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 Proline 100mg/mL vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Pharmakon Pharmaceuticals is recalling 10 units of Hydromorphone HCI cadd cassettes because the company cannot guarantee the products are sterile.
Medaus, Inc. is recalling Pyridoxine HCL 100mg/mL vials because the company cannot assure the sterility of the product.
Pharmakon Pharmaceuticals is recalling 105 bags of compounded Fentanyl Citrate and Bupivacaine due to a lack of assurance of sterility.
Medaus, Inc. is recalling M.I.C 25/50/50 vials because the company cannot guarantee the product is sterile.
Pharmakon Pharmaceuticals is recalling 20 units of Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassettes due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 2,580 units of compounded Propofol 1% injection because the company cannot ensure the product is sterile.
Medaus, Inc. is recalling Lidocaine 2% (PF) in NaCl 10mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling specific lots of Hydrogen Peroxide 3% vials because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 129 bags of Ropivacaine HCI 0.2% due to a lack of assurance of sterility. The product was distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 2,000 units of compounded Midazolam HCI syringes due to a lack of assurance of sterility.
Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 100 units of compounded Fentanyl and Bupivacaine syringes due to a lack of assurance of sterility.
Medaus, Inc. is recalling M.I.C. 25/50/50 (PF) vials because the company cannot ensure the product is sterile. The recall covers multiple lots distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling Lipo-Boost vials because the company cannot guarantee the product's sterility. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Pharmakon Pharmaceuticals is recalling Potassium Chloride IV bags because they may not be sterile. The recall covers products distributed nationwide and to specific VA/DOD facilities.
Dr. Praeger's Sensible Foods is voluntarily recalling frozen California Veggie Burgers because they may be contaminated with Listeria monocytogenes.
Pharmakon Pharmaceuticals is recalling 45 bags of compounded Midazolam HCI due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling Phenylephrine HCI syringes because the company cannot ensure the products are sterile.
Medaus, Inc. is recalling specific lots of Methyl B12 5mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
Pharmakon Pharmaceuticals is recalling 225 syringes of Methohexital (Brevital Sodium) 10 mg/mL because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 90 units of Hydromorphone HCI syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Hardy Diagnostics is recalling 25 QuickSlide MGS-80 and GramPRO-80 automated Gram stainers because they may produce discrepant culture and Gram stain results, potentially leading to misdiagnosis or improper patient treatment.
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.