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
Nephron Sterile Compounding Center Llc
Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton ...
Injectable Drugs·3,690 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Car...
Injectable Drugs·3,740 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, packaged in 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 S...
Injectable Drugs·6,900 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Ca...
Injectable Drugs·18,930 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
HYDROmorphone HCl Injection, USP, 10 mg/50 mL (0.2 mg/mL) syringes, 5 x 50 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per ca...
Injectable Drugs·22,805 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
del Nido Cardioplegia Solution 1000 mL (1000 mL) Single-Dose Container IV bag, 4 x 1 IV Bag per case, Rx Only, Nephron 503B outsourcing f...
Injectable Drugs·1,765 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL) syringes, 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, R...
Injectable Drugs·19,060 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Lidocaine HCl Injection, USP 2%, 100 mg/5 mL (20 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carto...
Injectable Drugs·64,380 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, USP IV bag, packaged in 10 x 1 IV Bag per case, Rx Only, Neph...
Injectable Drugs·1,810 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
EPINEPHrine Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton p...
Injectable Drugs·134,385 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Ketamine HCl Injection, USP, 50 mg/1 mL (50 mg/mL*) syringe, packaged in 5 x 1 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton pe...
Injectable Drugs·47,905 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Lidocaine HCl Injection, USP 1%, 50 mg/5 mL (10 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton...
Injectable Drugs·37,310 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
0.9% Buffered Lidocaine HCl (buffered in 8.4% Sodium Bicarbonate), 45 mg/5 mL (9 mg/mL) syringes, packaged in 5 x 5 mL Prefilled Syringes...
Drugs·1,380 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5...
Drugs·85,300 affected·Jun 30, 2022
High RiskFDA
Nephron Sterile Compounding Center Llc
Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5 Syringe...
Injectable Drugs·59,520 affected·Jun 30, 2022
High RiskFDA
Micro Therapeutics, Inc.
Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only
Medical Devices·8 affected·Jun 30, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day...
Ophthalmic Drugs·9 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Pataday, Once Daily Relief, Olopatadine hydrochloride ophthalmic solution 0.2%, Antihistamine, Eye Allergy Itch Relief, Once Daily, Steri...
Ophthalmic Drugs·1 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Ste...
Oral Drugs·23 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
Topical Drugs·40 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Asthmanefrin Racephinephrine Inhalation Solution Bronchodilator, For temporary relief of mild symptoms of intermittent asthma, Preservati...
Oral Drugs·1 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
Drugs·16 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0...
Ophthalmic Drugs·12 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Rel...
Ophthalmic Drugs·47 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Al...
Ophthalmic Drugs·12 affected·Jun 29, 2022
High RiskFDA
Mckesson Medical-surgical Inc. Corporate Office
Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.
Drugs·10 affected·Jun 29, 2022
High RiskFDA
Family Dollar Stores, Llc.
DR SCHOLLS ANTI FUNGAL SPRAY PWDER 4.7 OZ SKU 998250 PREMIER ANTFGL TLNFTT LQ SPRY 5.3 FL OZ SKU 911077 distributed to specific Famil...
Inhaled / Nasal Drugs·0 affected·Jun 23, 2022
High RiskFDA
Family Dollar Stores, Llc.
FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
Topical Drugs·0 affected·Jun 23, 2022
High RiskFDA
Jubilant Draximage Inc
Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manu...
Drugs·519 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various Angiography packs/trays
Medical Devices·57 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Breast Abdominoplasty Pack
Medical Devices·1 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various C-section packs
Medical Devices·24 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various convenience packs
Medical Devices·116 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various convenience packs
Medical Devices·118 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
D&C pack
Medical Devices·1 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various Port Insertion Packs
Medical Devices·2 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various ob/gyn packs
Medical Devices·15 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various eye packs, cataract packs
Medical Devices·4 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various neurology packs
Medical Devices·37 affected·Jun 16, 2022
High RiskFDA
American Contract Systems, Inc.
Various Pacemaker Packs, Cardio Thoracic Packs
Cardiac Devices·24 affected·Jun 16, 2022
High RiskFDA
Sun Pharmaceutical Industries Inc
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, Rx only, Distributed by: Sun Pharmaceutical Industrie...
Injectable Drugs·47,500 affected·Jun 10, 2022
CriticalFDA
Covidien Llc
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, a...
Surgical Devices·213,589 affected·Jun 8, 2022
CriticalFDA
Covidien Llc
Palindrome Precision HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Surgical Devices·25,765 affected·Jun 8, 2022
CriticalFDA
Covidien Llc
Palindrome H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Surgical Devices·26,474 affected·Jun 8, 2022
CriticalFDA
Covidien Llc
Palindrome SI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Surgical Devices·2,462 affected·Jun 8, 2022
CriticalFDA
Covidien Llc
Mahurkar Chronic Carbothane (Maxid) Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Surgical Devices·132,443 affected·Jun 8, 2022
High RiskFDA
Roi Cps Llc
Nonsterile convenience kits: (1) regard Item #830099008, CV01005H - CV Part 1 Bundle; and (2) regard Item #830019017, CV00214Q - CV.
Medical Devices·86 affected·Jun 3, 2022
High RiskFDA
Wright Medical Technology, Inc.
Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model #33620254, non-sterile, an instrument used with the INFINITY Total Ankle Sy...
Medical Devices·35 affected·Jun 2, 2022