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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 11,961–11,980 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu Tang Success, LLC Trexlertown, PA 18087, USA www.zixiutangsuccess.com

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 Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.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

View recall →

Drug Recall Terminated Historical recordClass I

SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition

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 Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.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

View recall →

Drug Recall Terminated Historical recordClass I

SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceuticals Ltd. MUMBAI-400-030 Manufactured in India by: HAB Pharmaceuticals & Research Limited 10-Pharma City, SIDCUL, Selaqui, Dehradun, 248 197

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 Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.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

View recall →

Drug Recall Terminated Historical recordClass I

Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St. #392 Columbus, IN 47203

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, 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 →

Drug Recall Terminated Historical recordClass I

Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando FL 32801 (407)930-4043

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, 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 →

Drug Recall Terminated Historical recordClass I

La' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Health 37 N Orange Ave Suite 500 Orlando, FL 32801 (407) 930-4043

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, 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 →

Drug Recall Terminated Historical recordClass I

Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Solutions 1810 E. Sahara Ave #100 Las Vegas, Nevada 89104

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, 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 →

Drug Recall Terminated Historical recordClass I

Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition

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

View recall →

Drug Recall Terminated Historical recordClass I

EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E. Atlantic Blvd, Pompano Beach, Florida, 33062 WWW.BEEEXTREMELYAMAZED.COM

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, 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 →

Drug Recall Terminated Historical recordClass I

Asset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com www.allnaturalbeelievers.com

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

View recall →

Drug Recall Terminated Historical recordClass I

Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www.assetcapsules4u.com

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, 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 →

Drug Recall Ongoing Historical recordClass I

Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.

by Hospira Inc.

Reason
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
Recall initiated
March 23, 2016
Reported by FDA
July 13, 2016
Distribution
Nationwide, United Arab Emirates, Kuwait, and Bahrain

View recall →

Drug Recall Terminated Historical recordClass II

All Malarone (atovaquone and proguanil) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

by Reliable Rexall-A Compounding Pharmacy

Reason
Lack of Processing Controls
Recall initiated
March 25, 2016
Reported by FDA
July 13, 2016
Distribution
U.S. Including: CA, HI, NM

View recall →

Drug Recall Terminated Historical recordClass II

All baclofen Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

by Reliable Rexall-A Compounding Pharmacy

Reason
Lack of Processing Controls
Recall initiated
March 25, 2016
Reported by FDA
July 13, 2016
Distribution
U.S. Including: CA, HI, NM

View recall →

Drug Recall Terminated Historical recordClass II

All diethylstilbestrol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

by Reliable Rexall-A Compounding Pharmacy

Reason
Lack of Processing Controls
Recall initiated
March 25, 2016
Reported by FDA
July 13, 2016
Distribution
U.S. Including: CA, HI, NM

View recall →

Drug Recall Terminated Historical recordClass II

All e2-e3-p4 Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

by Reliable Rexall-A Compounding Pharmacy

Reason
Lack of Processing Controls
Recall initiated
March 25, 2016
Reported by FDA
July 13, 2016
Distribution
U.S. Including: CA, HI, NM

View recall →

Drug Recall Terminated Historical recordClass II

All tacrolimus Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

by Reliable Rexall-A Compounding Pharmacy

Reason
Lack of Processing Controls
Recall initiated
March 25, 2016
Reported by FDA
July 13, 2016
Distribution
U.S. Including: CA, HI, NM

View recall →

Drug Recall Terminated Historical recordClass II

All Nitro Paste (nitroglycerin) Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

by Reliable Rexall-A Compounding Pharmacy

Reason
Lack of Processing Controls
Recall initiated
March 25, 2016
Reported by FDA
July 13, 2016
Distribution
U.S. Including: CA, HI, NM

View recall →

Drug Recall Terminated Historical recordClass II

All hydroquinone Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

by Reliable Rexall-A Compounding Pharmacy

Reason
Lack of Processing Controls
Recall initiated
March 25, 2016
Reported by FDA
July 13, 2016
Distribution
U.S. Including: CA, HI, NM

View recall →

Drug Recall Terminated Historical recordClass II

All clobetasol Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

by Reliable Rexall-A Compounding Pharmacy

Reason
Lack of Processing Controls
Recall initiated
March 25, 2016
Reported by FDA
July 13, 2016
Distribution
U.S. Including: CA, HI, NM

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.