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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 12,141–12,160 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

Thin and Slim Extreme Stack Fat Burner Dietary Supplement packaged in 90 capsule containers. TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com

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

Thin and Slim Naturally The Natural Alternative AM Dietary Supplement packaged in 90 capsule containers. Distributed by TSN Labs Inc., P.O. Box 38, Midvale, UT 84047, 1-800-769-7290, www.tsn2000.com

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

The Store Thin and Slim Thermogenic Fat Burner Dietary Supplement packaged in 90 capsule containers. Distributed by The Store 2050 E. 6200 S., Holladay, UT 84121, The Store Holliday, 4695 S.Holladay Blvd, Holladay, UT 84117, The Store Midway, 42 W. Main Street, Midway, UT 84049.

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

MetaPro 360 Metabolic Accelerator Dietary Supplement packaged in 120 capsule containers. www.metapro360.com 877-778-7509.

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

Thin and Slim MaxOut Body Max Out FX Fat Burner with Ephedra packaged in containers of 60 capsules. Distributed by Teamtrade, Inc., Ft. Lauderdale, FL. 1-866-MaxOut www.MaxOutBODY.com.

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

The People's Chemist Thermo FX Barely Legal Thermogenic Aid, packaged in 90 capsule containers. Manufactured by TPC, LLC, www.thepeopleschemist.com.

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

Thin and Slim Fataway Ultimate Stack with Chromium, packaged per 120 capsules. Distributed by Dale H Enterprises Inc. Lewisburg, PA 17837, www.fataway.org.

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

FUEL UP PLUS, 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 I

Dextrose Injection,USP,70% 2000 mL VIAFLEX Plastic Container Bag, Pharmacy Bulk Package, Not For Direct Infusion, Must Be Diluted, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0719-06

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Recall initiated
December 15, 2015
Reported by FDA
June 15, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02

by Baxter Healthcare Corp.

Reason
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Recall initiated
December 15, 2015
Reported by FDA
June 15, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled Pen, Rx only, Novo Nordisk Inc., Plainsboro, NJ --- NDC 0169-7703-21

by Novo Nordisk Inc

Reason
Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Recall initiated
April 27, 2016
Reported by FDA
June 15, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Recall initiated
March 11, 2016
Reported by FDA
June 8, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recall initiated
March 11, 2016
Reported by FDA
June 8, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recall initiated
March 11, 2016
Reported by FDA
June 8, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recall initiated
March 11, 2016
Reported by FDA
June 8, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Recall initiated
March 11, 2016
Reported by FDA
June 8, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass III

¿Topicort (desoximetasone) Cream USP, 0.05%, Packaged in 5 g Tubes, Professional Sample Only, Rx Only. Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-5205-5.

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Subpotent Drug
Recall initiated
March 31, 2016
Reported by FDA
June 8, 2016
Distribution
U.S. Including: CA, CT, MA, MD, NY, NJ, OK, TX, and WA

View recall →

Drug Recall Terminated Historical recordClass II

Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12

by Akorn, Inc.

Reason
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Recall initiated
May 17, 2016
Reported by FDA
June 8, 2016
Distribution
Nationwide and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR

by Baptist Health Medical Towers Pharmacy and Infusion Services

Reason
Lack of Sterility Assurance.
Recall initiated
April 18, 2016
Reported by FDA
June 8, 2016
Distribution
Arkansas

View recall →

Drug Recall Terminated Historical recordClass II

Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR

by Baptist Health Medical Towers Pharmacy and Infusion Services

Reason
Lack of Sterility Assurance
Recall initiated
April 18, 2016
Reported by FDA
June 8, 2016
Distribution
Arkansas

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.