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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 11,941–11,960 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

B-COMPLEX #3 W/PRES (BENZYL ETOH 2%), B1-100MG, B2-5-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 10ML Vials, MEDAUS PHARMACY

by Medaus, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 13, 2016
Reported by FDA
July 20, 2016
Distribution
U.S. Nationwide, Japan, and New Zealand.

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Drug Recall Terminated Historical recordClass II

B-COMPLEX #3 (PF), B1-100MG, B2-2-PO4-2MG, B3-100MG, B5-2MG, B6-2MG/ML, 2ML Vials, MEDAUS PHARMACY

by Medaus, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
May 13, 2016
Reported by FDA
July 20, 2016
Distribution
U.S. Nationwide, Japan, and New Zealand.

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Drug Recall Terminated Historical recordClass II

TESTOSTERONE CYPIONATE 200mg/ml, 1ML MDV, Vital Care Compounder, Hattiesburg, MS

by Vital Care Compounder, LLC

Reason
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.
Recall initiated
June 29, 2016
Reported by FDA
July 13, 2016
Distribution
MS

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Drug Recall Ongoing Historical recordClass I

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180

by XTREME Z DISTRIBUTORS INC

Reason
Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.
Recall initiated
July 2, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161

by Cantrell Drug Company

Reason
Subpotent Drug
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721

by Cantrell Drug Company

Reason
Subpotent Drug
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455

by Cantrell Drug Company

Reason
Subpotent Drug
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992033

by Cantrell Drug Company

Reason
Subpotent Drug
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

HEPARIN Sodium in 0.45% Sodium Chloride, 1 USP Unit/2 mL (0.5 USP Units/mL), Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-148-16, UPC: 0100352533148163

by Cantrell Drug Company

Reason
Stability Data Does Not Support Expiry
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212

by Cantrell Drug Company

Reason
Stability Data Does Not Support Expiry
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165

by Cantrell Drug Company

Reason
Subpotent Drug
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993491

by Cantrell Drug Company

Reason
Subpotent Drug
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

fentaNYL citrate in 0.9% Sodium Chloride Injection, 5 mcg/1 mL (5 mcg/mL), in a) 1 mL syringe (NDC 52533-214-45, UPC: 0100352533214455) and b) 3 mL syringe (NDC 52533-214-60, UPC: 0100352533214608), Rx Only, Cantrell Drug Co., Little Rock, AR

by Cantrell Drug Company

Reason
Subpotent Drug
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

fentaNYL CITRATE 25 mcg/mL in 5% DEXTROSE Injection, in 2 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock AR --- UPC: 9999993301

by Cantrell Drug Company

Reason
Subpotent Drug
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992131

by Cantrell Drug Company

Reason
Subpotent Drug
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Atropine Sulfate Injection Solution, 0.4 mg/1 mL (0.4 mg/mL), in a) 1 mL syringes and b) 2 mL syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-010-45, UPC: 0100352533010453

by Cantrell Drug Company

Reason
Subpotent Drug
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450

by Cantrell Drug Company

Reason
Subpotent Drug
Recall initiated
August 21, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles

by Bee Extremely Amazed LLC

Reason
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.
Recall initiated
December 15, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health

by Bee Extremely Amazed LLC

Reason
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Recall initiated
December 15, 2015
Reported by FDA
July 13, 2016
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health

by Bee Extremely Amazed LLC

Reason
Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared fluoxetine, an FDA approved drug used to treat depression, anxiety, panic attacks, obsessive-compulsive disorder, or bulimia and phenolphthalein, an ingredient found in over-the-counter laxative products that was withdrawn from the US market due to concerns of carcinogenicity, making it an unapproved drug.
Recall initiated
December 15, 2015
Reported by FDA
July 13, 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.