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.
Medaus, Inc. is recalling specific lots of HCL 2MG/ML (PF) 5ML Vials because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 10 bags of Diltiazem HCI 250 mg in 5% Dextrose due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 40 vials of compounded Midazolam (PF) 5mg/ml 25 mL BD syringes due to a lack of assurance of sterility.
Medaus, Inc. is recalling B-Complex Without B12 vials because the FDA could not ensure the product was sterile. The recall covers 5 mL and 10 mL vials distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling L-Carnitine 50mg/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 Lipo-Injection 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.
Dr. Praeger's Sensible Foods is voluntarily recalling frozen California Veggie Balls because they may be contaminated with Listeria monocytogenes.
Dr. Praeger's Sensible Foods is voluntarily recalling Aldi Kale Burgers because they may be contaminated with Listeria monocytogenes.
Pharmakon Pharmaceuticals is recalling 216 units of Vancomycin HCL 1.25 GM in 5% Dextrose bags due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 280 vials of compounded Epinephrine injection due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 70 bags of Norepinephrine Bitartrate 8mg in 5% Dextrose due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 2,175 units of Succinylcholine Chloride 20 mg/mL syringes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 468 units of compounded Oxytocin 30 Units in Lactated Ringers due to a lack of assurance of sterility.
Medaus, Inc. is recalling Testosterone Cypionate vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling specific lots of Riboflavin 10mg/mL vials because the company cannot ensure the product is sterile.
Medaus, Inc. is recalling specific vials of Testosterone Cypionate 25 mg/mL due to a lack of assurance of sterility. The affected product was distributed in the U.S., Japan, and New Zealand.
Pharmakon Pharmaceuticals is recalling 20 bags of compounded Fentanyl Citrate and Ropivacaine HCI due to a lack of assurance of sterility.
Medaus, Inc. is recalling specific lots of Lipo B Cyano 1mg/mL vials because the company cannot ensure the product is sterile.
Dr. Praeger's is voluntarily recalling frozen California Veggie Burgers because they may be contaminated with Listeria monocytogenes.
Medaus, Inc. is recalling specific lots of Cesium Chloride 600mg/mL vials because the company cannot assure the sterility of the product.
Dr. Praeger's Sensible Foods is voluntarily recalling frozen Black Bean Burgers because they may be contaminated with Listeria monocytogenes.
Hospira is recalling 38,878 LifeCare PCA infusion systems because wear on a component may prevent the pump from detecting distal occlusions, a defect that has resulted in one serious injury.
Dr. Praeger's Sensible Foods is voluntarily recalling specific lots of frozen Black Bean Sliders because they may be contaminated with Listeria monocytogenes.
Pharmakon Pharmaceuticals is recalling Fentanyl Citrate 50 mcg/ml injections due to a lack of assurance of sterility. The recall affects 4,050 syringes distributed nationwide and to specific VA/DOD facilities.
Medaus, Inc. is recalling specific lots of Folic Acid 10mg/mL vials due to a lack of assurance of sterility. The affected products were distributed in the U.S., Japan, and New Zealand.