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.
Aidapak Services is recalling Quetiapine Fumarate tablets that may be mislabeled as Simvastatin. The FDA classifies this as a Class II recall.
Aidapak Services, LLC is recalling OXcarbazepine 150 mg tablets because they may be mislabeled as traZODone HCl 50 mg.
Aidapak Services, LLC is recalling Hydrocodone Bitartrate/Acetaminophen tablets because they may be mislabeled as Melatonin. The recall covers repacked drugs distributed in four western states.
Specialty Medicine Compounding Pharmacy is recalling Potassium Phosphate injectable products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Quad Mix and Super Quad Mix injectables because sterility cannot be assured after a related product was found non-sterile.
Big Blue Fisheries is recalling all smoked products because they may not have been properly cooked, posing a risk of Clostridium botulinum contamination.
Specialty Medicine Compounding Pharmacy is recalling Papav/Phentol/PG E1 injectable products because sterility cannot be assured after a related product was found non-sterile.
Aidapak Services, LLC is recalling Trazodone HCl 150 mg tablets because they may be mislabeled as Nicotine Polacrilex or Sennosides.
Jensen's Old Fashioned Smokehouse is recalling 14,628 lbs of hot smoked salmon in Washington due to potential Clostridium botulinum contamination and missing 'KEEP FROZEN' labels.
Aidapak Services, LLC is recalling Torsemide 10 mg tablets that may be mislabeled as Mexiletine HCl 200 mg capsules.
Josephson's Smokehouse is recalling hot smoked garlic pepper Atlantic salmon because the products were undercooked, posing a potential hazard of Clostridium botulinum toxin formation.
Aidapak Services, LLC is recalling 10,819 tablets of Calcium Carbonate +D3 because they may be mislabeled as Digoxin or Amantadine HCl.
Specialty Medicine Compounding Pharmacy is recalling Methocarbamol 100 mg/mL injectable because sterility cannot be assured after a related product was found non-sterile.
Atrium Medical Corporation is recalling 6,684 Ocean Water Seal Chest Drain ATS units because the chest drain tubing may leak or disconnect.
Specialty Medicine Compounding Pharmacy is recalling Aluminum Potassium Sulfate Sterile powder because sterility cannot be assured after a related product was found non-sterile.
Josephson's Smokehouse is recalling Hot Smoked Wine Maple Salmon because the products were undercooked, posing a potential hazard of Clostridium botulinum toxin formation.
Specialty Medicine Compounding Pharmacy is recalling Fluorouracil PF 50 mg/mL injectable because sterility cannot be assured after another product was found non-sterile in the same environment.
Aidapak Services is recalling 400 mg ibuprofen tablets that may be mislabeled as 325 mg aspirin. The repacked drugs were distributed in four western states.
Aidapak Services, LLC is recalling TACROLIMUS Capsules, 1 mg, because they may be mislabeled as LEVOTHYROXINE SODIUM Tablets, 125 mcg.
Aidapak Services is recalling 1,013 sodium bicarbonate tablets that may be mislabeled as nicotine polacrilex lozenges.
Specialty Medicine Compounding Pharmacy is recalling 204 doses of VIGAMOX (moxifloxacin) syringes because sterility cannot be assured after another product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Glutathione PF inhalation solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Bee International is recalling Sweet Spots Candy because it contains an undeclared egg allergen. The affected products were distributed nationwide in the US and Canada.
Jensen's Old Fashioned Smokehouse is recalling Hot Smoked Black Cod sold in Washington because it may lack 'KEEP FROZEN' labels and could be contaminated with Clostridium botulinum.
Big Blue Fisheries is recalling all smoked products because they may not have been properly cooked, posing a risk of Clostridium botulinum contamination.