Hazard
119 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 119 sterility defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 36 (30%) 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 defect 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 378 droptainers of PRED ACETATE/GATIFLOXACIN eye drops distributed in AL, LA, MS, and TN due to inability to guarantee manufacturing sterility. No illnesses have been reported.
Pharmacy Plus Inc.'s Lidocaine/Phenylephrine injectable solution is recalled due to manufacturing process deficiencies that cannot guarantee product sterility. The recall affects 389 syringes distributed in Alabama, Louisiana, Mississippi, and Tennessee.
Pharmacy Plus Inc. recalls 460 syringes of compounded Cefuroxime intravitreal solution distributed in Alabama, Louisiana, Mississippi, and Tennessee due to manufacturing sterility defect.
Carolina Infusion is recalling its TEST CYP/DHEA injectable steroid vials nationwide because the manufacturer cannot assure they are sterile. The recall affects 348 vials with lot numbers from June-August 2022.
Carolina Infusion is recalling TEST CYP 200 MG/ML Injectable due to the manufacturing process's inability to assure sterility. The affected lots were distributed nationwide; patients should not use the product.
Akorn, Inc. is recalling 82,689 tubes of Lidocaine Hydrochloride Jelly USP, 2%, due to cGMP deviations and turbidity discovered during sterility testing. The recall affects multiple lots distributed nationwide.
Nephron Sterile Compounding Center is recalling 184,370 syringes of Labetalol HCl Injection nationwide due to lack of assurance of sterility. Patients using the affected lots should contact their healthcare provider.
Nephron Sterile Compounding Center LLC is recalling 30,290 syringes of Ketamine Hydrochloride Injection due to lack of assurance of sterility. The injectable drug was distributed nationwide.
Olympia Compounding Pharmacy is recalling AT-6, a compounded injectable medication, due to lack of sterility assurance. The recall affects 528 vials from Lot K24409.
Olympia Compounding Pharmacy is recalling SB-6, a compounded injectable medication, due to lack of assurance of sterility. The recall affects 874 vials distributed nationwide, in Puerto Rico, and the US Virgin Islands.
Olympia Compounding Pharmacy is recalling Amino Blend injectable vials due to lack of assurance of sterility. Approximately 7,761 vials were distributed nationwide. The FDA has classified this as a Class II recall.
Olympia Compounding Pharmacy is recalling Lipostat-Plus vials nationwide due to lack of sterility assurance. Approximately 4,843 vials were distributed across the USA, Puerto Rico, and US Virgin Islands.
North American Custom Laboratories recalls BPC-157 injectable solution due to manufacturing deviations that compromise sterility assurance. The FDA classified this as a Class II recall affecting 778 vials distributed nationwide.
ARA-290 (Cibinetide Acetate) injection is recalled due to manufacturing deviations that call sterility into question. Patients should contact their healthcare provider, as 28 vials have been distributed nationwide.
Vitae Enim Vitae Scientific, Inc. is recalling papaverine hydrochloride injection nationwide due to manufacturing deviations that compromise sterility assurance in this intravenous drug product.
Vitae Enim Vitae Scientific, Inc. is recalling Phenobarbital Sodium Injection nationwide due to deviations from Current Good Manufacturing Practices (CGMP) that raise concerns about product sterility.
APS Pharmacy is recalling 73 vials of Testosterone Cypionate/Anastrozole oil due to lack of sterility assurance. The product was distributed nationwide including Puerto Rico.
Family Pharmacy of Statesville is recalling Methylcobalamin 1 mg/mL Injectable in 1 mL syringes (Lot #07282020@3) distributed in North Carolina because the manufacturer cannot assure the product meets sterility standards.
Family Pharmacy of Statesville is recalling one lot of Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags due to lack of assurance of sterility.
Edge Pharma, LLC is recalling Vancomycin HCl in 0.9% Sodium Chloride Injection due to lack of assurance of sterility. The 1,250 mg/250 mL pre-filled bags were distributed nationwide and may pose a safety risk if used.
Edge Pharma is recalling Mitomycin-C Sterile Ophthalmic Solution because the manufacturer cannot assure that the product is sterile. The recall affects 163 syringes distributed nationwide.
SterRx is recalling 1,428 bags of Norepinephrine in 5% Dextrose Injection nationwide due to lack of assurance of sterility. The product is a prescription injectable medication.
ROi CPS LLC is recalling regard Clinical Packaging Solutions Newborn Kits (Item 830096005) containing non-sterile needles. The kits were distributed to Missouri.
Pfizer is recalling one lot of 5% Dextrose Injection (50 mL ADD-Vantage Units) due to lack of sterility assurance; the bags have the potential to leak. This is a Class II recall affecting 765 bags distributed nationwide.
Talon Compounding Pharmacy is recalling Tri-Mix Papaverine injectable medication because the manufacturer lacks assurance of sterility. The affected lot was distributed across the United States, Washington D.C., and Puerto Rico.