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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 13,381–13,400 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Sodium Ascorbate 500 mg/ml Injection, Preservative Free 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

Sermorelin 300 mcg/ml + GHRP-2 300 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, 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

Sermorelin 1000mcg/GHRP6 1000/GHRP2 1000 ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, 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

Sermorelin/GHRP6 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, 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

Sermorelin/GHRP2 1000/1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, 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

Sermorelin 1000 mcg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, DO NOT SHAKE, 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

Polidocanol 1% 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

Phosphatidylcholine 0.1% Sodium Deoxycholate 0.089% Injection, 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

PGE 80 (Alprostadil) 80 mcg/ml Injection, Multi-Dose Vial, Sterile, Keep Frozen, 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

PGE 150 (Alprostadil) 150 mcg/ml, ml, Multi-Dose Vial, Sterile, Keep Frozen, 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

Oxytocin 100 units/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

Neomycin + Polymyxin B+ Bacitracin Ophthalmic Ointment, grams, 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

Nandrolone Decanoate 250 mg/ml Injection, 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

Nandrolone Decanoate 200 mg/ml Injection, 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

Morphine 70 mg/ml + Clonidine 1,100 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 70 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 50 mg/ml +Fentanyl 1,000 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 50 mg/ml + Clonidine 200 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 50 mg/ml + Clonidine 100 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 50 mg/ml + Bupivacaine 2.5 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 →

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.