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.
Specialty Medicine Compounding Pharmacy is recalling Dexamethasone Sodium Phosphate solution because sterility cannot be assured after a related product was found non-sterile.
Aidapak Services is recalling Warfarin Sodium 0.5 mg tablets because they may be mislabeled as Sodium Chloride 1 mg tablets.
Aidapak Services is recalling Pramipexole tablets that may be mislabeled as Misoprostol. The error could lead to patients receiving the wrong medication.
Specialty Medicine Compounding Pharmacy is recalling methylcobalamin injectable products because sterility cannot be assured after a related product was found to be non-sterile.
Jensen's Old Fashioned Smokehouse is recalling hot smoked trout and Arctic Char because they may lack 'KEEP FROZEN' labels, posing a risk of Clostridium botulinum contamination.
Specialty Medicine Compounding Pharmacy is recalling all unexpired sterile compounded human and veterinary products because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Aidapak Services is recalling Lanthanum Carbonate Chew Tablets due to a potential label mixup with other medications. The repacked drugs were distributed in four western states.
Specialty Medicine Compounding Pharmacy is recalling Testos Cypionate injectable products because sterility cannot be assured after a related product was found non-sterile.
Aidapak Services, LLC is recalling GuaiFENesin ER 600 mg tablets because they may be mislabeled as other prescription drugs.
Big Blue Fisheries is recalling all smoked products because they may not have been properly cooked, posing a risk of Clostridium botulinum contamination.
Aidapak Services, LLC is recalling multivitamin tablets that may be mislabeled as lisinopril. The error could lead to patients taking the wrong medication.
Big Blue Fisheries is recalling all smoked products because they may not have been properly cooked, posing a risk of Clostridium botulinum contamination.
Aidapak Services is recalling Pantoprazole Sodium 20 mg tablets because they may be mislabeled as Dronedarone HCL 400 mg.
Aidapak Services, LLC is recalling Letrozole 2.5 mg tablets that may be mislabeled as Metoprolol Tartrate 50 mg. The error could lead to patients receiving the wrong medication.
Atherstone Foods Inc dba Glass Onion Catering is recalling Wheat Berry Salad kits because an investigation linked the supplier to an E. coli O157:H7 outbreak.
Specialty Medicine Compounding Pharmacy is recalling cyanocobalamin injectable products because sterility cannot be assured after a related product was found non-sterile.
Atherstone Foods Inc dba Glass Onion Catering is recalling Delish Asian Style Noodle Salad because an investigation linked the supplier to an outbreak of E. coli O157:H7.
North Pacific Seafoods is recalling Sitka Sound Seafoods Hickory Smoked Salmon due to potential Clostridium botulinum contamination and lack of thermal processing records.
Specialty Medicine Compounding Pharmacy is recalling Phenylephrine/Tropicamide ophthalmic solution because sterility cannot be assured due to environmental contamination risks.
Specialty Medicine Compounding Pharmacy is recalling Quad Mix injectable products because sterility cannot be assured after a related product was found non-sterile.
Aidapak Services is recalling Aspirin tablets that may be mislabeled as Cholecalciferol. The FDA classifies this as a Class II recall.
Specialty Medicine Compounding Pharmacy is recalling sodium tetradecyl sulfate injectable because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Proparacaine HCl ophthalmic solution because sterility cannot be assured due to shared compounding practices with a non-sterile product.
Specialty Medicine Compounding Pharmacy is recalling Papaverine HCL injectable because sterility cannot be assured after another product was found non-sterile in the same environment.
Specialty Medicine Compounding Pharmacy is recalling Epinephrine products because sterility cannot be assured after a related product was found non-sterile.