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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 13,421–13,440 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Methylcobalamin 1,000 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 →

Drug Recall Terminated Historical recordClass II

Methionine 25 mg/ml + Inositol 50 mg/ml + Choline 50 mg/ml 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

Magnesium Sulfate 500 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

Lidocaine 1% Injection, 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

L-Arginine 100 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

Hydroxyprogesterone Caproate (17-HP) 250 mg/ml Injectable, Multi-Dose Vial, 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

Hydroxocobalamin 10 mg/ml Folic Acid 4 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

Hydroxocobalamin 1,000 mcg/ml Injection, 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

Hydromorphone 60 mg/ml + Bupivacaine 30 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

Hydromorphone 40 mg/ml + Bupivacaine 20 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

Hydromorphone 20 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

Hydromorphone 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

Hydromorphone 12.5 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

Hydromorphone 10 mg/ml + Baclofen 2,500 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

Hydromorphone 10 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

Hydromorphone 1 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

Hyaluronidase 150 units/ml Injection, ml, Sterile, Preserved, 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

Hyaluronidase 150 units/ml Injection, ml, Sterile, Preservative Free, 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

HCG 1,200 IU/ml Injection, 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

HCG 4,000 IU/ml Injection, 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.