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.
Oregon Compounding Centers is recalling Papaverine/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance.
Oregon Compounding Centers is recalling DMPS injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Hydroxocobalamin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling sterile glutaraldehyde solution for irrigation due to quality control issues affecting sterility assurance.
Oregon Compounding Centers is recalling AVASTIN syringes because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.
Innovative Trailer Design is recalling one 2014 V40TAN49 van trailer due to a potential pivot bolt crack that could cause the axle to separate.
Oregon Compounding Centers is recalling injectable Methylcobalamin due to quality control issues affecting sterility assurance.
Giorgio Foods Inc. is recalling bulk-packed Wheat Cheese Calzones due to potential metal contamination. The product was manufactured for the National School Lunch Program.
Wabash National is recalling 2014-2016 Van Trailers because defective brake actuators may cause dragging or overheating, increasing the risk of fire and crash.
Oregon Compounding Centers is recalling compounded Omnipaque injectable vials due to quality control issues affecting sterility assurance.
Oregon Compounding Centers is recalling Alprostadil/Lidocaine HCL vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
TriVascular is recalling specific lots of Ovation Prime Abdominal Stent Grafts because the fill polymer syringe may empty rapidly during the implant procedure.
Oregon Compounding Centers is recalling Estradiol Cypionate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Hydroxyprogesterone Caproate injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling sterile injectable drug vials due to quality control issues affecting sterility assurance.
Oregon Compounding Centers is recalling Tobramycin solution for irrigation due to quality control issues affecting sterility assurance.
Oregon Compounding Centers is recalling 117 vials of Chorionic Gonadotropin due to quality control issues affecting sterility assurance.
Baxter Healthcare Corp is recalling 94,224 INTRA VIA containers due to particulate matter found inside the fluid path.
Oregon Compounding Centers is recalling Papaverine/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Dancing Star LLC is recalling specific lots of Carob Supergreens Chunks of Energy and Rave Bites Carob Supergreens because they may be contaminated with Salmonella.
Oregon Compounding Centers is recalling injectable Methycobalamin vials due to quality control issues that present a potential risk to sterility assurance.
Oregon Compounding Centers is recalling injectable glutathione vials because quality control issues observed during an FDA inspection present a potential risk to sterility assurance.
Oregon Compounding Centers is recalling injectable glutathione vials due to quality control issues affecting sterility assurance identified during an FDA inspection.
Oregon Compounding Centers is recalling Vitamin B Complex injectable vials due to quality control issues affecting sterility assurance.
Oregon Compounding Centers is recalling specific lots of injectable Methycobalamin due to quality control issues affecting sterility assurance identified during an FDA inspection.