUG. 28, 2026 - Panorama Produce is recalling 302 boxes of size 9 (nine) mangoes because they may be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. H
- FDAEarly Alert: IV Start Kit Issue from Avid Medical
Avid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides. <br> <br>
- FDAEarly Alert: Angiographic Catheter Issue from Boston Scientific
Boston Scientific Imager II Angiographic Catheters removed due to a manufacturing issue leading to tip detachment; could result in procedural delays, embolism
- FDAFDA Approves First Oral Drug Indicated to Treat Dermatomyositis in Adults
The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets for the treatment of dermatomyositis in adults.
- FDAFDA Issues Emergency Use Authorization for Generic Drug to Prevent New World Screwworm in Cattle
FDA issues Emergency Use Authorization (EUA) for Bimectin (ivermectin) injection for the prevention of New World screwworm (NWS) infestations (myiasis) in cattle when administered within 24 hours of birth, at the time of castration, or at the appearance of a wound.
- FDAConvenience Kit Correction: AVID Medical Issues Correction for Kits Containing Medline Namic Star Off Handle Manifolds
AVID Medical is correcting convenience kits containing Manifolds affected by the Medline Namic Angiographic Star Off Handle Manifold Recall.
- FDAFDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer
The U.S. Food and Drug Administration today approved Rasonque (daraxonrasib), a RAS inhibitor for the most common form of pancreatic cancer—delivering a new treatment option to patients with advanced pancreatic cancer months ahead of schedule.
- FDABaxter Issues Voluntary Nationwide Recall for Two Lots of 0.9% Sodium Chloride Injection Due to Potential Presence of Particulate Matter
FOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling two lots of 0.9% Sodium Chloride Injection due to the potential presence of particulate matter identified as fiberglass in the solution.
- FDAPercutaneous Catheter Recall: Boston Scientific Removes ENROUTE Transcarotid Neuroprotection System
ENROUTE Transcarotid Neuroprotection Systems may have arterial sheath tip separation or partial tip separation during use. <br> <br>
- FDAFDA Authorizes First Wearable Device That Continuously Monitors Both Ketone Levels and Blood Sugar
The U.S. Food and Drug Administration today authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for people aged 2 years and older living with diabetes.
- FDABaxter Issues Voluntary Nationwide Recall for One Lot of Anticoagulant Sodium Citrate Solution Due to Potential Presence of Particulate Matter
FOR IMMEDIATE RELEASE – AUG. 25, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling one lot of Anticoagulant Sodium Citrate Solution due to the potential presence of particulate matter identified as fiberglass in the solution.
- FDAFDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia
The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) as the first-ever treatment for adults and children 8 years of age and older with glycogen storage disease type Ia (GSDIa)
- FDAFDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device
The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention.
- FDAFDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices
The U.S. Food and Drug Administration today issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics
Updates are collected automatically from the agencies' own public feeds and link back to the original announcement. CAHIR does not alter agency wording.