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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 11,821–11,840 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75

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

Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0603-78

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

Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0521-67

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

Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41

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

Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0504-41

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

Morphine Sulfate 1mg/mL in 0.9% Sodium Chloride 50 mL fill in a 50 mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0502-41

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

Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0407-03

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

Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78

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

Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0223-48

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

Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0216-48

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

HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0190-78

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

Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0189-02

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

Promethazine 25 mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx, Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0187-41

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

Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0186-41

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

Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72

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

Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41

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

Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0174-02

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

Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0173-02

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

Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0171-01

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 100 mL Intravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0148-48

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 →

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.