Severity 4 of 5
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Severity 4 (Severe) recalls have a real, documented risk of significant injury, hospitalization, or property damage even if no deaths have been reported. The agency classification is FDA Class II with hospitalization reports, USDA Class I, or a structural vehicle defect. These need attention quickly — not five-alarm urgency but not something to put off. Examples include allergen mislabeling on common allergens for products eaten by children, drug potency out of specification by a margin that could cause measurable harm, and vehicle defects affecting braking or steering.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Oregon Compounding Centers is recalling Epinephrine 1:1000 injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling specific lots of Methycobalamin injectable due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Ceftazidime syringes because quality control issues observed during an FDA inspection may compromise sterility assurance.
Oregon Compounding Centers is recalling Bevacizumab/Dexamethasone injectable syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Papaverine HCL injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Mitomycin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling 40 syringes of Ganciclovir due to quality control issues affecting sterility assurance found during an FDA inspection.
Oregon Compounding Centers is recalling Copper Sulfate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Hydroxocobalamin (B12) injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Trience 8mg/2.0mL injectable syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling specific lots of injectable Papaverine HCL/Phentolamine/Prostaglandin due to quality control issues affecting sterility assurance.
High Quality Organics is recalling 780 lbs of Organic Ginger Tea Bag Cut after a sample tested positive for Salmonella.
AMS Health Sciences is recalling Saba Shark Cartilage Complex dietary supplements due to the potential presence of Salmonella.
Oregon Compounding Centers is recalling 145 vials of Chorionic Gonadotropin due to quality control issues affecting sterility assurance.
Oregon Compounding Centers is recalling Dexamethasone injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Papaverine/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance.
Oregon Compounding Centers is recalling Lidoaine HCL solution for irrigation due to quality control issues affecting sterility assurance.
Oregon Compounding Centers is recalling Papaverine HCL/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance.
Whole Foods Vegan Gingersnap Cookies are being recalled because they contain undeclared walnut, almond, milk, soy, and egg.
Oregon Compounding Centers is recalling Alprostadil injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Pyridoxine HCL injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Mitomycin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Baxter Healthcare is recalling 20,448 units of INTRA VIA containers due to particulate matter found inside the fluid path.
Oregon Compounding Centers is recalling Vancomycin injectable syringes due to quality control issues affecting sterility assurance identified during an FDA inspection.
Iba Dosimetry Gmbh is recalling COMPASS software version 3.1 because a defect may prevent detection of dose distribution errors, potentially leading to incorrect radiation doses during treatment.