FDA Drug Recalls

6,161 recalls · Class II, newest first

May 13, 2016 Class II · Moderate risk

B-Complex #3

Lack of Assurance of Sterility

Terminated Sterility / contamination Medaus, Inc. D-1167-2016

Apr 27, 2016 Class II · Moderate risk

Linezolid Injection

Lack of Assurance of Sterility: Due to potential for leaking bags.

Terminated Sterility / contamination Teva North America NDC 0703-9060-31 D-0868-2016

Apr 20, 2016 Class II · Moderate risk

Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium…

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0996-02 D-1344-2016

Apr 20, 2016 Class II · Moderate risk

Bupivacaine HCI 0.25% in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0994-03 D-1343-2016

Apr 20, 2016 Class II · Moderate risk

Midazolam HCl 1mg/mL in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0989-41 D-1341-2016

Apr 20, 2016 Class II · Moderate risk

Vecuronium 1mg/mL in Sterile Water

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0972-72 D-1340-2016

Apr 20, 2016 Class II · Moderate risk

Rocuronium 10mg/ml 10ml fill in a 10ml BD syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0971-72 D-1339-2016

Apr 20, 2016 Class II · Moderate risk

Midazolam HCI 1mg/mL in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0966-69 D-1338-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 50 mcg/mL

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0964-70 D-1337-2016

Apr 20, 2016 Class II · Moderate risk

Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0961-72 D-1336-2016

Apr 20, 2016 Class II · Moderate risk

Cefazolin 1GM in Sterile Water

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0960-72 D-1335-2016

Apr 20, 2016 Class II · Moderate risk

Ondansetron 2mg/mL

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0957-69 D-1334-2016

Apr 20, 2016 Class II · Moderate risk

Rocuronium 10 mg/mL

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0955-70 D-1333-2016

Apr 20, 2016 Class II · Moderate risk

Lidocaine 2%

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0946-70 D-1332-2016

Apr 20, 2016 Class II · Moderate risk

Ropivacaine HCI 0.2% in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0942-03 D-1331-2016

Apr 20, 2016 Class II · Moderate risk

Ephedrine Sulfate 5 mg/ml in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0939-70 D-1330-2016

Apr 20, 2016 Class II · Moderate risk

Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL…

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0938-68 D-1329-2016

Apr 20, 2016 Class II · Moderate risk

Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0935-67 D-1328-2016

Apr 20, 2016 Class II · Moderate risk

Phenylephrine HCI

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0934-70 D-1327-2016

Apr 20, 2016 Class II · Moderate risk

HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0933-75 D-1326-2016

Apr 20, 2016 Class II · Moderate risk

HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a…

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0932-68 D-1325-2016

Apr 20, 2016 Class II · Moderate risk

Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0927-72 D-1324-2016

Apr 20, 2016 Class II · Moderate risk

Ketamine 20 mg/mL in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0925-41 D-1323-2016

Apr 20, 2016 Class II · Moderate risk

Succinylcholine Chloride 20 mg/mL

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0920-72 D-1322-2016

Apr 20, 2016 Class II · Moderate risk

Bupivacaine HCI 0.125% in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0909-02 D-1321-2016

Recalls by year

2026563
2025778
2024557
20231,122
20221,390
20211,152
2020930
20191,788
20181,681
20171,141
20161,199
20151,733
20141,309
20132,085
2012534
201134
20104
20072
20061