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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 12,221–12,240 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

Real Skill, packaged in 20 small boxes / 4 capsules per box / 80 capsules total, Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

by R Thomas Marketing, LLC

Reason
Marketed Without An Approved NDA/ANDA
Recall initiated
January 9, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide via Internet sales

View recall →

Drug Recall Terminated Historical recordClass I

Herb Viagra, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

by R Thomas Marketing, LLC

Reason
Marketed Without An Approved NDA/ANDA
Recall initiated
January 9, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide via Internet sales

View recall →

Drug Recall Terminated Historical recordClass I

Black Ant, packaged in Big Box (20 small boxes / 4 capsules per box / 80 capsules total), Distributed by: R Thomas Marketing, LLC, Bronx, NY 10467

by R Thomas Marketing, LLC

Reason
Marketed Without An Approved NDA/ANDA
Recall initiated
January 9, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide via Internet sales

View recall →

Drug Recall Terminated Historical recordClass I

Shorts on the Beach capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010

by Lucy's Weight Loss (dba. Waisted With Lucy)

Reason
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
Recall initiated
December 9, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Pink Bikini capsules, (all colors and all strengths), packaged in 30-count bottle, Manufactured and Distributed by: Lucy's Weight Loss System (dba Waisted With Lucy), Arlington, TX 76010

by Lucy's Weight Loss (dba. Waisted With Lucy)

Reason
Marketed without an approved NDA/ANDA: Product contains undeclared Sibutramine, Phenolphthalein and/or Diclofenac.
Recall initiated
December 9, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Shorts on The Beach Golden Edition by Pink Bikini, 800 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010

by Lucy's Weight Loss (dba. Waisted With Lucy)

Reason
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Recall initiated
September 23, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Shorts on The Beach Strong Formula by Pink Bikini capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010

by Lucy's Weight Loss (dba. Waisted With Lucy)

Reason
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Recall initiated
September 23, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Pink Bikini Strong Formula capsules, 750 mg, packaged in 30-count plastic bottle, Manufactured and Distributed by: Lucy's Weight Loss System, Arlington, Texas 76010

by Lucy's Weight Loss (dba. Waisted With Lucy)

Reason
Marketed without an approved NDA/ANDA: Product contains undeclared sibutramine and phenolphthalein.
Recall initiated
September 23, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Smart Lipo Dietary Supplement capsules, 900 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011

by Centro Naturista

Reason
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Recall initiated
June 3, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Smart Lipo Dietary Supplement capsules, 800 mg, packaged in 30-count plastic bottle, Distributed by: SmartLipo365, Arlington, TX 76011

by Centro Naturista

Reason
Marketed without an approved NDA/ANDA - Product contains undeclared sibutramine, desmethylsibutramine and phenolphthalein.
Recall initiated
June 3, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

PerioRx (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for Discus Dental, LLC, Ontario, CA 91761, UPC 4235 020 91701

by Akorn, Inc.

Reason
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Recall initiated
March 23, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Chlorhexidine gluconate, oral rinse, 0.12% packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured by HI-TECH PHARMACAL CO., INC., Amityville, NY 11701, NDC 5083-0720-16

by Akorn, Inc.

Reason
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Recall initiated
March 23, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

ORIS (chlorhexidine gluconate), oral rinse, 0.12%, packaged in 16 fl. oz. (473 mL) PET bottle, Rx only, Manufactured for DENTSPLY Professional, York, PA 17404, UPC D00513003001O

by Akorn, Inc.

Reason
Failed impurities/degradation specifications: Out-of-specification result (for multiple batches) for an unknown impurity of Chlorhexidine gluconate.
Recall initiated
March 23, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company

by Sanofi-Aventis U.S. LLC

Reason
Defective Delivery System; potential to have inaccurate dosage delivery
Recall initiated
October 28, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company

by Sanofi-Aventis U.S. LLC

Reason
Defective Delivery System; potential to have inaccurate dosage delivery
Recall initiated
October 28, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Morphine Sulfate 0.5 mg/mL, Preservative Free in 0.9% Sodium Chloride, Rx, total volume 1 mL, This is a compounded drug, CII, IV Use, syringe, Pharmakon Pharmaceuticals, NDC 45183-0322-78.

by Pharmakon Pharmaceuticals

Reason
Super-Potent Drug: Out of specification for potency results (high) were obtained for one lot of morphine sulfate Inj.
Recall initiated
February 11, 2016
Reported by FDA
June 1, 2016
Distribution
IN and IL

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Drug Recall Terminated Historical recordClass I

Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.

by Pacifico National, Inc. dba AmEx Pharmacy

Reason
Non-Sterility: Product tested positive for bacterial contamination.
Recall initiated
January 20, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx Pharmacy, 1515 Elizabeth St Suite J, Melbourne, FL 32901.

by Pacifico National, Inc. dba AmEx Pharmacy

Reason
Non-Sterility: Product tested positive for bacterial contamination.
Recall initiated
January 20, 2015
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hungary; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454

by Teva North America

Reason
Lack of Assurance of Sterility: Due to potential for leaking bags.
Recall initiated
April 27, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04

by Fresenius Kabi USA, LLC

Reason
Failed Impuities/Degradation Specifications
Recall initiated
May 4, 2016
Reported by FDA
June 1, 2016
Distribution
Nationwide and Puerto Rico.

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.