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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 8,461–8,480 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass I

Dr. King's Lymph Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955506324, NDC 57955-5063-2

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 aquaflora Candida High Potency, 8 fl. oz. (236 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 35795580018, NDC 57955-8020-89

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.

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Drug Recall Terminated Historical recordClass I

Golean DETOX capsules, 14 Net: 56 g, 14 packets containing 2 capsules per packet, 28-count capsules per box, MAT XI S.G Co., LTD, Head office: J29 Vo Thi Sau Street, Thong Nhat Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Manufactory: 148/9 Tan Tien Ward, Bien Hoa City, Dong Nai Province, Viet Nam; Product distribution franshise by GoLean Detox Enterprise 002677155-A Malaysia, www.matxisg.com, UPC 8 938510 909013.

by Golean Detox US

Reason
Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain undeclared sibutramine and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. Phenolphthalein was once an ingredient used in over-the-counter laxatives, but because of concerns of carcinogenicity is not currently approved for marketing in the US. The presence of sibutramine and phenolphthalein in this product renders it an unapproved drug for which the safety and efficacy has not been established and, therefore, subject to recall.
Recall initiated
February 22, 2019
Reported by FDA
March 20, 2019
Distribution
Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07

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

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Drug Recall Terminated Historical recordClass II

Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07

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

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Drug Recall Terminated Historical recordClass II

Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.

by Dr. Reddy's Laboratories, Inc.

Reason
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Recall initiated
March 6, 2019
Reported by FDA
March 20, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

Dr. King's SafeCare Rx Breast Cyst & Discomforts High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955000327, NDC 57955-0003-2

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.

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Drug Recall Terminated Historical recordClass I

Dr. King's SafeCare Rx Aversion to Change High Potency Homeopathic Formula for Professional Use Only, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955280026, NDC 57955-2800-2

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.

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Drug Recall Terminated Historical recordClass I

Dr. King's SafeCare Rx Sinus Relief High Potency Homeopathic Formula, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955013426, NDC 57955-0134-2

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.

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Drug Recall Terminated Historical recordClass I

Dr. King's SafeCare Rx Melancholic Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955201021, NDC 57955-2011-2

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.

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Drug Recall Terminated Historical recordClass I

Dr. King's SafeCare Rx Aller-Detox: Outdoor Pollution Control Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955240426, NDC 57955-2404-2

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.

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Drug Recall Terminated Historical recordClass I

Dr. King's SafeCare Rx Allergies Pacific U.S. Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA, UPC 357955260820, NDC 57955-2717-2

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.

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Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Stress Control, 59 mL, (liquid/liquide), DIN-HM 80041740 UPC 357955180524

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.

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Drug Recall Terminated Historical recordClass I

Dr. King's Natural Medicine Regional Allergies Canadian Prairies, 59 mL (liquid/liquide), DIN-HM 80074815 UPC 357955181729

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 Aquaflora Candida High Potency 9 Multi-Strain Candida Formula, 236 mL, (liquid/liquide), Manufactured by:/Fabrique par: King Bio, Inc. 3 Westside Dr., Asheville, NC 28805 USA Import by: Importe par: Ambiental Solutions Inc. Vancouver, BC, V5Y 1E6, DIN-HM 80036805 UPC 357955180289

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.

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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 800774305 UPC 357955181224

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.

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Drug Recall Terminated Historical recordClass I

NET Remedies #9 ER 911 Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4209-2

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

NET Remedies #8 Allergy (Blue Label) Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4208-2

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

NET Remedies #11 Visceral Polarity Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4211-2

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

NET Remedies #7 Flora Plus Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4207-2

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.