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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 13,281–13,300 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Estradiol 15 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

DMPS (Sodium 2, 3 Dimercaptopropane Sulfonate) 50 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 100 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 10 mg Pellet, 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

Collagenase 250 units/ml, 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

Bupivacaine 15 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

Bupivacaine 40 mg/ml +Baclofen 130 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

Brompheniramine Maleate 20 mg/ml Injectable, 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

Baclofen 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

Ascorbic Acid 500 mg/ml Injectable Vial, 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

Alprostadil 50 mcg/ml Injection, 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

Alprostadil 40 mcg/ml Injection, 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

Alprostadil 100 mcg/ml Injection, 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

5-Methyl Tetrahydrofolate (5-MTHF) 1 mg/ml Injectable, Sterile-Multi-Dose Vial, 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 III

IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02, UPC 3 17478-701-02 6) containing 6-count IC-Green Vials 25 mg (NDC 17478-701-25, barcode (01)00317478701255) and 6-count 10 mL Sterile Aqueous Solvent Ampules (NDC 17478-701-10, UPC 3 17478-701-10 1) per carton, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

by Akorn, Inc.

Reason
Subpotent Drug: Low out-of-specification potency result of the drug product.
Recall initiated
April 20, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05

by Hospira Inc.

Reason
Defective Container: There were customer complaints of cracked and leaking glass vials.
Recall initiated
August 20, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Cevimeline Hydrochloride Capsules, 30 mg a) 100 count bottle, and b) 500 count bottle, Rx Only, Manufactured by: Apotex Research Pvt., Ltd., Bangalore, India, Manufactured for: Apotex Corp, Westin, FL, a) NDC 60505-3145-1, b) NDC 60505-3145-5

by Apotex Inc.

Reason
Failed Stability Specifications: product may not meet specification limit for assay test.
Recall initiated
August 17, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

ClomiPHENE CITRATE Tablets, USP, 50 mg, 10-count (2 foil sealed plastic trays of 5 tablets each) per carton, Rx only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD., Jerusalem, 91010, Israel; Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; NDC 0093-0041-03, UPC 3 0093-0041-03 7.

by EMD Serono, Inc.

Reason
Chemical Contamination: impurity failure due to chemical contamination of the active ingredient.
Recall initiated
September 10, 2015
Reported by FDA
September 23, 2015
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Tri-Mix T-50/PGE 1 0.14/0.08 Injectable, 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

Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable, 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.