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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 13,461–13,480 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Fentanyl 2,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl 1,000 mcg/ml + Bupivacaine 25 mg/ml Baclofen 500 mcg/ml + Clonidine 500 mcg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl 1,000 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl 3,000 mcg/ml + Bupivacaine 20 mg/ml Intrathecal Solution, Sterile - Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 8 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 6 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 3 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dexpanthenol 250 mg/ml Injectable, ml Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Dexpanthenol 215 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Cyanocobalamin 1,000 mcg/ml + B-Complex 500 mg/ml, ml, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Cyanocobalamin 1,000 mcg/ml, Multi-Dose vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Copper (Cupric)Sulfate 2 mg/ml Injectable, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

by The Compounding Pharmacy of America

Reason
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recall initiated
June 2, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

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.