FDA Drug Recalls

6,161 recalls · Class II, newest first

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 5183-0906-48 D-1320-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0905-48 D-1319-2016

Apr 20, 2016 Class II · Moderate risk

Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0885-02 D-1318-2016

Apr 20, 2016 Class II · Moderate risk

Morphine Sulfate

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0877-41 D-1317-2016

Apr 20, 2016 Class II · Moderate risk

Morphine Sulfate 1mg/mL

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0876-41 D-1316-2016

Apr 20, 2016 Class II · Moderate risk

Morphine Sulfate 1 mg/mL in 5% Dextrose

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0875-02 D-1315-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 10 mcg/mL

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0869-48 D-1314-2016

Apr 20, 2016 Class II · Moderate risk

Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0867-71 D-1313-2016

Apr 20, 2016 Class II · Moderate risk

Hydromorphone HCI 1 mg/mL in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0865-41 D-1312-2016

Apr 20, 2016 Class II · Moderate risk

Norepinephrine Bitartrate 4 mg

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0855-02 D-1311-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0827-77 D-1310-2016

Apr 20, 2016 Class II · Moderate risk

Diltiazem HCI 250 mg in 5% Dextrose

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0853-02 D-1309-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0826-77 D-1308-2016

Apr 20, 2016 Class II · Moderate risk

Morphine Sulfate

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0823-75 D-1307-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0819-02 D-1306-2016

Apr 20, 2016 Class II · Moderate risk

HYDROmorphone HCI 0.4mg/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 45183-0815-67 D-1305-2016

Apr 20, 2016 Class II · Moderate risk

HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0813-68 D-1304-2016

Apr 20, 2016 Class II · Moderate risk

Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0806-02 D-1303-2016

Apr 20, 2016 Class II · Moderate risk

Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0803-41 D-1302-2016

Apr 20, 2016 Class II · Moderate risk

Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0800-72 D-1301-2016

Apr 20, 2016 Class II · Moderate risk

Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0796-48 D-1300-2016

Apr 20, 2016 Class II · Moderate risk

Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0769-04 D-1299-2016

Apr 20, 2016 Class II · Moderate risk

Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0766-03 D-1298-2016

Apr 20, 2016 Class II · Moderate risk

Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0764-03 D-1297-2016

Apr 20, 2016 Class II · Moderate risk

Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0740-04 D-1296-2016

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