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.
Baxter Healthcare is recalling Milrinone Lactate in Dextrose Injection because customer complaints reported leaks, creating a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling 5-MTHF SDV 5mg/mL injections because the firm cannot assure the sterility of the compounded drugs.
Key Pharmacy and Compounding Center is recalling TRI MIX 30/30/1 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Procaine HCL 1% injections because the firm cannot assure the products are sterile.
Key Pharmacy and Compounding Center is recalling 25 vials of Methyl-B12 injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.
Key Pharmacy and Compounding Center is recalling TRI MIX 10/15/2.5 5ML MDV MCG/MG/MG/ML INJ due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling Atropine Sulfate 0.5% Ophthalmic Solution because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling 26 vials of Methyl-B12 injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling specific lots of Magnesium Sulfate 50% injections because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling specific lots of Sodium Chloride Inhalation Solution because the firm cannot assure the sterility of the product.
Key Pharmacy and Compounding Center is recalling specific lots of TRI MIX injection due to a lack of assurance of sterility.
Sorin Group is recalling 37 implanted defibrillators because battery depletion may be undetectable. Physicians are being notified to monitor affected patients.
Key Pharmacy and Compounding Center is recalling PGE1/CPZ 5ML MDV 20MCG/1MG/ML INJ due to lack of assurance of sterility. The recall affects 2 vials distributed in the U.S., Australia, and Canada.
Key Pharmacy and Compounding Center is recalling PGE1 5ML MDV INJ, 40mcg/mL, due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.
Daimler Trucks North America is recalling 2013-2018 Freightliner Custom Chassis S2G trucks because improperly routed hoses and wires may contact the exhaust pipe, increasing fire risk.
Baxter Healthcare is recalling Fluconazole Injection bags because customer complaints indicated leaks that compromise sterility assurance.
Key Pharmacy and Compounding Center is recalling TRI MIX 5/30/0.5 injection vials because the firm cannot ensure the sterile compounded drugs are free from contamination.
Key Pharmacy and Compounding Center is recalling 25 vials of TRI MIX 20/20/1 injection due to a lack of assurance of sterility. The product was distributed in the U.S., Australia, and Canada.
Key Pharmacy and Compounding Center is recalling specific lots of Sodium Carboxymethylcellulose 0.5% Ophthalmic Solution because the firm cannot ensure the product is sterile.
Key Pharmacy and Compounding Center is recalling specific lots of Quad Mix injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling TRI MIX 20/30/0.5 injection vials due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling a specific lot of TRI MIX injection due to a lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling PGE1 MDV 20mcg/mL injections due to a lack of assurance of sterility. The affected products were distributed in the U.S., Australia, and Canada.
Key Pharmacy and Compounding Center is recalling CHOL/IN/ME(L)/B6 10ML MDV injection due to lack of assurance of sterility.
Key Pharmacy and Compounding Center is recalling a specific lot of compounded ferric gluconate injection due to a lack of assurance of sterility.