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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 11,801–11,820 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0826-77

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate (Preserved) 2mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 ml BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0823-75

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate 2mcg/mL & 0.2% Ropivacaine HCI in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0819-02

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0813-68

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0796-48

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0769-04

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0766-03

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0740-04

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0735-03

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Ketamine 100mg/mL 1mL fill 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0709-78

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0702-68

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0684-68

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0683-68

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0674-80

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Drug Recall Terminated Historical recordClass II

Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0610-41

by Pharmakon Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
April 20, 2016
Reported by FDA
July 20, 2016
Distribution
Nationwide VA/DOD: CA, KY, MD, NC, OK, TX, VA

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.