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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 12,081–12,100 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

ESTRADIOL VALERATE 20MG/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

ATROPINE SULFATE 0.5% Ophthalmic Drops, packaged in 5mL 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

CHLORHEXIDINE GLUCO. 0.12% ORAL RINSE, Packaged in 473 ML Bottles, Rx Only. MFG: HI-TECH PHARMACAL CO., INC., AMITYVILLE, NY 11701, Packaged By: Aidarex PHARMACEUTICALS. NDC: 33261-0447-01.

by Aidarex Pharmaceuticals LLC

Reason
Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.
Recall initiated
June 1, 2016
Reported by FDA
June 15, 2016
Distribution
U.S. including: CA, ND, PA, TN

View recall →

Drug Recall Terminated Historical recordClass I

TruTrim (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

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Drug Recall Terminated Historical recordClass I

Thin and Slim Burn Fat Now Dietary Supplement packaged in 90 capsule containers. http://www.secretsofherbs.com. Made in the USA.

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

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Drug Recall Terminated Historical recordClass I

FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bottle WWW.FUELUPPILLS.COM

by Reesna, Inc

Reason
Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.
Recall initiated
December 11, 2015
Reported by FDA
June 15, 2016
Distribution
Nationwide and United Kingdom

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Drug Recall Terminated Historical recordClass II

ITRACONAZOLE 0.2%/MUPIROCIN 0.2%/TRIAMCINOLONE 0.03% NASAL SPRAY, 15mL bottle, 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

ITRACONAZOLE 0.2%/MUPIROCIN 0.2% NASAL SPRAY; 30 mL Spray, 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

CLOTRIMAZOLE 1%/ BETAMETHASONE DIPROPIONATE 0.05% OTIC SOLUTION, 15mL dropper, 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

QUAD-MIX #3, 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

VITAMIN B COMPLEX # 3, 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

VITAMIN B COMPLEX # 1; 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

VANCOMYCIN 50MG/ML OPHTH SOLUTION; packaged in 10mL vial, 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

TRI-MIX # 6, 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

TRI-MIX # 4, 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

TRI-MIX # 3, 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

TRI-MIX # 2, 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

TRI-MIX # 1, 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

TESTOSTERONE CYPIONATE 200MG/ML, packaged in 5mL vials, Rx only, Well Care Compounding Pharmacy Las Vegas, NV

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

TESTOSTERONE CYPIONATE 175MG/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 →

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.