Hazard
664 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 664 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 262 (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.
B. Braun Medical is recalling 756 bags of 0.9% sodium chloride injection (saline) due to potential leakage that could compromise sterility. The recall affects product distributed in Florida, New Jersey, and Pennsylvania.
Avanos Medical is recalling sterile extension sets distributed without expiration dates. Without proper dating, healthcare providers cannot verify sterility assurance, creating a potential patient safety risk.
A compounded injectable medication containing papaverine, phentolamine, and prostaglandin was recalled after FDA inspection found it was not produced under conditions that guarantee sterility. The product was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Pharmacy Plus, Inc. is recalling Moxifloxacin 0.15 mg/0.1 mL preservative-free eye drops in 1 mL syringes due to lack of assured sterility. FDA inspection found the manufacturing process could not guarantee the product's sterility.
Pharmacy Plus Inc. is recalling acetylcysteine 10% eye drop solution due to manufacturing issues that cannot guarantee sterility. Lot 66895 was distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Vital Care Compounder is recalling 7 syringes of Lidocaine-Epinephrine solution due to lack of sterility assurance. FDA inspection found the products cannot be guaranteed to be sterile.
Pharmacy Plus recalls 67 bottles of Cyclosporin 0.07% ophthalmic solution across four states due to manufacturing process that cannot guarantee sterility.
Vital Care Compounder is recalling a compounded injectable medication due to FDA findings that the manufacturing process failed to guarantee sterility. Two lots were distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Carolina Infusion is recalling MIC/B12 injectable vials due to lack of assurance of sterility. Affected lots were distributed nationwide.
Nephron is recalling 47,905 pre-filled syringes of Ketamine HCl Injection nationwide due to lack of sterility assurance. Users should contact the manufacturer for handling instructions.
Nephron Sterile Compounding Center is recalling del Nido Cardioplegia Solution due to lack of assurance of sterility. The 1765 bags affected were distributed nationwide.
Nephron Sterile Compounding Center is recalling Rocuronium Bromide Injection syringes nationwide due to lack of assurance of sterility. Approximately 6,340 syringes from lot RC2003B (expiration August 28, 2022) are affected.
Nephron Sterile Compounding Center LLC is recalling Atropine Sulfate Injection pre-filled syringes nationwide due to lack of assurance of sterility affecting approximately 13,340 syringes.
Nephron Sterile Compounding Center LLC is recalling Morphine Sulfate Injection due to lack of assurance of sterility. The recall affects 8,985 syringes distributed nationwide.
TMC Acquisition LLC is recalling specific batches of Hydroxocobalamin Preservative Free injectable due to lack of sterility assurance. The affected vials were distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling Teriparatide injectable syringes nationwide due to lack of assurance of sterility. Patients using affected batches should contact their healthcare provider immediately.
Tailor Made Compounding has recalled 182 vials of Melanotan I injectable due to lack of assurance of sterility. The affected vials were distributed nationwide and in Puerto Rico.
Tailor Made Compounding recalls Testosterone Cypionate injections due to lack of sterility assurance. The recall affects 4,219 vials distributed nationwide.
Tailor Made Compounding recalls 349 vials of Estradiol Cypionate 10mg/mL due to lack of assurance of sterility. The product was distributed nationwide in the USA and Puerto Rico.
TMC Acquisition LLC is recalling Testosterone Cypionate injectable vials (100mg/ml) due to lack of assurance of sterility. The recall affects 273 vials distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling Procaine HCL 2% injectable solution due to lack of sterility assurance. The recall affects 58 vials distributed nationwide.
Tailor Made Compounding is recalling Glutathione 200mg/ml injectable vials due to lack of assurance of sterility. The recall affects 485 vials distributed nationwide in the USA and Puerto Rico.
Tailor Made Compounding is recalling PT-141 10mg/mL vials nationwide due to inability to assure sterility. The recall affects 392 vials in 1mL and 2mL sizes distributed in 2022.
Tailor Made Compounding is recalling 176 vials of testosterone cypionate/propionate injectable due to lack of assurance of sterility. The product was distributed nationwide.
Tailor Made Compounding is recalling 924 vials of Methionine/Inositol/Choline B12 + Carnitine injectable compound nationwide due to lack of assurance of sterility.