Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 11,781–11,800 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 5mg/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 45183-0935-67

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

Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70

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 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Monoject Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0933-75

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

HYDROmorphone HCI 1mg/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 45183-0932-68

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

Phenylephrine HCI100mcg/mL in 0.9% sodium Chloride 10ml fill in a 10mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0927-72

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

Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0925-41

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

Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0920-72

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

Bupivacaine HCI 0.125% in 0.9% Sodium Chloride, 250 mL lntravia bag, Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0909-02

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 & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 mL bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 5183-0906-48

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

Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, 150 mL lntravia bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0905-48

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

Vancomycin HCL 1.25 GM added to 5% Dextrose in a 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0885-02

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

Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0877-41

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 (Preserved) in 0.9% Sodium Chloride, 50 mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0876-41

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 1 mg/mL in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0875-02

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 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0869-48

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

Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71

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 1 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag IV USE ONLY, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060 , NDC 45183-0865-41

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 Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0855-02

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 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0827-77

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

Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0853-02

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 →

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.