FDA Drug Recalls

635 recalls, newest first

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

Apr 20, 2016 Class II · Moderate risk

Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0735-03 D-1295-2016

Apr 20, 2016 Class II · Moderate risk

Ketamine 100mg/mL 1mL fill 3 mL syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0709-78 D-1294-2016

Apr 20, 2016 Class II · Moderate risk

HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0702-68 D-1293-2016

Apr 20, 2016 Class II · Moderate risk

Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in…

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0684-68 D-1292-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a…

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0683-68 D-1291-2016

Apr 20, 2016 Class II · Moderate risk

Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0674-80 D-1290-2016

Apr 20, 2016 Class II · Moderate risk

Cefazolin 2GM added to 5% Dextrose 50 mL USP

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0610-41 D-1289-2016

Apr 20, 2016 Class II · Moderate risk

Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0608-75 D-1288-2016

Apr 20, 2016 Class II · Moderate risk

Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0603-78 D-1287-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0521-67 D-1286-2016

Apr 20, 2016 Class II · Moderate risk

Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0505-41 D-1285-2016

Apr 20, 2016 Class II · Moderate risk

Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette

Lack of Assurance of Sterility

Terminated Sterility / contamination Pharmakon Pharmaceuticals, Inc. NDC 45183-0504-41 D-1284-2016

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