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
Wells Pharmacy Network Llc
Vitamin D3 in Sesame Oil Injectable 50,000 IU/mL, 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·335 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Testosterone Cypionate in Grapeseed Oil Injectable, 100 mg/mL, a) 1mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·303 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Sermorelin Acetate/GHRP (2) 9 mg/9 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·158 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Trimix with Atropine Injectable 30 mg/3 mg/150 mcg/0.2 mg/mL, a) 2 mL b) 5 mL and 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·6 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
MIC/B12(M) 15 mg/50 mg/100 mg/1 mg/mL Injectable, 30 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·633 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Fluorescein/Indocyanine, Lyophilized (P.F.), 400 mg/15 mg, 1 mL, Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·203 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Arginine/Citrulline/Ornit+Lido 100/100/100/10 mg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
Injectable Drugs·30 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Titan Up (INOS/CHOL/LEU/CAR/CHRO/LID) Injectable 25 mg/25 mg/1.5 mg/25 mg/0.025 mg/10 mg/mL, 30 mL vial, Compounded by Wells Pharmacy, O...
Injectable Drugs·433 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Sermorelin Acetate/GHRP (6) 6 mg/3 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·1,232 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Bimix 30 mg/1 mg/mL Injectable, a) 5 mL and b) 10 mL vial, Compounded by Wells Pharmacy Network, LLC, Ocala, FL
Injectable Drugs·80 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Indocyanine Green (P.F.), 15 mg Injectable Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·131 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Testosterone Cypionate in Sesame Oil Injectable, (NY STATE), 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·3 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Trimix Injectable 17.65 mg/0.59 mg/5.9 mcg/mL a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·2 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Methylcobalamin Injectable (Dr. Hall Kit) - 1,000 mcg/mL, 30 mL vial Kit, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·7 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Trimix Injectable 30 mg/3 mg/60 mcg/mL, a) 2 mL, b) 5 mL and c) 10 mL vials, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·2 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·191 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Testosterone Enanthate in Grapeseed Oil Injectable, 200 mg/mL, 10 mL vial, Compounded by Wells Pharmacy, Ocala, FL
Injectable Drugs·1,250 affected·Sep 21, 2016
High RiskFDA
Wells Pharmacy Network Llc
Alprostadil 40 mcg/mL Injectable, 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
Injectable Drugs·37 affected·Sep 21, 2016
High RiskFDA
Leiter's Compounding
Cyclopentolate HCl 1% - Tropicamide 1% - PHENYLephrine HCl 2.5% in Sterile Water for Injection (Ophthalmic Solution), in a) 1 mL Total Vo...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Atropine Sulfate 0.01% in 0.9% Sodium Chloride (Ophthalmic Solution) 10 mL Total Volume in a 15 mL Dropper Bottle, Compounded by Leiter'...
Ophthalmic Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Brilliant Blue G 0.025% in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's ...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution (BSS) Intravitreal Injection, 1 mL Total Volume in a 2 mL Vial, Compounded by Lei...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leite...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Vancomycin 10 mg/mL in 0.9% Sodium Chloride (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded by Leiter's Com...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Leiter's Compounding
Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection (Injection) 1 mL Total Volume in a 2 mL Vial (Preservative Free), Compounded ...
Injectable Drugs·76,315 affected·Sep 20, 2016
High RiskFDA
Custom Medical Specialties, Inc.
CMS-2193-R7 and CMS-1911-R3 Custom Biopsy Tray containing a BD 10cc LL Syringe, Sterile, Manufactured for CMS Custom Medical Specialties,...
Medical Devices·80 affected·Sep 20, 2016
High RiskFDA
Hospira Inc., A Pfizer Company
Marcaine 0.25% (bupivacaine HCl) injection, USP, 125 mg/50 mL (2.5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest,...
Injectable Drugs·15 affected·Sep 16, 2016
High RiskFDA
Hospira Inc., A Pfizer Company
Marcaine 0.5% (bupivacaine HCl) injection, USP, 250 mg/50 mL (5 mg/mL), 50 mL Multiple-Dose Vial, Rx only, Hospira, Inc., Lake Forest, IL...
Injectable Drugs·4,768 affected·Sep 16, 2016
CriticalFDA
Vascular Solutions, Inc.
Vascular Solutions Twin-Pass .023" Dual Access Catheter, model 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual access cathet...
Surgical Devices·11,670 affected·Sep 16, 2016
CriticalFDA
Vascular Solutions, Inc.
Vascular Solutions Twin-Pass RX Dual Access Catheter, model 5210. Sterilized with Ethylene Oxide. The Twin-Pass dual access catheter ...
Surgical Devices·11,670 affected·Sep 16, 2016
CriticalFDA
Vascular Solutions, Inc.
Vascular Solutions Twin-Pass Dual Access Catheter, models 5200, 5210, and 5230. Sterilized with Ethylene Oxide. The Twin-Pass dual ac...
Surgical Devices·11,670 affected·Sep 16, 2016
High RiskFDA
Becton Dickinson & Company
BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
Medical Devices·22,400 affected·Sep 16, 2016
High RiskFDA
Hand Biomechanics Lab Inc
Agee-WristJack¿ Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and ex...
Medical Devices·65 affected·Sep 14, 2016
High RiskFDA
The Apothecary Shoppe Llc
Methylcobalamin 5000 mcg/mL Injection, packaged in 1, 2, 3, 4, and 5 mL vials, IM, Rx, The Apothecary Shoppe Compounding Pharmacy, Jenks, OK
Injectable Drugs·419 affected·Sep 12, 2016
High RiskFDA
The Apothecary Shoppe Llc
Tri-Mix 18/1/10 (Papaverine 18mg, Phentolamine 1 mg, Prostaglandin 10 mcg/mL) packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Sh...
Drugs·247 affected·Sep 12, 2016
High RiskFDA
The Apothecary Shoppe Llc
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials, IM, Rx, The Apothecary Shoppe, Jenks, OK
Drugs·455 affected·Sep 12, 2016
High RiskFDA
Greatbatch Medical
Greatbatch Stiffer Coaxial Micro-Introducer. Model #/ Name: 10904-001 Stiffer Coaxial Micro-Introducer 4FR; 10904-002 Stiffer Coaxial Mic...
Surgical Devices·23,075 affected·Sep 8, 2016
High RiskFDA
Banyan Medical, Llc
Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
Medical Devices·64 affected·Sep 7, 2016
High RiskFDA
United Exchange Corporation
Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp., 17211 Valley View Ave., Cerritos, CA 90703, Made in Korea...
Drugs·77,184 affected·Sep 2, 2016
High RiskFDA
United Exchange Corporation
Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby Laboratories, 31778 Enterprise Drive, Livonia, MI 48150, Ma...
Drugs·112,320 affected·Sep 2, 2016
High RiskFDA
United Exchange Corporation
EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical, 31778 Enterprise Drive, Livonia, MI 48150, Made in Korea, ...
Drugs·190,710 affected·Sep 2, 2016
High RiskFDA
Medtronic Navigation, Inc.
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouc...
Surgical Devices·100 affected·Sep 1, 2016
High RiskFDA
Medtronic Navigation, Inc.
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches...
Surgical Devices·100 affected·Sep 1, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with...
Medical Devices·200 affected·Aug 29, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog N...
Medical Devices·153 affected·Aug 29, 2016
High RiskFDA
Angiodynamics Inc. (navilyst Medical Inc.)
Xcela Power Injectable PICC Maximal Barrier Nursing Kit The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with ...
Medical Devices·75 affected·Aug 29, 2016