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 DMSO 99.9 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 384 units of compounded Oxytocin in Lactated Ringers due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 1,925 vials of Rocuronium 10 mg/mL syringes because the company cannot guarantee the product is sterile.
Hospira Inc. is recalling 373,850 tubes of Diazepam Injection USP 10mg/2mL because the product contains particulate identified as crystallized active ingredient.
Dr. Praeger's is voluntarily recalling Jumbo California Veggie Burgers because they may be contaminated with Listeria monocytogenes.
Medaus, Inc. is recalling Testosterone Cypionate vials because the company cannot guarantee the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Pharmakon Pharmaceuticals is recalling 670 vials of compounded Hydromorphone HCl 0.4mg/ml due to a lack of assurance of sterility. The products were distributed nationwide to VA and DOD facilities.
Dr. Praeger's Sensible Foods is voluntarily recalling specific frozen veggie burgers 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. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling Hyaluronidase 500U/ML vials because the company cannot assure the sterility of the product. The recall affects lots distributed in the U.S., Japan, and New Zealand.
Pharmakon Pharmaceuticals is recalling 485 units of compounded Promethazine 25 mg in 0.9% Sodium Chloride bags due to a lack of assurance of sterility.
Medaus, Inc. is recalling Nandrolone Decanoate 200mg/mL vials because the company cannot guarantee the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling specific lots of Sodium Ascorbate 500mg/mL 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 EDTA Disodium 15% 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 800 syringes of Phenylephrine HCI 100mcg/mL due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling Cefazolin 2GM in 100 mL 0.9% Sodium Chloride bags because the company cannot guarantee the products are sterile.
Medaus, Inc. is recalling Methyl B12 10mg/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 260 syringes of compounded fentanyl and bupivacaine due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 870 bags of compounded Fentanyl and Bupivacaine due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 40 units of compounded Promethazine injection due to a lack of assurance of sterility. The product was distributed nationwide to VA and DOD facilities.
Pharmakon Pharmaceuticals is recalling 600 vials of compounded Ketamine 100mg/mL due to a lack of assurance of sterility. The product was distributed nationwide to VA and DOD facilities.
Medaus, Inc. is recalling specific lots of Calcium Sodium EDTA 300mg/mL vials because the agency cannot assure the product's sterility.
Pharmakon Pharmaceuticals is recalling Phenylephrine 40 mcg/mL injection syringes due to a lack of assurance of sterility.
Medaus, Inc. is recalling Hydroxy B12 5mg/mL vials because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 50 vials of Lidocaine 2% syringes because the company cannot ensure the products are sterile.