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 Manganese Chloride 0.1mg/mL vials because the company cannot guarantee the product is sterile.
Pharmakon Pharmaceuticals is recalling 675 units of compounded Hydromorphone HCI IV bags due to a lack of assurance of sterility.
Medaus, Inc. is recalling Tryptophan 10mg/mL vials because the company cannot ensure the product is sterile. The recall affects 10mL and 50mL vials distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling specific lots of B-Complex with Methyl B12 and Lidocaine vials because the company cannot guarantee the product is sterile.
Medaus, Inc. is recalling specific lots of Magnesium Chloride 200mg/mL vials because the company cannot assure the sterility of the product.
Medaus, Inc. is recalling specific lots of Thiamine 100 mg/mL vials because the company cannot guarantee the product is sterile.
Pharmakon Pharmaceuticals is recalling 120 units of Hydromorphone HCI syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Hospira is recalling 8,216 PCA 3 infusion pumps because normal wear on a component may prevent the device from detecting distal occlusions, a defect that resulted in one serious injury.
Dr. Praeger's Sensible Foods is voluntarily recalling Ungar's Veggie Balls (Vegan) because they may be contaminated with Listeria monocytogenes.
Medaus, Inc. is recalling specific lots of Lipo-Injection vials because the FDA determined there is a lack of assurance of sterility.
Medaus, Inc. is recalling specific lots of Minoxidil 0.5% vials because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 25 units of Morphine Sulfate syringes because the company cannot guarantee the products are sterile.
Pharmakon Pharmaceuticals is recalling Morphine Sulfate syringes because the company cannot guarantee the products are sterile.
Pharmakon Pharmaceuticals is recalling Phenylephrine HCI 40mg/250 mL bags because the company cannot ensure the products are sterile.
Medaus, Inc. is recalling Thiamine 100 mg/mL vials because the company cannot assure the sterility of the product. The recall covers lots distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling specific lots of B-Complex Without B12 vials because the company cannot assure the sterility of the product.
Pharmakon Pharmaceuticals is recalling 150 bags of compounded Fentanyl Citrate and Ropivacaine HCI injection due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 2,300 units of compounded Ondansetron 2mg/mL syringes because the company cannot ensure the product is sterile.
Medaus, Inc. is recalling specific lots of Niacinamide 100 mg/mL vials because the company cannot guarantee the product's sterility.
Pharmakon Pharmaceuticals is recalling Ephedrine Sulfate 5 mg/mL syringes because the company cannot guarantee the products are sterile.
Pharmakon Pharmaceuticals is recalling 1,809 units of compounded Oxytocin infusion bags nationwide due to a lack of assurance of sterility.
Medaus, Inc. is recalling specific lots of L-Carnitine 100mg/mL vials because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling Fentanyl Citrate syringes because the company cannot ensure the products are sterile.
Hospira is recalling 53,151 LifeCare PCA Plus II infusion pumps because wear on a component may prevent the detection of distal occlusions, resulting in serious injury.
Pharmakon Pharmaceuticals is recalling 142 units of Provocholine pre-diluted syringes nationwide due to a lack of assurance of sterility.