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
Fresenius Kabi Usa Llc
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 2...
Injectable Drugs·963,000 affected·Sep 17, 2021
High RiskFDA
Integradose Compounding Services Llc
ceFAZolin 3 G in 0.9% Sodium Chloride, 115 mL Bag for Injection, Sterile Product, IntegraDose Compounding Services, LLC, 719 Kasota Ave S...
Injectable Drugs·589 affected·Sep 17, 2021
High RiskFDA
Medtronic Perfusion Systems
Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit,...
Medical Devices·168 affected·Sep 13, 2021
High RiskFDA
Karl Storz Endoscopy
FIVE S 3.5x65, Flexible Intubation Videoscope, REF: 091361-01 (1 Unit), and 091361-06 (6 Units)
Medical Devices·532 affected·Sep 10, 2021
High RiskFDA
Akorn, Inc.
TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A...
Ophthalmic Drugs·62,331 affected·Sep 8, 2021
High RiskFDA
Fujifilm Irvine Scientific, Inc.
Vit Kit-Freeze is intended for use in assisted reproductive procedures for vitrification and storage of human oocytes (MII), pronuclear (...
Medical Devices·3,981 affected·Sep 8, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·15 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·0 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·846 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STE...
Surgical Devices·138 affected·Sep 2, 2021
High RiskFDA
W L Gore & Associates, Inc.
REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, ST...
Surgical Devices·187 affected·Sep 2, 2021
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx only NDC 68462-317-32
Injectable Drugs·28,658 affected·Aug 27, 2021
High RiskFDA
Glenmark Pharmaceuticals Inc., Usa
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., U...
Oral Drugs·5,362 affected·Aug 27, 2021
High RiskFDA
Avrio Health L.p
Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile Solution Avrio Health LP ...
Drugs·75,828 affected·Aug 26, 2021
High RiskFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Cardiac Devices·48,672 affected·Aug 24, 2021
High RiskFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Cardiac Devices·51,494 affected·Aug 24, 2021
High RiskFDA
Prescription Labs Inc Dba Greenpark
Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Ophthalmic Drugs·350 affected·Aug 18, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
PYRIDOXINE HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
METHYLCOBALAMIN 10,000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021
High RiskFDA
First Royal Care Co. Llc, Dba Red Mountain Compounding Pharmacy
MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx
Drugs·0 affected·Aug 13, 2021