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.
Somerset Therapeutics is recalling Methocarbamol Injection USP (1,000 mg/10 mL vials) nationwide due to lack of assurance of sterility following bacterial contamination in media fill testing.
QuVa Pharma is recalling 1,765 cassettes of compounded epidural injection due to lack of sterility assurance. The affected lots were distributed nationwide to institutional and office locations.
American Contract Systems Inc is recalling 91 CRANI PACK cranial procedure kits because a critical component cannot be confirmed to meet sterility requirements, making them unsuitable for surgical use.
Hikma Injectables is recalling 1,800 ketamine injection syringes nationwide because tamper-evident seals are not attached to several syringes, compromising sterility assurance.
Hikma Injectables is recalling phenylephrine injections nationwide because tamper-evident seals on some syringes were not properly attached. Affected lot 243120003D has a use-by date of 03/11/2025.
Imprimis NJOF, LLC is recalling one lot of a compounded ophthalmic suspension due to failure of sterility assurance. The product may be contaminated and pose a risk of serious eye infection.
Medline Industries is recalling Namic Fluid Delivery Sets (lot 0000113381) because they lack sterility assurance, which could allow contamination during medical procedures.
Regeneron Pharmaceuticals recalled over 251,000 EYLEA (aflibercept) injection syringes distributed nationwide due to complaints of syringe breakage and concerns about sterility assurance in specific lots.
SSM Health Care is recalling 140 vials of fentanyl citrate injection because the manufacturer did not perform required process validation to ensure sterility.
SCA Pharmaceuticals recalls fentanyl 2,500 mcg/250 mL injection (548 bags) nationwide due to lack of assurance of sterility. The affected product may not meet pharmaceutical sterility standards required for injectable drugs.
SCA Pharmaceuticals is recalling phenylephrine HCl injection syringes nationwide due to inability to assure sterility. Patients using recalled lots should contact their healthcare provider.
Windstone Medical Packaging is recalling a surgical kit due to inability to guarantee sterility of the included saline. The recall affects 1,528 units distributed in Florida, Illinois, and California.
Pine Pharmaceuticals is recalling 4,972 syringes of Cefuroxime injectable medication due to lack of assurance of sterility. The compounded antibiotic was distributed nationwide.
Pine Pharmaceuticals is recalling Calcium Gluconate 2.5% inhalation solution due to lack of sterility assurance. Patients should stop using affected syringes and contact their healthcare provider.
Central Admixture Pharmacy Services Inc. is recalling hydromorphone syringes due to lack of assurance of sterility. The recall affects 274 syringes distributed nationwide.
Central Admixture Pharmacy Services is recalling fentanyl 50 mcg/mL injectable nationwide due to lack of assurance of sterility. The product was distributed in 100 mL bags (lot 17-275322, expires 10/3/2023).
Central Admixture Pharmacy Services Inc is recalling 3,384 phenylephrine syringes due to lack of assurance of sterility. The product was distributed nationwide.
Central Admixture Pharmacy Services Inc. is recalling fentanyl-bupivacaine injectable solution due to lack of sterility assurance. The recall affects 190 units (250 mL bags) distributed nationwide.
Central Admixture Pharmacy Services has recalled approximately 398 HYDROmorphone in dextrose 5% injectable syringes nationwide due to lack of assurance of sterility. Patients should contact their healthcare provider immediately.
Karl Storz Endoscopy is recalling 218 units of Five S 5 3x65 flexible intubation endoscopes because sterility assurance cannot be confirmed. The affected devices were distributed worldwide including throughout the United States and Canada.
Central Admixture Pharmacy Services is recalling 298 bags of oxyTOCIN 40 units IV bags nationwide due to lack of validation data for sanitization cycles, creating potential sterility concerns.
Central Admixture Pharmacy Services is recalling 140 bags of Neonatal TPN Starter Bag due to lack of validation data for sanitization cycles. The injectable nutrition product was distributed nationwide.
Central Admixture Pharmacy Services recalls Cardioplegia Solution due to lack of validation data for sanitization cycles, which cannot assure product sterility.
Central Admixture Pharmacy Services Inc. is recalling morphine injections nationwide due to inadequate validation of sterilization procedures, which poses a potential sterility risk.
FDA recalled 751 bags of oxyTOCIN added to Lactated Ringer's IV solution nationwide due to lack of validation data for decontamination cycles, which left sterility assurance unconfirmed.