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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 12,501–12,520 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Lidocaine HCI (PF) Inj, USP 2%, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Subpotent drug.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Subpotent drug.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

by Pharmakon Pharmaceuticals

Reason
Stability data does not support expiry.
Recall initiated
August 19, 2015
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HBr 5 mg/5 mL), packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) Sunmark, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: McKesson, San Francisco, CA 94104, NDC 49348-828-34; b) Rite-Aid, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Rite-Aid, Camp Hill, PA 17011, NDC 11822-0419-1; c) Topcare, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: Topco Associates LLC, Elk Grove Village, IL 60007, NDC 36800-419-26; d) Kroger, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: The Kroger Co., Cincinnati, OH 46202, NDC 30142-419-26; e) GoodSense, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Gluten Free, Distributed by: Perrigo, Allegan, MI 49010, NDC 0113-0419-26; f) Dollar General, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Alcohol Free, Distributed by: DolgenCorp, LLC, Goodlettsville, TN 37072, NDC 55910-419-26; g) Care One, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Gluten Free, Distributed by: American Sales Company, Lancaster, NY 14086, NDC 41520-419-26; h) CVS, Children's Mucus Relief Cough, Guaifenesin 100 mg/Expectorant, Dextromethorphan HBr 5 mg/Cough Suppressant, Cherry Flavor, 4 FL OZ (118 mL) Bottle, Distributed by: CVS Pharmacy Inc, Woonsocket, RI 02895.

by Perrigo Company PLC

Reason
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Recall initiated
January 8, 2016
Reported by FDA
February 3, 2016
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.