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.
Well Care Compounding Pharmacy is recalling Estradiol Valerate 20mg/mL vials due to GMP violations affecting sterility.
Pulmuone Foods is recalling specific lots of noodles with Beijing Style Black Bean Sauce because they contain undeclared milk.
Pulmuone Foods is recalling Korean Noodles in a Savory Black Bean Sauce because the product contains undeclared milk.
Well Care Compounding Pharmacy is recalling Itraconazole 0.2%/Mupirocin 0.2% Nasal Spray because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Gentamicin 15 mg/ml Ophthalmic Solution due to FDA inspection findings regarding sterility assurance.
Well Care Compounding Pharmacy is recalling specific lots of Clotrimazole 1%/Betamethasone Dipropionate 0.05% Otic Solution because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Methylcobalamin 1 mg/mL vials because FDA inspections found GMP violations that may impact product sterility.
Lee Seed Company is recalling Yogurt Super Soynuts because the product contains undeclared milk, posing a risk to individuals with milk allergies.
Novacare, LLC is recalling Thin and Slim Naturally AM dietary supplements because FDA sampling confirmed the presence of unapproved salicylic acid.
Novacare, LLC is recalling TruTrim dietary supplements marketed without FDA approval because they contain salicylic acid.
Well Care Compounding Pharmacy is recalling 869 vials of a compounded injectable vitamin mixture due to FDA inspection findings that raised concerns about product sterility.
Well Care Compounding Pharmacy is recalling TRI-MIX # 3 vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling levocarnitine 100mg/mL vials because FDA inspections found GMP violations that may affect sterility.
Thor Motor Coach is recalling 2014-2016 Tuscany motor homes because the brake signal to towed devices may not deactivate, causing dragging brakes and fire risk.
GE Healthcare is recalling 97 MSK 1.5T Extreme MR Scanners because gas venting may not occur properly, posing a risk of oxygen deprivation.
Brown & Haley Inc. is recalling Mountain Thins Trail Mix flavor due to potential Listeria monocytogenes contamination.
Hill-Rom is recalling Liko Universal SlingBars because the center bolt may weaken and break, posing a risk of patient falls and injury.
Alimentos Congelados, S.A. is voluntarily recalling 1,800 cases of Wylwood Fresh Frozen Broccoli Cuts due to potential Listeria monocytogenes contamination.
Nuvi Global Corporation is recalling StemVitae Multivitamin bottles due to undeclared whey protein containing milk and soy lecithin.
Novacare, LLC is recalling Black Widow 25 Ephedra Super Potent Fat Burner because FDA sampling confirmed the presence of salicylic acid in the product.
Well Care Compounding Pharmacy is recalling Myers' Cocktail vials due to FDA inspection findings of GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling Vitamin B Complex # 3 vials because FDA inspections found GMP violations that may affect sterility.
Well Care Compounding Pharmacy is recalling 869 vials of Phosphatidylcholine/Deoxycholic Acid due to FDA inspection findings regarding sterility assurance.
Schulze & Burch Biscuit Co is recalling Aldi's Millville protein chew bars because a supplier reported a Listeria monocytogenes positive result for an ingredient.
Novacare, LLC is recalling Methyldrene Original 25 Ephedra ECA Stack dietary supplements because FDA sampling confirmed the presence of salicylic acid, an unapproved drug.