Hazard
663 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 663 sterility assurance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 261 (39%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterility assurance recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Red Mountain Compounding Pharmacy is recalling Dexpanthenol 250mg/mL injection solution due to FDA findings that sterility assurance cannot be confirmed. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling Benzalkonium Chloride 0.013% Solution due to lack of assurance of sterility identified during an FDA inspection. Approximately 494 patients in seven states received prescriptions for this product.
Red Mountain Compounding Pharmacy is recalling Calcium Gluconate 10% Injectable (PF) due to lack of assurance of sterility following an FDA inspection. The product was distributed to approximately 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling testosterone cypionate 200mg/ml in sesame oil due to FDA concerns about lack of sterility assurance. The product was distributed to approximately 494 patients across seven states.
First Royal Care Co. LLC, operating as Red Mountain Compounding Pharmacy, is recalling Testosterone Ultra 250MG/ML in sesame oil due to lack of assurance of sterility identified during FDA inspection.
Red Mountain Compounding Pharmacy is recalling MIC 25/50/50MG/ML MDV injectable medication due to lack of assurance of sterility following an FDA inspection. Approximately 494 patients in seven states received prescriptions for the affected product.
Red Mountain Compounding Pharmacy is recalling a testosterone-blend injection product due to FDA concerns about sterility assurance. The product was distributed to patients in seven states.
Red Mountain Compounding Pharmacy is recalling TEST CYP 25MG/ML in Ethyl Oleate because FDA inspection raised concerns about sterility assurance. Approximately 494 patients in seven states received prescriptions for this drug.
Red Mountain Compounding Pharmacy is recalling Cyclosporin 0.2% Oil Ophthalmic Suspension because FDA inspection identified concerns about sterility assurance. The recalled drug was distributed to approximately 494 patients across multiple states.
Red Mountain Compounding Pharmacy is recalling MIC/B12A/B6 injectable medication because FDA inspection identified concerns about sterility assurance. The recall affects 494 patients across seven states.
Red Mountain Compounding Pharmacy is recalling a methylcobalamin injectable solution after FDA inspection raised concerns about the lack of assurance of sterility.
Red Mountain Compounding Pharmacy is recalling Sodium Selenite 200mcg/ml injectable solution due to FDA inspection findings regarding lack of assurance of sterility. Approximately 494 patients in seven states received prescriptions for this product.
Red Mountain Compounding Pharmacy is recalling Magnesium Chloride 200 mg/mL injection because FDA inspection raised concerns about lack of assurance of sterility. The product was distributed to approximately 494 patients in seven states.
Smiths Medical is recalling over 933,000 medfusion Stopcock medical devices internationally due to lack of sterility assurance. The devices may not meet required sterility standards.
SSM Health Care St. Louis is recalling 385 bags of Potassium Chloride 40 mEq in 0.9% Sodium Chloride injection due to lack of assurance of sterility. The affected lot was distributed in Missouri.
Fresenius Kabi USA LLC is recalling 963,000 vials of Morphine Sulfate Injection because some vials are cracked, which compromises sterility assurance. The affected product was distributed nationwide.
New Vitalis Pharmacy is recalling Testosterone Cypionate and Testosterone Propionate injections nationwide due to lack of assurance of sterility. The recall affects 1,347 vials distributed across multiple lots.
Glenmark Pharmaceuticals is recalling Arformoterol Tartrate Inhalation Solution 15 mcg/2 mL nationwide because the manufacturer lacks assurance of sterility for affected lots.
Custopharm, Inc. is recalling Fludarabine Phosphate for Injection, USP 50 mg because the manufacturer detected microbial contamination during environmental monitoring in aseptic manufacturing areas, raising sterility assurance concerns.
Pi yen chin Ophthalmic Redness Reliever Drops are being recalled because they are actually manufactured as nasal drops and sterility cannot be assured. The product is labeled for ophthalmic use but does not meet the safety standards required for eye application.
Teva Pharmaceuticals is recalling Methylprednisolone Acetate Injectable Suspension USP 80 mg/mL due to lack of assurance of sterility. The recall affects single-dose and multi-dose vials distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals USA is recalling Norepinephrine Bitartrate Injection, USP 4 mg/4 mL vials due to lack of assurance of sterility. The product was distributed nationwide.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product is sterile. Patients using recalled lot should consult their healthcare provider.
Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection in 100 mg/vial 10 mL single-use vials due to lack of assurance of sterility. The recall affects approximately 476,275 vials distributed nationwide, including Puerto Rico.
Teva Pharmaceuticals USA is recalling Idarubicin Hydrochloride Injection 20 mg/20 mL vials nationwide due to lack of assurance of sterility. The recall affects 2,091 vials distributed across the United States and Puerto Rico.