Skip to main content
Get Alerts

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.

Filters
Recall details
Location
Date range
Clear filters

Showing 10,121–10,140 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Medline Suture Removal 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 TRAY, CATHETER CARE, LIDDED. 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 Trunk Kit, Non-sterile. 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 CNTRL Line Removal Kit Scripps. 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 Pediatric IV Kit. 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 Concordia Nurse Bag Kit. 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 Concordia Trunk Kit. Packaged 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 Newborn Kit. Packaged 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 RAD NECK ENT TRAY Pack, 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 Vitrectomy CDS Pack, 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

Medline Vaginal Delivery CDS Pack, 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

Medline CC Drawer 4 IV Circulation Pack, Contains Rx, Single Use Only, contains 2 Prep Pad PVPs. 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

Aplicare Povidone-Iodine Prep Pad, Antiseptic, Sterile Solution, Active Ingredient: Povidone-iodine USP 10%. Aplicare, INC., Meriden, CT 06450 USA. NDC: 52380-0111-1

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

Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.

by Premier Pharmacy Labs Inc

Reason
Labeling: Label Error on Declared Strength
Recall initiated
January 11, 2018
Reported by FDA
February 7, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Failed Content Uniformity Specifications
Recall initiated
December 21, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01

by Ascent Pharmaceuticals, Inc.

Reason
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Recall initiated
January 22, 2018
Reported by FDA
February 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5

by Blue Fusion Natural

Reason
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Recall initiated
November 29, 2017
Reported by FDA
February 7, 2018
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205

by JCB Laboratories LLC

Reason
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Recall initiated
January 24, 2018
Reported by FDA
February 7, 2018
Distribution
Nationwide within USA

View recall →

Drug Recall Terminated Historical recordClass II

Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866

by Johnson & Johnson

Reason
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Recall initiated
December 7, 2017
Reported by FDA
February 7, 2018
Distribution
Product was distributed nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can, NET WT. 5 OZ. (141 g) Distributed By: Johnson & Johnson Consumer Inc. Skillman, NJ 08558. UPC: 0 70501 10053 0

by Johnson & Johnson

Reason
Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Recall initiated
December 7, 2017
Reported by FDA
February 7, 2018
Distribution
Product was distributed 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.