Tag: fda

Eugia US Recalls Nationwide Lot of Vancomycin Injection Vials Over Glass Particle

9 Nov 2026 4:19 p.m.

The voluntary recall of lot 3VM26026A of Vancomycin Hydrochloride for Injection USP 1.25 g/30 mL single-dose vials reaches hospitals, healthcare facilities and users nationwide, though no adverse events have been reported.

Health Business Law Enforcement Medical Science Legal Social Issues Product Recall Eugia US LLC Vancomycin Hydrochloride for Injection US Food and Drug Administration glass particle contamination pulmonary embolism East Windsor, New Jersey Food Recalls FDA Drugs Eugia US Glass Particulate Contamination MedWatch Auro Medics Pharma
Fresh & Ready Foods Recalls 2,414 Sausage, Egg & Cheese Biscuit Sandwiches Over Listeria Risk

9 Nov 2026 4:19 p.m. · Source: US Food and Drug Administration

Fresh & Ready Foods LLC is recalling 2,414 Fresh To You Sausage, Egg & Cheese Biscuit Sandwiches sold in Oregon and Washington over possible Listeria monocytogenes contamination linked to a biscuit supplier recall.

Health Business Law Enforcement Medical Science Social Issues Fresh & Ready Foods LLC Product Recall Listeria monocytogenes Fresh To You Sausage, Egg & Cheese Biscuit Sandwich CH Guenther & Son Renton, Washington US Food and Drug Administration Food Recalls FDA Drugs
FDA Requires New Label Warnings on GLP-1 Drugs Over Rare Eye Condition Risk

9 Nov 2026 1:17 p.m. · Source: US Food and Drug Administration

The FDA is requiring makers of GLP-1 receptor agonist medications to add warnings about a potential increased risk of NAION, a rare eye condition that can cause permanent vision loss.

Health Politics and Government Federal Government Medical Science Law Enforcement US Food and Drug Administration GLP-1 receptor agonists NAION Drug safety labeling Vision loss MedWatch Type 2 diabetes Food Recalls FDA Drugs
FDA Investigating Serious Risk of Malignancy Linked to Zolgensma Gene Therapy

6 Nov 2026 9:02 p.m. · Source: US Food and Drug Administration

FDA says postmarketing reports link Zolgensma to malignancies, including confirmed insertional oncogenesis involving the GLI1 gene, and warns the risk applies to Itvisma as well.

Health Science & Technology Politics and Government Medical Science Federal Government Legal Zolgensma Itvisma Food and Drug Administration insertional oncogenesis spinal muscular atrophy gene therapy Novartis Food Recalls FDA Drugs
Once Upon A Farm Recalls All Tractor Wheels Toddler Bars Over Choking Hazard

4 Nov 2026 8:00 a.m.

The recall covers every lot and variety sold nationwide including Puerto Rico, after three FDA choking complaints; no injuries have been reported.

Health Business Law Enforcement Medical Science Social Issues Product Recall Once Upon a Farm Tractor Wheels Organic Toddler Soft-Baked Bars US Food and Drug Administration Choking Hazard Toddler Food MedWatch Food Recalls FDA Drugs Tractor Wheels toddler snacks Puerto Rico Once Upon a Farm Tractor Wheels Costco Walmart
Brad's Raw Chips Recalls Crunchy Kale and Veggie Chips Over Potential Thallium Contamination

3 Nov 2026 4:22 p.m. · Source: US Food and Drug Administration

Snack Right Super Foods, doing business as Brad's Raw Chips, is recalling about 25,000 bags of Crunchy Kale and Veggie Chips sold nationwide because they may contain thallium.

Health Business Law Enforcement Medical Science Social Issues Product Recall Brad's Raw Chips Snack Right Super Foods thallium kale chips US Food and Drug Administration KeHE Distributors Food Recalls FDA Drugs
FDA Issues Early Alert as Compact Medical Recalls ButterflyBVM Resuscitators Over Bellows Hole Risk

3 Nov 2026 3:22 p.m. · Source: US Food and Drug Administration

Compact Medical has recalled certain lots of ButterflyBVM single-use resuscitators and updated use instructions after holes in the bellows were linked to a risk of inadequate ventilation and hypoxia.

Health Business Law Enforcement Medical Science Legal Product Recall Compact Medical ButterflyBVM Bag-Valve-Mask Resuscitator US Food and Drug Administration Medical Device Recall Hypoxia Food Recalls FDA Drugs
FDA Flags Most Serious Class of Recall for HemosIL AcuStar HIT-IgG (PF4-H) Test Kits

31 Oct 2026 9:30 a.m. · Source: US Food and Drug Administration

Instrumentation Laboratories (Werfen) has pulled four lots of its HemosIL AcuStar HIT-IgG (PF4-H) assay after confirming a negative bias that could mask heparin-induced thrombocytopenia.

Health Science & Technology Law Enforcement Medical Science Legal Business Product Recall HemosIL AcuStar HIT-IgG (PF4-H)Instrumentation Laboratories Werfen US Food and Drug Administration heparin-induced thrombocytopenia medical device Food Recalls FDA Drugs
Vitality Works Recalls 365 Whole Foods Market Ashwagandha Capsules Over Salmonella Risk

30 Oct 2026 3:52 p.m. · Source: US Food and Drug Administration

Vitality Works Inc. is recalling one lot of 365 Whole Foods Market Ashwagandha Capsules sold nationwide on Amazon and at Whole Foods Market stores over potential Salmonella contamination. No illnesses reported.

Health Business Law Enforcement Medical Science Social Issues Product Recall Vitality Works Inc.Salmonella Ashwagandha Capsules Whole Foods Market US Food and Drug Administration Albuquerque, New Mexico Food Recalls FDA Drugs
SLR Food Distribution Recalls Wise Wife Brand Ground Cinnamon Over Elevated Lead Levels

30 Oct 2026 3:49 p.m. · Source: US Food and Drug Administration

SLR Food Distribution Inc. of Hicksville, New York, is voluntarily recalling Wise Wife Brand Ground Cinnamon sold in 14 states after the product was found to have potentially elevated lead levels.

Health Business Law Enforcement Medical Science Legal Product Recall SLR Food Distribution Inc.Wise Wife Brand Ground Cinnamon Lead Contamination US Food and Drug Administration Hicksville, New York Food Safety Food Recalls FDA Drugs
FDA: Stop Using Affected Nova StatStrip Gen 2.0 Glucose Meters Until Software Update

30 Oct 2026 3:16 p.m. · Source: US Food and Drug Administration

FDA updates its Nova Biomedical StatStrip Glucose Hospital Meter notice, urging customers to follow new instructions and switch to an alternative meter if available until a software update arrives.

Health Science & Technology Law Enforcement Medical Science Legal Product Recall US Food and Drug Administration Nova Biomedical StatStrip Glucose Hospital Meter System Medical Devices Software Update Hospital Glucose Meter Food Recalls FDA Drugs
Medline Exits Bed Market Over Fire and Entrapment Risks After Two Deaths

29 Oct 2026 5:01 p.m.

The FDA issued an Early Alert covering all Medline Brand beds, pendants, accessories, replacement parts and bed-containing order packages, with two deaths and 16 serious injuries reported as of October 20, 2026.

Health Business Law Enforcement Medical Science Social Issues Legal Medline FDA Medical Device Recall Hospital Beds Fire Hazard Entrapment Product Recall Food Recalls Drugs Entrapment Risk
Haifa Smoked Fish Recalls Cold Smoked Sprats Over Botulism Risk

28 Oct 2026 4:38 p.m. · Source: US Food and Drug Administration

Haifa Smoked Fish of Queens, New York is recalling about 560 lbs of Cold Smoked Sprats sold in New York, New Jersey and Pennsylvania over potential Clostridium botulinum contamination. No illnesses reported.

Health Business Law Enforcement Medical Science Social Issues Product Recall Haifa Smoked Fish Cold Smoked Sprats Clostridium botulinum Botulism US Food and Drug Administration Food Safety Food Recalls FDA Drugs
Taylor Farms Recalls H-E-B Backyard BBQ Chop Salad Kit Over Undeclared Soy and Almonds

28 Oct 2026 4:38 p.m. · Source: US Food and Drug Administration

Taylor Farms of Dallas, Texas is recalling H-E-B Backyard BBQ Chop Salad kits because they may contain undeclared soy and tree nuts (almonds), posing a risk to people with allergies.

Health Business Law Enforcement Agriculture Product Recall Taylor Farms H-E-B Backyard BBQ Chop Salad kit undeclared soy tree nuts almonds US Food and Drug Administration Food Recalls FDA Drugs
FDA Issues Early Alert as B. Braun Removes Streamline Bloodline Set for Dialog+

27 Oct 2026 2:35 p.m. · Source: US Food and Drug Administration

B. Braun has pulled three lots of its Streamline Bloodline Set for Dialog+ after a missed solvent step left dialyzer connectors weakly bonded, risking detachment, leaks and blood loss.

Health Business Law Enforcement Medical Science Legal Product Recall B. Braun Streamline Bloodline Set for Dialog+US Food and Drug Administration Hemodialysis Bloodlines Medical Device Recalls and Early Alerts Food Recalls FDA Drugs
Tonight We Ride Recalls Ultimate Forza Male Supplement Over Undeclared Viagra, Cialis and SSRI Ingredients

26 Oct 2026 4:44 p.m.

All lots of the capsules, sold at some independently owned GNC franchises from 2017 to October 1, 2026, contain undeclared sildenafil, tadalafil and dapoxetine, the FDA said.

Health Business Law Enforcement Medical Science Legal Social Issues Product Recall Ultimate Forza Tonight We Ride LLC US Food and Drug Administration sildenafil tadalafil dapoxetine Food Recalls FDA Drugs Ultimate Forza Male Supplement Tonight We Ride
Natural Grocers Recalls Organic Mung Beans Over Glass Fragments

23 Oct 2026 4:08 p.m. · Source: US Food and Drug Administration

Vitamin Cottage Natural Food Markets recalls Natural Grocers Brand Organic 2-Pound Mung Beans after customer complaints of sharp glass fragments; lots shipped to 22 states from June 10, 2026.

Health Business Law Enforcement Social Issues Product Recall Natural Grocers mung beans Vitamin Cottage Natural Food Markets US Food and Drug Administration glass fragments Lakewood, Colorado Food Recalls FDA Drugs
WinCo Foods Recalls Hoagie Rolls Over Undeclared Sesame

23 Oct 2026 4:08 p.m. · Source: US Food and Drug Administration

WinCo Foods is recalling 16oz Hoagie Rolls sold in seven western states after manufacturer United States Bakery found sesame flour was missing from the ingredient list and allergen statement.

Health Business Law Enforcement Medical Science Social Issues Product Recall WinCo Foods sesame allergy United States Bakery hoagie rolls US Food and Drug Administration food allergen labelling Food Recalls FDA Drugs
Wedgewood Pharmacy Recalls Compounded Veterinary Medications Over Potency Concerns

23 Oct 2026 4:05 p.m. · Source: US Food and Drug Administration

Wedgewood Pharmacy is recalling compounded veterinary medications shipped nationwide between February and October 2026, citing unreliable lab testing data that may have produced subpotent or superpotent products.

Health Business Law Enforcement Medical Science Legal Product Recall Wedgewood Pharmacy LLC US Food and Drug Administration compounded veterinary medications potency animal health Swedesboro, New Jersey Food Recalls FDA Drugs
FDA Early Alert Issued After Cardinal Health Updates Instructions for Presource Packs With BD Alaris Infusion Sets

20 Oct 2026 2:41 p.m.

BD testing found previously claimed infusion performance was overestimated, with deviations most common at rates under 1 mL/h and bolus volumes of 5 mL or less.

Health Business Law Enforcement Medical Science Legal Federal Government Product Recall FDA Cardinal Health BD Alaris Pump Infusion Sets Presource Packs Medical Devices Early Alert Food Recalls Drugs BD Alaris Pump Infusion Set US Food and Drug Administration Medical Device Recalls and Early Alerts Program Infusion pumps
FDA Alerts to Nova Biomedical StatStrip Gen 2.0 Glucose Meter Removal Over Patient ID Mix-Up Risk

20 Oct 2026 10:55 a.m. · Source: US Food and Drug Administration

Nova Biomedical has told customers to remove StatStrip Gen 2.0 hospital glucose meters until a software update is available, after barcode scanning errors risked assigning results to the wrong patient.

Health Science & Technology Law Enforcement Medical Science Computers and Internet Legal Product Recall Nova Biomedical StatStrip Glucose Hospital Meter US Food and Drug Administration Medical Devices Patient Safety Glucose Monitoring Food Recalls FDA Drugs
Lidl US Recalls Gelatelli Coffee & Vanilla Gelato Over Listeria Risk

19 Oct 2026 4:29 p.m. · Source: US Food and Drug Administration

Lidl US is recalling one lot of Gelatelli Coffee & Vanilla Gelato sold in ten states and Washington, DC, over possible Listeria monocytogenes contamination. No illnesses have been reported.

Health Business Law Enforcement Medical Science Social Issues Product Recall Lidl US Gelatelli Coffee & Vanilla Gelato Listeria monocytogenes US Food and Drug Administration Food Safety Food Recalls FDA Drugs
Krasnyi Oktyabr Inc. Recalls Starfish Seafood Cold Smoked Norwegian Salmon Over Listeria Risk

19 Oct 2026 4:24 p.m. · Source: US Food and Drug Administration

Brooklyn-based Krasnyi Oktyabr Inc. is voluntarily recalling 227g/8oz packages of Starfish Seafood Premium Cold Smoked Norwegian Salmon Sliced over possible Listeria monocytogenes contamination. No illnesses reported.

Health Business Law Enforcement Medical Science Social Issues Product Recall Krasnyi Oktyabr Inc.Starfish Seafood Listeria monocytogenes Cold Smoked Norwegian Salmon US Food and Drug Administration Food Safety Food Recalls FDA Drugs
Family Farmstead Dairy Recalls Raw Mild Cheddar Cheese Over E. coli Risk

19 Oct 2026 4:22 p.m. · Source: US Food and Drug Administration

Family Farmstead Dairy of Worcester, NY is recalling a lot of raw mild cheddar cheese over potential E. coli O26:H11 and O45:H2 contamination, with product sent to seven states and possibly beyond.

Health Business Law Enforcement Medical Science Agriculture Social Issues Product Recall Family Farmstead Dairy Raw Mild Cheddar Cheese E. coli O26:H11 E. coli O45:H2 US Food and Drug Administration Worcester, New York Food Recalls FDA Drugs
UK Regulator MHRA Takes AI and MedTech Agenda to AdvaMed 2026

19 Oct 2026 11:07 a.m. · Source: UK Government

MHRA's Jessica Paulsen will outline a lifecycle-based approach to AI-enabled medical devices at AdvaMed 2026, backed by the AI Airlock sandbox, new regional partnerships and closer FDA collaboration.

Health Science & Technology Politics and Government Business Artificial Intelligence Medical Science Regulatory Trade Europe United Kingdom MHRA AdvaMed 2026 AI in healthcare medical devices FDA AI Airlock Jessica Paulsen UK Government
Family Farmstead Dairy Recalls Raw Mild Cheddar Cheese Over E. coli O157:H7 Risk

16 Oct 2026 4:29 p.m. · Source: US Food and Drug Administration

Family Farmstead Dairy of Worcester, NY recalls a lot of raw mild cheddar cheese sold to grocers in New York and New Jersey over potential E. coli O157:H7 contamination.

Health Business Law Enforcement USA General Politics Federal Government Agriculture Product Recall Family Farmstead Dairy Raw Mild Cheddar Cheese E. coli O157:H7 Hemolytic Uremic Syndrome US Food and Drug Administration Worcester, NY Food Recalls FDA Drugs
FDA Early Alert: Edwards Lifesciences Recalls SAPIEN M3 Delivery Systems After Balloon Bursts, One Death

16 Oct 2026 9:36 a.m. · Source: US Food and Drug Administration

FDA warns of Edwards Lifesciences Commander M delivery system recall over bursting balloons during SAPIEN M3 mitral valve replacement, with one death and one serious injury reported as of October 5.

Health Business USA Medical Science Law Enforcement Product Recall Edwards Lifesciences SAPIEN M3 Commander M delivery system FDA Transcatheter Mitral Valve Replacement Medical Device Recall Food Recalls Drugs
Pan Pepín Recalls Para Bien Al Grano in Puerto Rico Over Undeclared Sesame

14 Oct 2026 4:52 p.m.

The voluntary recall covers certain lots distributed throughout Puerto Rico, and no illnesses or reactions have been reported.

Health Business Law Enforcement Puerto Rico USA Medical Science Social Issues Product Recall Pan Pepín Inc.Para Bien Al Grano Sesame allergen US Food and Drug Administration Bayamón Food Recalls FDA Drugs Pan Pepin Inc.sesame allergy
Par Health Recalls Two Lots of Brevital Sodium Over Cellulose Particulate Matter

14 Oct 2026 4:46 p.m.

The nationwide recall of Brevital Sodium 500 mg/vial, distributed to wholesalers between July 2025 and May 2026, carries a risk of life-threatening adverse health consequences including pulmonary emboli.

Health Business Law Enforcement Medical Science Legal USA Social Issues Product Recall Par Health Brevital Sodium Methohexital Sodium for Injection US Food and Drug Administration Particulate Matter Rochester, Michigan Food Recalls FDA Drugs Methohexital Sodium MedWatch
Par Health Recalls 22 Lots of Argatroban Injection Nationwide Over Particulate Matter

14 Oct 2026 4:56 p.m.

The voluntary recall to the hospital/user level covers lots distributed nationwide between December 30, 2024, and May 5, 2026, after cellulose, polystyrene, polyethylene terephthalate, stopper material and possibly stainless steel were detected in certain lots.

Health Business Law Enforcement Medical Science Legal Social Issues Par Health Argatroban Injection Product Recall US Food and Drug Administration Particulate Matter Rochester, Michigan Pulmonary Emboli Food Recalls FDA Drugs Heparin-Induced Thrombocytopenia MedWatch