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
Edge Pharma, Llc
Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per s...
Injectable Drugs·3,360 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per...
Injectable Drugs·1,202 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx On...
Injectable Drugs·3,930 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular In...
Injectable Drugs·0 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-...
Injectable Drugs·1,795 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Int...
Injectable Drugs·168 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colches...
Injectable Drugs·457 affected·Dec 6, 2021
High RiskFDA
Edge Pharma, Llc
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC ...
Injectable Drugs·5,335 affected·Dec 6, 2021
High RiskFDA
Pfizer Inc.
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/04...
Injectable Drugs·765 affected·Nov 30, 2021
High RiskFDA
Roi Cps Llc
Regard, T AND A - Rogers, sterilized convenience kits
Medical Devices·195 affected·Nov 30, 2021
High RiskFDA
Howmedica Osteonics Corp.
Triathlon Pro Tibial Preparation Tray, Revision AC- for organization, storage, and transport in preparation for sterilization of re-usabl...
Medical Implants·7 affected·Nov 24, 2021
High RiskFDA
Avanos Medical, Inc.
BALLARD* Multi-Access Port Catheter, Double Swivel Y Elbow, Adult, 14 French; Sterile; Single Use
Surgical Devices·6,280 affected·Nov 22, 2021
High RiskFDA
Avanos Medical, Inc.
BALLARD* Multi-Access Port (MAP) Catheter, Double Swivel Y- Adult, 16 French; Sterile; Single Use
Surgical Devices·2,520 affected·Nov 22, 2021
High RiskFDA
Avanos Medical, Inc.
BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement for Multi-Access Port (MAP) Catheter; Sterile; Single Use
Surgical Devices·20 affected·Nov 22, 2021
High RiskFDA
Asp Cares
Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock R...
Injectable Drugs·3,077 affected·Nov 17, 2021
High RiskFDA
Asp Cares
Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd S...
Injectable Drugs·1,605 affected·Nov 17, 2021
High RiskFDA
Asp Cares
Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd St...
Injectable Drugs·896 affected·Nov 17, 2021
High RiskFDA
Medshape, Inc.
DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
Medical Devices·26 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK884
Medical Devices·680 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core SMILE Pack 2-Beaver-Visitec- A Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery....
Medical Devices·1,170 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core LASIK Pack 2-Medical Refractive Kit- intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK...
Medical Devices·920 affected·Nov 17, 2021
High RiskFDA
Beaver Visitec International, Inc.
Malosa Core Phaco Pack 1-Medical Cataract Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part Number: MMK833/2
Medical Devices·120 affected·Nov 17, 2021
High RiskFDA
Sterrx, Llc
MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 129...
Injectable Drugs·880 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7...
Injectable Drugs·1,044 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Injection, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC...
Injectable Drugs·36,576 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 1290...
Injectable Drugs·74,508 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 1...
Injectable Drugs·10,660 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
PHENYLephrine HCl, 40 mg per 250 mL, (160 mcg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY...
Injectable Drugs·20,640 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL, Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903,...
Injectable Drugs·3,540 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903...
Injectable Drugs·127,260 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave. Plattsburgh, NY 12003, NDC #7...
Injectable Drugs·15,660 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7...
Injectable Drugs·40 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903,...
Injectable Drugs·24,300 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC...
Injectable Drugs·36,360 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 1290...
Injectable Drugs·121,584 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
Injectable Drugs·2,886 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, N...
Drugs·18,948 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7032...
Injectable Drugs·9,360 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 mcg per mL), Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY...
Injectable Drugs·5,000 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903,...
Injectable Drugs·5,832 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, ...
Injectable Drugs·684 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, N...
Injectable Drugs·2,779 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 7...
Injectable Drugs·8,946 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, ...
Injectable Drugs·26,928 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY ...
Injectable Drugs·23,136 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, ...
Injectable Drugs·7,548 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL), Rx only, SterRx, 141 Idaho Avenue, Plattsburgh, NY, ...
Injectable Drugs·880 affected·Nov 12, 2021
High RiskFDA
Sterrx, Llc
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903...
Injectable Drugs·1,428 affected·Nov 12, 2021