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.
Prinston Pharmaceutical Inc is recalling Irbesartan and Hydrochlorothiazide tablets because FDA labs found the impurity NDEA above acceptable levels.
Prinston Pharmaceutical Inc. is recalling Irbesartan and Hydrochlorothiazide tablets because FDA testing found N-nitrosodimethylamine (NDEA) above the acceptable daily intake level.
Aisin World Corp. of America is recalling Transmission Control Modules for 2016-2019 Mazda Miata MX-5 and 2017-2019 Fiat 124 vehicles. Incorrect programming may cause unexpected downshifting and abrupt deceleration.
West Pharma Services IL, Ltd. is recalling Vial2BAG DC 13mm devices due to reported adverse events and potential inadequate drug admixing.
Prinston Pharmaceutical Inc. is recalling Irbesartan 300 mg tablets because FDA testing found N-nitrosodimethylamine (NDEA) levels above the interim acceptable daily intake.
Subaru is recalling 2019 Forester and Crosstrek vehicles because a steering connector may short circuit, causing a loss of power steering assistance.
Edwards Lifesciences is recalling 875 units of Swan Ganz Thermodilution Catheters because incorrect lumen assembly causes reversed pressure readings.
Lupin Pharmaceuticals is recalling 14,400 bottles of Cephalexin for Oral Suspension due to CGMP deviations and the presence of extraneous material in sucrose excipients.
Richwell Group is recalling approximately 73,360 pounds of frozen Sheat fish products that were imported from Vietnam without the required benefit of import inspection.
Hyundai is recalling 2011-2013 Tucson vehicles because the engine oil pan may leak, potentially causing engine damage, fire, or stalling.
Chrysler is recalling 2019 Ram 1500 trucks with adjustable pedals because the brake pedal may separate from the assembly, increasing crash risk.
Chrysler is recalling 2017-2019 Fiat 124 Spider vehicles with automatic transmissions due to a software defect that may cause unexpected downshifting and sudden deceleration.
Q's American Best Trading Inc. is recalling approximately 1,008 pounds of imported frozen Sheat fish products that were not presented for import re-inspection.
Pilgrim's Pride is recalling approximately 58,020 pounds of frozen, uncooked breaded popcorn chicken products due to possible contamination with rubber.
Mazda is recalling 2016-2019 MX-5 vehicles with automatic transmissions because incorrect software may cause unexpected downshifting and abrupt deceleration.
Forest River is recalling 2019 Rockwood and Flagstaff trailers because improper wiring may prevent brakes from engaging if the trailer disconnects from the tow vehicle.
Daimler Vans is recalling 2019 Mercedes-Benz Sprinter VS30 vehicles because the steering shaft may disconnect, causing a sudden loss of steering control.
Bound Tree Medical is recalling Epi Safe Administration and Training Kits because the instructions recommend an unapproved epinephrine dosage for young children.
Bound Tree Medical is recalling 339 Curaplex Epi Kits because the instructions recommend an unapproved epinephrine dosage for young children.
Teleflex Medical is recalling Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially compromising the tool's security.
Del Monte is recalling Fiesta Corn seasoned with Red & Green Peppers because incorrect thermal processing may allow Clostridium botulinum growth.
Teleflex Medical is recalling 1,962 units of Percuvance Percutaneous Shafts because the distal tip may deform or break off during use, potentially requiring surgical intervention.
Proterra is recalling 2015-2018 Catalyst buses because a height control system may overload front tires, increasing crash risk.
Dr. Reddy's is recalling specific bottles of Ezetimibe and Simvastatin tablets because black speckles were observed on the tablets.
Draeger Medical is recalling 75 units of VentStar Basic (P) 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuit.