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  • US charges two Indian nationals in counterfeit Ozempic distribution scheme
    The U.S. Attorney’s Office for the Middle District of Florida and the DOJ’s Criminal Division announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals, for…
    fda press · 1mo agoRegulatoryNegative↗ source
  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 1mo agoApprovalPositive↗ source
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Pain775
Nephrology759
  • FDA to review and potentially overhaul PMTA rules amid lawsuit and illicit market concerns
    FDA announced it is reviewing its experience with the Premarket Tobacco Product Application (PMTA) rule and recent court actions. The agency cites the growth of an illicit market and rapid introdu…
    fda press · 1mo agoRegulatoryNeutral↗ source
  • Sierra Nevada Cheese Company recalls all Graziers raw milk cheeses over possible E. coli O26:H11 contamination
    Sierra Nevada Cheese Company of Willows, California, announced a voluntary recall of its Graziers Raw Milk Cheese line, which includes Monterey Jack, Jalapeno Jack, Medium Cheddar and Sharp Cheddar…
    fda recalls · 1mo agoNegative↗ source
  • Mezzetta voluntarily recalls 32-oz Golden Greek Peperoncini after pest contaminant found in jar
    G. L. Mezzetta Inc. announced a voluntary recall of its 32‑oz Golden Greek Peperoncini after a video showed a pest contaminant in a jar. The recall is limited to lot 720106 (SKU 10106328). The com…
    fda recalls · 1mo agoRegulatoryNeutral↗ source
  • Boston Scientific recalls Imager II angiographic catheters over tip detachment risk
    Boston Scientific has issued a recall of its Imager II Angiographic Catheters after a manufacturing problem that can cause the catheter tip to detach during use. The FDA classified the recall as t…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Abiomed issues recall of Automated Impella Controllers over purge cassette detection issue
    Abiomed has announced a recall of its Automated Impella Controllers after identifying failures in the purge cassette recognition system, which could lead to prolonged delays in mechanical circulato…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Galil Importing Corp recalls Lior ground cinnamon over elevated lead levels
    Galil Importing Corp of Hauppauge, New York announced a recall of its Lior Cinnamon Ground Seasoning because of potential elevated lead contamination. The product, distributed to retail outlets in…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Deano’s Pasta recalls 20 lbs of ravioli over undeclared lobster allergen
    Deano’s Pasta of Somerville, Massachusetts announced a recall of its Pear and Pecorino Triangoli Ravioli after discovering the product may contain undeclared lobster, a crustacean shellfish allerge…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Convenience Kit Correction: Becton Dickinson Issues Correction for Kits and Procedure Trays Containing Recalled Sodium Chloride Ampules
    BD is correcting convenience kits and procedural trays containing recalled Huons Co. sodium chloride ampules
    fda medwatch · 1mo ago↗ source
  • FDA issues early alert on React Health VOCSN ventilators over connector fault
    The FDA's Center for Devices and Radiological Health has posted an early alert about a potential high‑risk problem with certain VOCSN ventilator units made by Ventec Life Systems, operating as Reac…
    fda medwatch · 1mo agoRegulatoryNeutral↗ source
  • FDA issues early alert on Abiomed Impella controller safety issue
    The FDA Center for Devices and Radiological Health (CDRH) has posted an Early Alert about a potential high risk problem with certain Abiomed Impella automated controllers. Abiomed has sent a lette…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Federal Court Issues Consent Decree Halting Gold Star Distribution's FDA-Regulated Shipments Over Unsanitary Warehouse
    The U.S. District Court for the District of Minnesota entered a consent decree on Sept. 21, 2026 that permanently enjoins Gold Star Distribution, Inc. and its owner Bassam Abu Samrah from distribut…
    fda press · 1mo agoRegulatoryNegative↗ source
  • Berlin Seeds recalls 950 lbs of alfalfa sprouting seed over possible STEC and Salmonella contamination
    Berlin Seeds of Millersburg, Ohio announced a recall of 950 pounds of its alfalfa sprouting seed. The recall was triggered because the seed could be contaminated with Shiga toxin‑producing Escheri…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • FDA issues rule to allow non-animal testing methods for drug safety
    FDA issued a direct final rule that updates its regulations to clarify that non-animal methods may be used for safety testing of drugs and biological products before they are tested in humans. The…
    fda press · 1mo agoRegulatoryPositive↗ source
  • Global Mix Inc. recalls Niwali Tejocote supplements after FDA finds toxic yellow oleander content
    Global Mix Inc., based in Middle Village, New York, announced a recall of its Niwali Tejocote Capsules and Pieces, both marketed as herbal dietary supplements. The FDA’s analysis indicated the pro…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Par Health recalls two lots of dexmedetomidine infusion due to particulate contamination
    Par Health announced a voluntary recall of two lots of its dexmedetomidine HCl in 0.9% sodium chloride injection, which is used for intravenous sedation. The recall was initiated after testing ide…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Otsuka ICU Medical recalls one lot of 0.9% Sodium Chloride injection after possible potassium chloride mix-up
    Otsuka ICU Medical LLC announced a voluntary recall of a single lot of its 0.9% Sodium Chloride Injection, USP, 100 mL. The recall was triggered after a customer complaint revealed that the overwr…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • CooperSurgical issues recall of INCA infant nasal CPAP sets over loose connection risk
    CooperSurgical has announced a recall of its INCA infant nasal CPAP complete and replacement sets. The recall is due to a potential loose connection between the flexible tubing and the nasal cannu…
    fda medwatch · 1mo agoCRLNegative↗ source
  • AVID Medical issues correction for convenience kits containing recalled Huons sodium chloride ampules
    AVID Medical has released a correction notice for certain convenience kits that include sodium chloride ampules from Huons Co., which are subject to a recall. The FDA has classified this recall as…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Spectra Medical recalls Sodium Chloride Flush ampules due to serious safety risk
    Spectra Medical Devices has issued a recall of its Sodium Chloride Injection 0.9% USP 10 mL flush ampules that were manufactured by Huons Co., Ltd. The FDA classified the recall as the most serious…
    fda medwatch · 1mo agoCRLNegative↗ source
  • FDA updates instructions for NOxBOXi nitric oxide delivery system after leak risk identified
    The FDA has issued a correction for the NOxBOXi nitric oxide delivery system with the NOxMixer module after discovering that the device can leak oxygen during inhaled nitric oxide therapy. The age…
    fda medwatch · 1mo agoCRLNeutral↗ source
  • GF Blends recalls AIP flour and flatbread mixes over undeclared wheat gluten
    GF Blends announced a recall of its Truly AIP All Purpose Flour and Bread Mix and the EAT G.A.N.G.S.T.E.R. Flat Bread Pizza Mix because testing found undeclared wheat gluten. The products were mad…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known…
    fda press · 1mo agoApprovalPositive↗ source
  • Saratoga Potato Chips recalls J. HIGGS Loaded Bacon & Cheddar chips over undeclared soy allergen
    Saratoga Potato Chips of Fort Wayne, Indiana announced a recall of two best‑if‑used‑by codes of its 7.75‑ounce J. HIGGS Loaded Bacon and Cheddar potato chips because the product may contain undecla…
    fda recalls · 1mo agoCRLNeutral↗ source