Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Synthes (usa) Products Llc
TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur...
Medical Devices·5 affected·Feb 1, 2023
RecallFDA
Akorn, Inc.
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Op...
Topical Drugs·45,117 affected·Jan 30, 2023
High RiskFDA
Carefusion 2200 Inc
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG...
Medical Devices·5,952 affected·Jan 30, 2023
High RiskFDA
Nephron Sc Inc
S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By...
Drugs·925,920 affected·Jan 13, 2023
High RiskFDA
Nephron Sc Inc
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, ...
Drugs·387,000 affected·Jan 13, 2023
High RiskFDA
Summit Medical, Llc
Summit Medical Nasal Septal Button, Medium, 5cm, REF SP-78105, sterile.
Medical Devices·30 affected·Jan 13, 2023
High RiskFDA
Nephron Sc Inc
Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, R...
Injectable Drugs·389,730 affected·Jan 12, 2023
High RiskFDA
Nephron Sterile Compounding Center Llc
Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing...
Injectable Drugs·38,830 affected·Jan 6, 2023
High RiskFDA
Northern Va Compounders Pllc
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vi...
Injectable Drugs·78 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounde...
Injectable Drugs·2 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx...
Injectable Drugs·8 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock H...
Injectable Drugs·2 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-D...
Injectable Drugs·2 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Ph...
Injectable Drugs·1,200 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, R...
Injectable Drugs·2 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Wa...
Injectable Drugs·4 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way...
Injectable Drugs·2 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx ...
Injectable Drugs·750 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Onl...
Injectable Drugs·2 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Wa...
Injectable Drugs·2 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compound...
Injectable Drugs·4 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compo...
Injectable Drugs·8 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way...
Injectable Drugs·108 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Do...
Injectable Drugs·6 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Onl...
Injectable Drugs·36 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL Multiple...
Injectable Drugs·12 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounde...
Injectable Drugs·4 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounde...
Injectable Drugs·2 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compoun...
Injectable Drugs·4 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded...
Injectable Drugs·525 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple...
Injectable Drugs·39 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Do...
Injectable Drugs·56 affected·Dec 30, 2022
High RiskFDA
Northern Va Compounders Pllc
Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 R...
Injectable Drugs·4 affected·Dec 30, 2022
High RiskFDA
Pfizer Inc.
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-5...
Injectable Drugs·62,088 affected·Dec 29, 2022
High RiskFDA
Sentara Infusion Services
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML...
Drugs·37 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, use with home pump, Sentara Home Infusion Pharmacy Services, ...
Drugs·18 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
METRONIDAZOLE 500MG 100ML, antibiotic, Rx Only, use with a home pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independenc...
Drugs·30 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
IMIPENEM/CILASTATIN 2000MG IN NS 400ML, antibiotic, Rx Only, use with a Curlin Pump, Sentara Home Infusion Pharmacy Services, 535 Indepe...
Drugs·7 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (c) TPN: AA 80GM ; DEX 320GM ; LIP 50GM IN 2300 ml,...
Drugs·24 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML, (d)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (e) 55GM...
Drugs·26 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
CEFOXITIN (a) 1GM IN NS 50ML,(b) 2GM IN NS 100ML, used with a home pump. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, ...
Drugs·3 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy...
Drugs·22 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Ches...
Drugs·7 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c) 108GM/AA, 330GM/DEX, 60GM/LIP 3000ML, (d) 37GM/AA, 160GM/DE...
Drugs·111 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Se...
Drugs·71 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste...
Drugs·14 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, C...
Drugs·14 affected·Dec 27, 2022
High RiskFDA
Sentara Infusion Services
MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML, antibiotic, Rx Only, use with home pump or no pump, Sentara...
Drugs·91 affected·Dec 27, 2022