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.
Eldorado is recalling 2016 Aerotech, Aero Elite, and Advantage shuttle buses because a component in the electrical power distribution center may break, causing electrical arcing and increasing the risk of fire.
GNP Company is recalling approximately 55,608 pounds of chicken products that may be contaminated with sand and black soil. No illnesses have been reported.
Red Bowl Foods is recalling wonton and dumpling products because they contain egg, a known allergen, that is not declared on the label.
Eldorado is recalling 2012-2016 Amerivan 10 vehicles because an improperly installed fuel line may leak and cause a fire.
Well Care Compounding Pharmacy is recalling 869 vials of SUPER TRI-MIX #4 because FDA inspections found violations that may affect sterility.
Well Care Compounding Pharmacy is recalling QUAD-MIX #3 vials because FDA inspections found violations that may affect product sterility.
Novacare, LLC is recalling Thin and Slim Burn Fat Now dietary supplements because FDA sampling confirmed the presence of salicylic acid, an unapproved drug ingredient.
Well Care Compounding Pharmacy is recalling 1-HCG 1000 IU/ML vials because FDA inspections identified GMP violations that may impact product sterility.
Baxter Healthcare is recalling Dextrose Injection, USP, 70% due to confirmed reports of an insect found in the primary container.
Novacare, LLC is recalling MaxOut Body Fat Burner with Ephedra because FDA sampling confirmed the presence of salicylic acid in the dietary supplement.
Well Care Compounding Pharmacy is recalling QUAD-MIX #1 vials because FDA inspections found violations that may affect sterility.
Mercedes-Benz is recalling 5,826 model year 2016 GLE450 vehicles because a software error may cause the engine to shut down while braking, increasing crash risk.
Well Care Compounding Pharmacy is recalling Estradiol Valerate 40mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Estradiol Valerate 20mg/mL vials due to GMP violations affecting sterility.
Well Care Compounding Pharmacy is recalling Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Gentamicin 15 mg/ml Ophthalmic Solution due to FDA inspection findings regarding sterility assurance.
Well Care Compounding Pharmacy is recalling specific lots of Clotrimazole 1%/Betamethasone Dipropionate 0.05% Otic Solution because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Methylcobalamin 1 mg/mL vials because FDA inspections found GMP violations that may impact product sterility.
Novacare, LLC is recalling Thin and Slim Naturally AM dietary supplements because FDA sampling confirmed the presence of unapproved salicylic acid.
Novacare, LLC is recalling TruTrim dietary supplements marketed without FDA approval because they contain salicylic acid.
Well Care Compounding Pharmacy is recalling 869 vials of a compounded injectable vitamin mixture due to FDA inspection findings that raised concerns about product sterility.
Well Care Compounding Pharmacy is recalling TRI-MIX # 3 vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling levocarnitine 100mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Thor Motor Coach is recalling 2014-2016 Tuscany motor homes because the brake signal to towed devices may not deactivate, causing dragging brakes and fire risk.
GE Healthcare is recalling 97 MSK 1.5T Extreme MR Scanners because gas venting may not occur properly, posing a risk of oxygen deprivation.