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.
Waldoch Crafts is recalling 2018 Ford Transit shuttle vans with Freedman GO-ES foldaway seats. The seat cushion may fail to lock in a crash, posing an injury risk.
Chrysler is recalling 2019 Jeep Cherokee vehicles because loose front passenger seat mounting bolts may allow the seat to move in a crash, increasing injury risk.
Royale is recalling 2015-2017 Mercedes Sprinter-based mini coaches because the rear seat cushion may not stay locked in place during a crash or sudden stop.
Camber Pharmaceuticals is recalling Losartan Potassium tablets because trace amounts of the nitrosamine NMBA were detected in the active ingredient.
Advanced Pharma Inc. is recalling 140 syringes of Glycopyrrolate 0.6 mg/3 mL Injectable Solution because the company cannot ensure the product is sterile.
Advanced Pharma Inc. is recalling 1,850 syringes of Phenylephrine HCl Injectable Solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 360 bags of fentanyl injectable solution nationwide due to a lack of assurance of sterility.
AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.
Aurobindo Pharma USA is recalling Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA) in the active ingredient.
Rising Pharmaceuticals is recalling Valsartan Tablets 80 mg due to CGMP deviations and the detection of a trace amount of the impurity NDEA.
Aurobindo Pharma USA Inc. is recalling Amlodipine and Valsartan tablets because FDA analysis found trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Advanced Pharma Inc. is recalling 1,125 bags of Midazolam Injectable Solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 2,400 syringes of Hydromorphone HCl injectable solution nationwide due to a lack of assurance of sterility.
Aurobindo Pharma USA is recalling specific lots of Valsartan 80 mg tablets because FDA analysis confirmed trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Advanced Pharma Inc. is recalling 2,325 syringes of Morphine Sulfate 30 mg/30 mL Injectable Solution nationwide due to a lack of assurance of sterility.
Advanced Pharma Inc. is recalling 800 syringes of Phenylephrine HCl Injectable Solution due to a lack of assurance of sterility. The product was distributed nationwide.
American Health Packaging is recalling Valsartan Tablets 160 mg because a carcinogenic impurity was detected in the active ingredient.
Advanced Pharma Inc. is recalling 5,700 syringes of Neostigmine Methylsulfate Injection Solution because there is a lack of assurance of sterility.
CTL Medical is recalling 133 Hex Driver MIS units because the anti-toggle ring may separate during surgery, potentially causing pedicle screw construct failure.
Camber Pharmaceuticals is recalling Losartan Potassium tablets because trace amounts of the impurity NMBA were detected in the active ingredient.
AvKARE Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.
Legacy Pharmaceutical Packaging LLC is recalling Losartan Potassium Tablets, 100 mg, due to the presence of the impurity N-Methylnitrosobutyric acid (NMBA).
Aurobindo Pharma USA Inc. is recalling specific lots of Valsartan Tablets USP 320 mg because FDA analysis confirmed the presence of trace amounts of the impurity N-nitrosodiethylamine (NDEA).
Advanced Pharma Inc. is recalling 550 syringes of Esmolol HCl Injectable Solution due to a lack of assurance of sterility. The affected products were distributed nationwide.
Advanced Pharma Inc. is recalling 1,440 syringes of Heparin 5,000 Units/5mL Injectable Solution nationwide due to a lack of assurance of sterility.