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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 8,941–8,960 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass I

Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59

by Silver Star Brands

Reason
Microbial Contamination of Non-Sterile Products
Recall initiated
October 3, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone 200 mg/Anastrozole 20 mg pellet, 1 count (NDC 69761-222-01), 6 count (NDC 69761-222-06), 12 count (NDC 69761-222-12), and 30 count (NDC 69761-222-30) vials, Rx Only, Qualgen, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone 50mg pellet, 1 count (NDC 69761-150-01), 6 count (NDC 69761-150-06), 12 count (NDC 69761-150-12), and 30 count (NDC 69761-150-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone 25 mg pellet, 1 count (NDC: 69761-125-01) and 30 count vials (NDC: 69761-125-30), Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 15mg pellet, 1 count (NDC 69761-015-01), 6 count (NDC 69761-015-06), 12 count (NDC 69761-015-12), and 30 count (NDC 69761-015-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Estradiol 12.5mg pellet, 1 count (NDC 69761-012-01), 6 count (NDC 69761-012-06), 12 count (NDC 69761-012-12), and 30 count (NDC 69761-012-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013

by Qualgen, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 17, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Metoprolol Tartrate Injection, USP, 5 mg/ 5 mL (1 mg/mL), 5 mL per sterile single use glass vial, Rx Only, Manufactured for: Claris Lifesciences, Inc., North Brunswick, NJ 08902. By: Claris Injectables Ltd., Gujarat, India. NDC: 36000-033-10

by Baxter Healthcare Corporation

Reason
Failed pH Specifications: Upward shift in the pH of the solution within the shelf life of the impacted lots.
Recall initiated
October 15, 2018
Reported by FDA
November 14, 2018
Distribution
Distributed nationwide in the USA and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Alcohol Free Foaming Hand Sanitizer (benzalkonium chloride), 0.13%, 1 L (33.8 fl. oz.) cartridge packaged in 8 cartridges per case, Safe-T-Fresh Inc., USA, 2530 Xenium Lane North, Minneapolis, MN 55441.

by S.C. Johnson Professional

Reason
CGMP Deviations: Product was released to market prior to microbiological testing.
Recall initiated
October 26, 2018
Reported by FDA
November 14, 2018
Distribution
NC

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Drug Recall Terminated Historical recordClass II

Ortho-Novum 1/35 (norethindrone/ethinyl estradiol) Tablets, 1 mg/0.035 mg, 28-Day Regimen per pouch (NDC 50458-176-28), 6 Veridate Tablet Dispensers and 6 refills per carton (NDC 50458-176-06), Rx only, Manufactured by: Janssen Ortho, LLC, Manati, Puerto Rico 00674; Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, New Jersey 08560.

by Janssen Pharmaceuticals, Inc.

Reason
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Recall initiated
October 23, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

0.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0409-7983-61; c) 50 mL NDC 0409-7984-36; d) 100 mL NDC 0409-7984-37, Hospira, Inc. Lake Forest, IL 60045

by ICU Medical Inc

Reason
Lack of Assurance of Sterility; bags have the potential to leak
Recall initiated
October 8, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20; b) 250 mL NDC 0409-7922-02, Hospira, Inc. Lake Forest, IL 60045

by ICU Medical Inc

Reason
Lack of Assurance of Sterility; bags have the potential to leak
Recall initiated
October 8, 2018
Reported by FDA
November 14, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1745-30

by Pharm D Solutions, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 10, 2018
Reported by FDA
November 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30 mL Injectable, Pharm D Solutions, Houston, Texas NDC 69699-1702-05

by Pharm D Solutions, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 10, 2018
Reported by FDA
November 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1418-10

by Pharm D Solutions, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 10, 2018
Reported by FDA
November 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- NDC 69699-1407-25

by Pharm D Solutions, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 10, 2018
Reported by FDA
November 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05

by Pharm D Solutions, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 10, 2018
Reported by FDA
November 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-1351-05

by Pharm D Solutions, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 10, 2018
Reported by FDA
November 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1339-05

by Pharm D Solutions, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 10, 2018
Reported by FDA
November 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolamine 0.59 mcg per mL Pharm D Solutions, Houston, Texas --- NDC 69699-1366-05

by Pharm D Solutions, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
September 10, 2018
Reported by FDA
November 7, 2018
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.