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, LLC is recalling Misoprostol 200 mcg tablets because they may be mislabeled as Propranolol HCl or Sodium Chloride.
Aidapak Services, LLC is recalling 25 mg Tramadol HCl tablets that may be mislabeled as Levothyroxine Sodium 137 mcg.
Specialty Medicine Compounding Pharmacy is recalling Glycerin-Chromated 72% Injectable because sterility cannot be assured after a related product was found non-sterile.
Aidapak Services, LLC is recalling Cholecalciferol/Calcium/Phosphorus tablets because they may be mislabeled as Promethazine HCl or Valsartan.
Specialty Medicine Compounding Pharmacy is recalling Lidocaine/Sodium Chloride injectable products because sterility cannot be assured after a related product was found non-sterile.
Aidapak Services is recalling Mirtazapine 7.5 mg tablets that may be mislabeled as Isoniazid 300 mg. The error poses a risk of incorrect medication administration.
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 Tropicamide 1% Ophthalmic Solution because sterility cannot be assured after a related product was found non-sterile.
Draeger Medical Systems is recalling 439 Infinity Acute Care System units because a high-grade SpO2 alarm may fail to activate after a medium-grade alarm is paused.
Specialty Medicine Compounding Pharmacy is recalling 0.9% Sodium Chloride injectable and topical products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Acetylcysteine 20% Ophthalmic solution because sterility cannot be assured after a related product was found non-sterile.
Jensen's Old Fashioned Smokehouse is recalling Hot Smoked Halibut because it may lack 'KEEP FROZEN' labeling and could be contaminated with Clostridium botulinum.
The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The products are intended for cutting and shaping bone.
Aidapak Services is recalling 1,998 docusate sodium capsules that may be mislabeled as 250 mg or tizanidine HCl tablets.
Josephson's Smokehouse is recalling hot smoked pepper Atlantic salmon because the products were undercooked, posing a potential hazard of Clostridium botulinum toxin formation.
Aidapak Services is recalling 2,299 Propranolol HCL 10 mg tablets due to potential mislabeling as other medications.
Specialty Medicine Compounding Pharmacy is recalling Naloxone HCL 0.4mg/mL injectable because sterility cannot be assured after a related product was found to be non-sterile.
Aidapak Services is recalling Nifedipine 10 mg capsules because they may be mislabeled as Nitrofurantoin 100 mg. The repacked drugs were distributed in four western states.
Atrium Medical Corporation is recalling 1,944 units of Express Dry Seal ATS Chest Drains because the tubing may leak or disconnect.
Aidapak Services, LLC is recalling FIDAXOMICIN 200 mg tablets that may be mislabeled as BENAZEPRIL HCL 40 mg. The error affects repacked drugs distributed in four western states.
Glass Onion Catering is recalling Trader Joe's Classic Greek Salad because an investigation linked the supplier to an E. coli O157:H7 outbreak.
Specialty Medicine Compounding Pharmacy is recalling Phenol, 6%, Injectable, because sterility cannot be assured after a related product was found non-sterile.
Aidapak Services, LLC is recalling 10 mg Citalopram tablets because they may be mislabeled as Oxybutynin Chloride or Coenzyme Q-10.
Aidapak Services is recalling Pimozide 2 mg tablets because they may be mislabeled as Duloxetine HCl 20 mg capsules.
Specialty Medicine Compounding Pharmacy is recalling Combo Eye Gel because sterility cannot be assured after another product was found non-sterile in the same environment.