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.
Pharmakon Pharmaceuticals is recalling Bupivacaine HCI 0.125% bags due to a lack of assurance of sterility. The recall affects 55 units distributed nationwide.
Pharmakon Pharmaceuticals is recalling 24 bags of compounded Norepinephrine 16 mg in 0.9% sodium chloride due to a lack of assurance of sterility.
Medaus, Inc. is recalling specific lots of Folic Acid 10mg/mL vials because the company cannot ensure the product is sterile.
Medaus, Inc. is recalling specific lots of Germanium Seso 100mg/mL vials because the FDA determined there is a lack of assurance of sterility.
Medaus, Inc. is recalling specific lots of Methyl B12 and Pyridoxine vials because the company cannot guarantee the product is sterile.
Pharmakon Pharmaceuticals is recalling 275 vials of compounded Vecuronium 1mg/mL syringes due to a lack of assurance of sterility. The products were distributed nationwide and to specific VA/DOD facilities.
Pharmakon Pharmaceuticals is recalling 1,200 units of Rocuronium 10mg/ml syringes because the company cannot ensure the product is sterile.
Pharmakon Pharmaceuticals is recalling 595 bags of compounded Sufentanil and Bupivacaine due to a lack of assurance of sterility.
Pharmakon Pharmaceuticals is recalling 1,500 syringes of Fentanyl Citrate 50 mcg/mL because the company cannot ensure the products are sterile.
Medaus, Inc. is recalling DMPS 50mg/mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
Blue Bird is recalling 2016-2017 Vision transit buses with 6.8L Ford engines and Gen 3 propane units because fuel lines may rub, causing leaks and fire risk.
Charles Machine Works is recalling 2016 Ditch Witch T14MV trailers because an incorrect wiring harness may prevent brakes from applying if the trailer separates from the tow vehicle.
Blue Bird is recalling 2,902 school buses due to propane fuel lines that may rub and leak, increasing the risk of fire.
BMW is recalling 956 model year 2015 M5 and M6 vehicles because a defective driveshaft weld may cause loss of propulsion or vehicle rolling, increasing crash risk.
Spartan Motors is recalling 2011-2015 Transit Bus Chassis Cabs because frames may crack, potentially reducing driver control and increasing crash risk.
Bar-S Foods is recalling approximately 372,684 pounds of chicken and pork hot dog and corn dog products due to possible Listeria monocytogenes contamination.
ConAgra Foods is recalling approximately 195,597 pounds of frozen P.F. Chang's Home Menu chicken and beef products due to potential metal contamination. No injuries have been reported.
U.S. Cado Holdings is recalling approximately 29,645 pounds of imported frozen Swai fillets that entered U.S. commerce without meeting federal residue testing requirements.
Flushmate is recalling about 453,000 Flushmate III Pressure-Assist Flushing Systems in the U.S. because the units can burst, posing impact and laceration hazards.
Cantrell Drug Company is recalling 3,853 syringes of Midazolam HCl injection because the drug was subpotent. The recall is voluntary and nationwide.
The Pictsweet Company is recalling specific lots of frozen chopped onions due to possible Listeria monocytogenes contamination. The recall affects Kroger and Pictsweet brands distributed nationwide.
Cantrell Drug Company is recalling 884 syringes of fentanyl citrate injection because the drug was subpotent. The recall is voluntary and nationwide.
The Pictsweet Company is recalling specific lots of frozen seasoning blends due to potential Listeria monocytogenes contamination in the onion ingredients.
Reliable Drug is recalling compounded lidocaine, meloxicam, diclofenac, and baclofen products due to a lack of processing controls.
Cantrell Drug Company is recalling fentanyl citrate injection syringes because they contain less active drug than labeled.