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.
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot ensure the products are sterile.
Sorin Group is recalling specific implantable defibrillators because battery depletion may be undetectable, posing a risk to patients.
Ion Beam Applications is recalling two Proteus 235 proton therapy systems in Florida because the device may restart irradiation from the beginning after a pause instead of recalculating the dose.
Key Pharmacy and Compounding Center is recalling GSH/NAC inhalation solution because the firm cannot assure the product is sterile.
Key Pharmacy and Compounding Center is recalling 200 vials of TRI MIX 10/30/0.5 injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling TRI MIX 45.45/27.27/0.45 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling 214 vials of DMPS Acid injections because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling Alpha Lipoic Acid injections due to a lack of assurance of sterility. The affected product was distributed in the U.S., Australia, and Canada.
Key Pharmacy and Compounding Center is recalling specific lots of Ferric Gluconate Injection because the firm cannot guarantee the sterility of the compounded drug.
Key Pharmacy and Compounding Center is recalling specific lots of Atropine Sulfate 0.01% Ophthalmic Solution because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling DMSO 6.25% Ophthalmic Solution because the firm cannot ensure the product is sterile.
Key Pharmacy and Compounding Center is recalling GSH/NAC Inhalation Solution due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Quad Mix 50/30/1/0.2 injection because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling specific lots of Testosterone Injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling TRI MIX 13/30/0.8 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of PGE1/Procaine injections because the firm cannot guarantee the products are sterile.
Key Pharmacy and Compounding Center is recalling specific lots of Hydroxo-B12 injections because the firm cannot assure the sterility of the compounded drugs.
Key Pharmacy and Compounding Center is recalling 5-MTHF 10mL single-dose vials because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling 72 vials of HCG injections because the firm cannot assure the sterility of the compounded drugs.
Key Pharmacy and Compounding Center is recalling Procaine HCL 1% injections because the firm cannot assure the sterility of the compounded drugs.
Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 2% injections because the firm cannot guarantee the products are sterile.
Key Pharmacy and Compounding Center is recalling 5-MTHF injections because the firm cannot assure the products are sterile.
Key Pharmacy and Compounding Center is recalling 20 vials of Folic Acid 10mg/mL injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling Pyridoxal-5-Phosphate 50mg/mL injection vials due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling Hydroxo-B12 injections because the firm cannot guarantee the products are sterile.