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.
Pharmakon Pharmaceuticals is recalling 384 units of compounded Oxytocin 30 Units in 0.9% Sodium Chloride due to a lack of assurance of sterility.
Medaus, Inc. is recalling specific vials of Pyridoxal/Thiamine/Lidocaine due to a lack of assurance of sterility. The affected products were distributed in the U.S., Japan, and New Zealand.
Pharmakon Pharmaceuticals is recalling 95 bags of compounded Fentanyl and Ropivacaine due to a lack of assurance of sterility.
Medaus, Inc. is recalling L-Carnitine 500mg/mL vials because the company cannot assure the product's sterility. The recall covers products distributed in the U.S., Japan, and New Zealand.
Dr. Praeger's Sensible Foods is voluntarily recalling frozen California Veggie Burger Sliders because they may be contaminated with Listeria monocytogenes.
Medaus, Inc. is recalling Dexpantenol 250mg/mL vials because the company cannot ensure the product is sterile.
Medaus, Inc. is recalling Molybdenum 250mcg/mL vials because the company cannot ensure the product is sterile. The recall covers distribution in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling Testosterone Cypionate vials because the company cannot guarantee the product is sterile.
Pharmakon Pharmaceuticals is recalling 20 units of compounded Hydromorphone HCI syringes due to a lack of assurance of sterility.
Medaus, Inc. is recalling M.I.C./B-Complex (PF) vials because the company cannot assure the sterility of the product. The recall affects 3,000 mL in vials distributed in the U.S., Japan, and New Zealand.
Pharmakon Pharmaceuticals is recalling 175 units of compounded Ketamine 20 mg/mL due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 100 vials of Hydromorphone HCI 0.2mg/ml PCA solution due to a lack of assurance of sterility.
Medaus, Inc. is recalling Lipo with Lidocaine #3 vials because the company cannot ensure the product is sterile. The recall covers 5 mL and 10 mL vials distributed in the U.S., Japan, and New Zealand.
Pharmakon Pharmaceuticals is recalling 560 vials of Hydromorphone HCl 0.4mg/mL in 30 mL syringes due to a lack of assurance of sterility.
Medaus, Inc. is recalling specific lots of Arginine 100mg/mL vials because the company cannot assure the product is sterile.
Pharmakon Pharmaceuticals is recalling Cefazolin 2GM in 5% Dextrose 50 mL due to a lack of assurance of sterility. The recall affects 1,450 units distributed nationwide.
Pharmakon Pharmaceuticals is recalling Epinephrine HCI syringes because the company cannot ensure the products are sterile.
Pharmakon Pharmaceuticals is recalling 400 units of Atropine Sulfate syringes because the company cannot ensure the products are sterile.
Pharmakon Pharmaceuticals is recalling 800 syringes of Ephedrine Sulfate 5 mg/ml due to a lack of assurance of sterility.
Medaus, Inc. is recalling specific lots of B-Complex 50 vials because the company cannot ensure the product is sterile.
Medaus, Inc. is recalling specific lots of Hydroxy B12 1000mcg/mL vials because the company cannot ensure the product is sterile.
The Kroger Co is recalling Roasted & Salted Sunflower Kernels because the supplier notified them of a potential Listeria monocytogenes contamination.
Dr. Praeger's is voluntarily recalling Aldi California/Black Bean Veggie Burgers because they may be contaminated with Listeria monocytogenes.
Medaus, Inc. is recalling specific lots of Zinc Sulfate 1mg/mL vials because the company cannot ensure the product is sterile.
Medaus, Inc. is recalling specific vials of Methyl B12 injection due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.