Hazard
55 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 55 sterility assurance failure recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (25%) 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 failure 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.
Vital Care Compounder is recalling Brilliant Blue G Solution due to inability to assure product sterility. The recall involves 86 vials (Lot 60448) distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Cipla recalls Arformoterol Tartrate Inhalation Solution due to environmental monitoring failure affecting sterility assurance.
Carolina Infusion is recalling TRI-MIX 30/2/20 Injectable due to lack of assurance of sterility. Multiple lots were distributed nationwide to healthcare providers.
SterRx is recalling 360 bags of fentanyl citrate IV medication due to lack of assurance of sterility. No illnesses have been reported.
Nephron Sterile Compounding Center is recalling 2,315 pre-filled syringes due to lack of sterility assurance. The compounded injectable medication was distributed nationwide.
Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The recall affects 10,700 syringes distributed nationwide.
Tailor Made Compounding recalls two batches of Alprostadil/Papaverine/Phentolamine injectable due to lack of sterility assurance. The recall affects 32 vials distributed nationwide and in Puerto Rico.
Nephron Sterile Compounding Center has recalled 3,532 bags of fentanyl citrate injection due to lack of sterility assurance. The affected lots (FN1088A and FN1089A) were distributed nationwide.
Olympia Compounding Pharmacy recalls a multi-drug injectable compound (lot B41C22-22) due to inability to assure sterility. The recall affects 1,159 vials distributed nationwide.
Olympia Compounding Pharmacy recalls 1282 vials of Cyanocobalamin 2 mg/mL due to lack of sterility assurance. The affected vials were distributed nationwide in the United States, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling Sermorelin Acetate injectable powder because of insufficient assurance of sterility. Patients using affected lots should contact their healthcare provider.
Olympia Compounding Pharmacy recalls QM-4, a multi-drug compounded injectable, due to lack of assured sterility. 914 vials distributed nationwide in the USA, Puerto Rico, and US Virgin Islands are affected.
Olympia Compounding Pharmacy is recalling 5,443 vials of Calcium Chloride 10% injectable due to lack of sterility assurance. The medication was distributed nationwide.
Akorn, Inc. is recalling 62,331 boxes of TheraTears Extra lubricant eye drops distributed nationwide due to lack of assured sterility. Non-sterile eye drops could pose infection risks.
Edge Pharma is recalling Cefuroxime sterile ophthalmic solution for injection because the company cannot assure the product meets sterility requirements. The recall affects approximately 1,720 syringes distributed nationwide.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable product containing testosterone cypionate, anastrozole, and dutasteride due to lack of assurance of sterility. The recall affects lot T1009092021:19 distributed across the United States.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Tri-Mix Papaverine/Phentolamine/PGE-1 injectable vials distributed across the United States and Puerto Rico due to lack of assurance of sterility.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-TEST 200 injectable medication due to lack of assurance of sterility. Affected lots include T1007302021:37 and T1008242021:04.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling an injectable drug product due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
Talon Compounding Pharmacy is recalling Methylcobalamin 5MG/ML injectable (Lot 07162021:70) distributed nationwide because the manufacturer cannot assure sterility of the product.
Vita Pharmacy, LLC (dba Talon Compounding Pharmacy) is recalling BCAA injectable vials due to lack of assurance of sterility. The affected product was distributed across the United States, Washington D.C., and Puerto Rico.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling TRI-MIX PAPAVERINE 15/PHENTOLAMINE 0.25/PGE-1 6 injectable vials due to lack of assurance of sterility. The injectable medication was distributed across the United States, including Washington, D.C. and Puerto Rico.
Talon Compounding Pharmacy is recalling CJC-1295 and Ipamorelin injectable vials distributed across the United States because the manufacturer cannot assure sterility of the products.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling a compounded injectable medication (QUAD-MIX) due to lack of assurance of sterility. The product was distributed across the United States, including Washington, D.C. and Puerto Rico.
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Test Cypionate 200mg/Dutasteride 1mg/ml Injectable due to lack of assurance of sterility. Affected lots include T1008312021:02 and T1007142021:62.