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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 13,401–13,420 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Morphine 45 mg/ml + Bupivacaine 40 mg/ml 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

Morphine 45 mg/ml 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

Morphine 40 mg/ml + Clonidine 500 mcg/ml 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

Morphine 40 mg/ml + Bupivacaine 16 mg/ml 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

Morphine 35 mg/ml 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

Morphine 33 mg/ml 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

Morphine 30 mg/ml + Clonidine 250 mcg/ml 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

Morphine 30 mg/ml + Bupivacaine 5 mg/ml 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

Morphine 30 mg/ml + Baclofen 10 mcg/ml 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

Morphine 25 mg/ml 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

Morphine 20 mg/ml + Clonidine 400 mcg/ml 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

Morphine 15 mg/ml 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

Mitomycin 40 mg/50 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, 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

Mitomycin 40 mg/40 ml Sodium Chloride 0.9% Injection, Single Dose Syringe, 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

MIC-B12+B6 Injection, 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

MIC-B COMPLEX Injectable, 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

MIC+Methylcobalamin 4000 mcg/ml Injection, 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

Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml Injection, 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

Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable, Sterile-Multi-Dose Vial,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

Methylcobalamin 5,000 mcg/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.