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.
TMC Acquisition LLC is recalling Folic Acid 5mg/mL injectable vials due to lack of assurance of sterility. The recall affects 45 units distributed nationwide and in Puerto Rico.
TMC Acquisition LLC is recalling testosterone injectable products (58 vials) distributed nationwide and to Puerto Rico due to lack of assurance of sterility in manufacturing.
Sun Pharmaceutical is recalling medroxyprogesterone acetate injectable suspension (150 mg/mL) nationwide due to lack of assurance of sterility. Affected lots contain vials with expiration dates from December 2022 through September 2023.
Nephron Sterile Compounding Center is recalling 134,415 pre-filled syringes of Epinephrine Injection due to lack of assurance of sterility. Affected lots were distributed nationwide; patients and providers should contact their healthcare provider.
Nephron Sterile Compounding Center LLC is recalling Phenylephrine HCl Injection due to lack of assurance of sterility. Approximately 57,810 syringes were distributed nationwide.
Nephron is recalling 6,150 units of Glycopyrrolate Injection due to lack of sterility assurance. Healthcare providers should stop using affected lots and contact their supplier for return instructions.
Nephron Sterile Compounding Center is recalling Neostigmine Methylsulfate Injection due to lack of assurance of sterility. The compounded injectable drug may not meet sterile product standards.
Olympia Compounding Pharmacy recalls 2,333 vials of Sodium Selenite 200 mg/mL injection due to a lack of assurance of sterility. The product was distributed nationwide in the USA, Puerto Rico, and the U.S. Virgin Islands.
Olympia Compounding Pharmacy is recalling SB-5, a multi-dose injectable medication, due to lack of assurance of sterility. The product was distributed nationwide; patients should contact their healthcare provider immediately.
Olympia Compounding Pharmacy is recalling 1,466 vials of Sodium Bicarbonate 8.4% Multi-Dose Injectable (Lot L41002) due to lack of assurance of sterility. The product was distributed nationwide.
Olympia Compounding Pharmacy is recalling an injectable medication vial due to lack of sterility assurance. The recall affects 606 vials distributed nationwide, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling Vitamin D3 injectable vials due to lack of sterility assurance. A total of 3,083 vials were distributed nationwide.
Olympia Compounding Pharmacy is recalling pharmaceutical diluent vials due to lack of sterility assurance. The product was distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Olympia Compounding Pharmacy is recalling Myers Cocktail injectable vials due to lack of assurance of sterility. The recall affects approximately 13,679 vials distributed nationwide.
Sermorelin Acetate injectable (76 vials) recalled nationwide due to manufacturing deviations that compromise sterility assurance. No illnesses reported.
North American Custom Laboratories is recalling LL-37 2 mg/mL injectable vials due to manufacturing process deviations that raise questions about product sterility. The company distributed 25 vials nationwide.
Melanotan II injection (35 vials) is being recalled nationwide due to manufacturing deviations that could compromise product sterility. Patients should not use affected lots and should contact their healthcare provider.
Family Pharmacy of Statesville is recalling Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags because the manufacturer cannot assure the product meets sterility requirements.
Family Pharmacy of Statesville is recalling four bags of Hydromorphone HCl 1 mg/mL (250 mL each) distributed in North Carolina due to lack of assurance of sterility. The affected lots have beyond-use dates of October 25–30, 2020.
Ideal Specialty Apothecary is recalling Medroxyprogesterone Acetate Injection due to lack of assurance of sterility. The recall affects approximately 57,994 vials distributed nationwide.
Edge Pharma is recalling phenylephrine injection (20 mg/250 mL) because the manufacturer cannot assure the product maintains sterility. The recall affects 3,930 bags distributed nationwide.
Edge Pharma is recalling Lidocaine HCl Sterile Buffered Solution for Injection (1%, 10 mL syringes) due to lack of assurance of sterility. The recall affects approximately 4,465 syringes distributed nationwide.
Edge Pharma is recalling Moxifloxacin sterile ophthalmic injection syringes nationwide due to lack of assurance of sterility. The 860 affected syringes were distributed across two lots.
Edge Pharma, LLC is recalling Phenylephrine HCl 0.5 mg/5mL single-use syringes for intravenous injection nationwide due to lack of assurance of sterility. The affected product was distributed between September 2021 and January 2022.
Edge Pharma is recalling a combination ophthalmic solution (Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac) distributed nationwide due to lack of assurance of sterility. The product is used for topical eye application.