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 12,121–12,140 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

LEVOCARNITINE 100MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

Hydrogen Peroxide 3%, packaged in 10mL bottles, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

HCG/METHYLCOBALAMIN/FOLIC ACID,1000IU/5MG/0.4MG/ML; packaged in 5 mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

1-HCG 2000 IU/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

1-HCG 1000 IU/ML, packaged in 5mL and 10mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

GLUTATHIONE 200MG/ML, packaged in 5mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

GLUTATHIONE 100MG/ML, packaged in 10 mL vials, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

ESTRADIOL VALERATE 40MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

ESTRADIOL VALERATE 10MG/ML, packaged in 1mL and 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

ESTRADIOL CYPIONATE 10 MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

ALPHA LIPOIC ACID 25MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

17-0H PROGESTERONE 250MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121

by Well Care Compounding Pharmacy

Reason
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.
Recall initiated
May 17, 2016
Reported by FDA
June 15, 2016
Distribution
NV

View recall →

Drug Recall Terminated Historical recordClass II

Coppertone SUNSCREEN LOTION, CLEARLY SHEER, BROAD SPECTRUM SPF 50, 5 FL OZ (147mL), OTC, Dist by: Bayer HealthCare LLC, Whippany, NJ 07981 --- NDC 11523-7391-1, UPC 00041100005762

by Bayer Health Care LLC

Reason
Labeling; Product Contains Undeclared API (Oxybenzone)
Recall initiated
May 10, 2016
Reported by FDA
June 15, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Potassium CHLORide added to 5% Dextrose Injection, 20 mEq 250 mL Bag, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-836-11, Service Code 2K5836.

by PharMEDium Services, LLC

Reason
Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.
Recall initiated
May 16, 2016
Reported by FDA
June 15, 2016
Distribution
NY

View recall →

Drug Recall Terminated Historical recordClass III

CEFTRIAXONE for Injection USP, 250mg/vial, Rx only, MFG: LUPIN LIMITED INDIA, Packaged by Aidarex Pharmaceuticals, NDC 53217-0117-01

by Aidarex Pharmaceuticals LLC

Reason
CGMP Deviations: Out of specification (OOS) intermediate in the subsequent processes to manufacture the final API.
Recall initiated
June 1, 2016
Reported by FDA
June 15, 2016
Distribution
IN, GA

View recall →

Drug Recall Terminated Historical recordClass I

Xcellerator (product not labeled)

by Novacare, LLC

Reason
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Recall initiated
August 24, 2015
Reported by FDA
June 15, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Methyldrene Original 25 Ephedra ECA Stack Extra-Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.

by Novacare, LLC

Reason
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Recall initiated
August 24, 2015
Reported by FDA
June 15, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Black Widow 25 Ephedra Super Potent Fat Burner Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.

by Novacare, LLC

Reason
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Recall initiated
August 24, 2015
Reported by FDA
June 15, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Asia Black 25 Ephedra Extreme Fat Burner Potent Dietary Supplement packaged in 100 capsule containers. Distributed by Cloma Pharma Laboratories, Samford, CT 06902.

by Novacare, LLC

Reason
Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.
Recall initiated
August 24, 2015
Reported by FDA
June 15, 2016
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.