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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 10,061–10,080 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Recall initiated
January 29, 2018
Reported by FDA
February 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Recall initiated
January 29, 2018
Reported by FDA
February 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51

by AbbVie Inc.

Reason
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Recall initiated
January 22, 2018
Reported by FDA
February 7, 2018
Distribution
MS, OH

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Drug Recall Terminated Historical recordClass II

PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60

by PD-Rx Pharmaceuticals, Inc.

Reason
CGMP deviations.
Recall initiated
January 25, 2018
Reported by FDA
February 7, 2018
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: Glenmark Pharmaceuticals Ltd. Village Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 NDC 68462019255 UPC 3684620192559

by Glenmark Pharmaceuticals Inc., USA

Reason
CGMP Deviations: Market complaints related to "gritty texture".
Recall initiated
November 20, 2017
Reported by FDA
February 7, 2018
Distribution
Product was distributed throughout the United States.

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Drug Recall Terminated Historical recordClass II

Medline Incision & Drainage Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

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Drug Recall Terminated Historical recordClass II

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Medline Skin Stapler RMVR, Tray Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Medline Suture Removal Pack Latex Safe, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Professional Hospital Supply Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Professional Hospital Supply, Inc., 41980 Winchester Rd., Temecula, CA 92590

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Medline Incision and Drainage Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Medline Anesthesia Kit, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Northfield, IL 60093

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

View recall →

Drug Recall Terminated Historical recordClass II

Medline Incision Drainage Kit, Sterile, Single Use Only. Packaged in Mexico by Medline Industries, Inc., Mundelein, IL 60060

by Medline Industries Inc

Reason
Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.
Recall initiated
September 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide USA, Puerto Rico, China, Chile, Guam, Honduras, India, Israel, Malaysia, Mexico, Turkey

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.