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 Cyclopentolate HCL ophthalmic products because sterility cannot be assured after a related product was found non-sterile.
Aidapak Services is recalling Hyoscyamine Sulfate tablets because they may be mislabeled as Azathioprine or Cholecalciferol.
Specialty Medicine Compounding Pharmacy is recalling Neomycin Sulfate ophthalmic solution because sterility cannot be assured after a related product was found non-sterile.
Aidapak Services is recalling Calcium Citrate tablets that may be mislabeled as Lithium Carbonate ER. The error could lead to incorrect medication administration.
Aidapak Services, LLC is recalling Olanzapine 7.5 mg tablets because they may be mislabeled as Levothyroxine or Mirtazapine. The repacked drugs were distributed in four western states.
Jensen's Old Fashioned Smokehouse is recalling Jack's Fish Spot Hot Smoked Atlantic Garlic & Pepper Chunks because the product may lack 'KEEP FROZEN' labeling and could be contaminated with Clostridium botulinum.
Aidapak Services, LLC is recalling Tizanidine HCl tablets that may be mislabeled as Pyridoxine HCl. The error could lead to patients taking the wrong medication.
Aidapak Services, LLC is recalling Vitamin B Complex with C/Folic Acid tablets because they may be mislabeled as other prescription or over-the-counter medications.
Specialty Medicine Compounding Pharmacy is recalling Hyaluronidase products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Hydroxyprogesterone 17alpha-PF 250 mg/mL injectable because sterility cannot be assured after a related product was found non-sterile.
Aidapak Services is recalling HydrALAZINE HCl tablets because they may be mislabeled as other prescription drugs. The recall covers repacked drugs distributed in four western states.
Zip International Group LLC is recalling Fosforel Atlantika Herring Fillets in Oil after Listeria monocytogenes was detected in samples.
Specialty Medicine Compounding Pharmacy is recalling Calcium Chloride PF 500 mg/mL prefilled syringes because sterility cannot be assured after a related product was found non-sterile.
Jensen's Old Fashioned Smokehouse is recalling Jack's Fish Spot Hot Smoked Cajun Atlantic Salmon because it may lack 'KEEP FROZEN' labeling, posing a risk of Clostridium botulinum contamination.
Aidapak Services is recalling Pimozide 1 mg tablets that may be mislabeled as Metoprolol Tartrate 12.5 mg. The error poses a risk of incorrect medication administration.
Concertos In Chocolate LLC is recalling Solid Milk Chocolate Santa candy because it is incorrectly labeled and contains an undeclared milk allergen.
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 Sodium Phosphate injectable products because sterility cannot be assured after a related product was found non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Sodium Thiosulfate PF, 10% injectable, because sterility cannot be assured after another product was found non-sterile in the same environment.
Aidapak Services is recalling Glucosamine/Chondroitin DS tablets because they may be mislabeled as Docusate Sodium capsules. The error could lead to patients taking the wrong medication.
Jensen's Old Fashioned Smokehouse is recalling hot smoked sturgeon because inconsistent 'KEEP FROZEN' labeling creates a risk of Clostridium botulinum contamination.
Specialty Medicine Compounding Pharmacy is recalling WB-Tranexamic acid products because sterility cannot be assured after a related product was found to be non-sterile.
Specialty Medicine Compounding Pharmacy is recalling Sodium Hydroxide 10% Solution because sterility cannot be assured after a related product was found non-sterile.
B&W Custom Truck Beds is recalling specific Tow & Stow Adjustable Ball Mounts because the securing pins may fracture, potentially causing the trailer to separate from the vehicle.
Gusto Packing is recalling approximately 67,113 pounds of sliced spiral ham products due to possible Listeria monocytogenes contamination. The products were distributed in Illinois, Indiana, Kentucky, Ohio, and Canada.