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 8,261–8,280 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Homeopathic Heart Regularity, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955506522, NDC 57955-5065-2

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Homeopathic Regional Allergies Northeastern U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955519225, NDC 57955-0753-2

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass II

Little Remedies New Baby Essentials Kit. Each kit contains 1 each of the following products: Little Remedies Infant Fever Reducer (acetaminophen 150mg) 2 fl. oz. bottle, Little Remedies Saline Spray/Drops (sodium chloride) 0.5 fl oz., Little Remedies Gripe Water (zingiber officinale (Ginger) Root Extract 5mg, Foeniculum vulgare (Fennel) Seed Extract 4 mg) 2 fl. oz bottle., Little Remedies Gas Relief Drops (simethicone emulsion USP 66.7 mg and simethicone 20 mg) 1 fl. oz., Boudreaux's Butt Paste (zinc oxide 16%) 2 oz. ointment,. Distributed by Medtech Products Inc. Tarrytown, NY, a Prestige Consumer Healthcare Company. UPC 7 56184 00007 6.

by Medtech Products, Inc.

Reason
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Recall initiated
March 7, 2019
Reported by FDA
March 20, 2019
Distribution
Nationwide in the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07

by Macleods Pharma Usa Inc

Reason
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Recall initiated
February 25, 2019
Reported by FDA
March 20, 2019
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass II

Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875

by Roberts Home Medical LLC

Reason
CGMP Deviations
Recall initiated
December 19, 2018
Reported by FDA
March 20, 2019
Distribution
Product was distributed in MD, VA and the District of Columbia

View recall →

Drug Recall Terminated Historical recordClass II

Gentamicin Sulfate Ophthalmic Solution, USP, 0.3%, 5 mL bottle, Rx only, Manufactured for: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-283-10.

by Akorn, Inc.

Reason
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Recall initiated
February 22, 2019
Reported by FDA
March 20, 2019
Distribution
Nationwide USA and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.

by Boehringer Ingelheim Pharmaceuticals, Inc.

Reason
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Recall initiated
March 7, 2019
Reported by FDA
March 20, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Leg Cramp & Spasm Relief Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955543527, NDC 57955-6035-2

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Bug Away Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955507726, NDC 57955-5077-2

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's SafeCareRx CS-Lung High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955022626, NDC 57955-0226-2

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Kids Aquaflora Candida Multi-Strain Formula, 118 mL (liquid), Manufactured by: King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80074869 UPC 357955181941

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's Advanced Arnica Super Arnica, 59 mL, Manufactured by: King Bio, Inc. 3 Westside Dr. Asheville, NC 28806 Imported by Ambiental Solutions, Inc. Vancouver, BC, V5Y 1E6, DIN-HM 800774304 UPC 357955181330

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's SafeCare Rx Hyperactive High Potency Homeopathic Formula, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955151029, NDC 57955-1511-2

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's Appetite Enhancer Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955512820

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Regional Allergies Western Canada, 59 mL, (liquid/liquide), DIN-HM 80074875 UPC 357955181828

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Respiratory Care, 59 mL, (liquid/liquide), DIN-HM 80035323 UPC 357955180623

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Multi-Strain Flu Relief, 59 mL, (liquid/liquid), DIN-HM 80038065 UPC 357955180128

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Regional Allergies Eastern Canada, 59 mL, (liquid/liquide) DIN-HM 80075212 UPC 357955181620

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Anxiety & Nervousness, 59 mL, (liquid/liquide), DIN-HM 80074778 UPC 357955181521

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

View recall →

Drug Recall Terminated Historical recordClass I

NET Remedies #25 Yin/Yang Balance Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4215-2

by King Bio Inc.

Reason
Microbial contamination
Recall initiated
July 20, 2018
Reported by FDA
March 20, 2019
Distribution
U.S.A. Nationwide, Canada, and Australia.

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.