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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 17,381–17,400 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass II

Betamethasone Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Recall initiated
April 17, 2013
Reported by FDA
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Sodium Tetradecyl Sulfate Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Recall initiated
April 17, 2013
Reported by FDA
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Recall initiated
April 17, 2013
Reported by FDA
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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Drug Recall Terminated Historical recordClass II

TriMix Standartd (PGE Stock Sol'n) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Recall initiated
April 17, 2013
Reported by FDA
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Lisinopril Tablets, USP 10 mg, Rx only, 1000 count bottles, Manufactured for: Mylan Pharmaceuticals Inc ,Morgantown, WV 26505 U.S.A. Made in India; NDC 0378-20740-10

by Mylan Pharmaceuticals Inc.

Reason
Tablets/Capsules Imprinted With Wrong ID: Pharmaceuticals are imprinted with an incorrect identifier code on the embossed tablets..
Recall initiated
February 26, 2013
Reported by FDA
May 1, 2013
Distribution
Nationwide.

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Drug Recall Terminated Historical recordClass II

Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.

by Sandoz Incorporated

Reason
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Recall initiated
April 18, 2013
Reported by FDA
May 1, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

WOW, Health Enterprises, Dietary Supplement, 30 Caplets, Distributed by: Health Enterprises, 1002 E 5th St., Canton, SD 57013. Manufactured by Riger Natural, S. A. Mexico.

by Brower Enterprises Inc

Reason
Marketed without an Approved NDA/ANDA: Brower Enterprises Inc., is recalling its WOW Health Enterprises Dietary Supplement, because it contains undeclared drug ingredients making it an unapproved drug. FDA sample analysis has found the product to contain methocarbamol, dexamethasone, and diclofenac.
Recall initiated
December 10, 2012
Reported by FDA
May 1, 2013
Distribution
Nationwide and Puerto Rico (through the internet).

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Drug Recall Terminated Historical recordClass II

Trimix Customs Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

by Axium Healthcare Pharmacy dba Balanced Solutions Compounding

Reason
Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Recall initiated
April 17, 2013
Reported by FDA
May 1, 2013
Distribution
CO, GA, MI, and Puerto Rico

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Drug Recall Ongoing Historical recordClass I

Blue Male Enhancement Pill, bulk product, by The Menz Club, Ridgeland, MS

by The Menz Club, LLC

Reason
Marketed without an Approved NDA/ANDA; product found to contain sulfoaildenafil, an analogue of sildenafil, the active ingredient in a FDA approved product used for erectile dysfunction, making it an unapproved new drug
Recall initiated
March 10, 2012
Reported by FDA
April 24, 2013
Distribution
Utah

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Drug Recall Terminated Historical recordClass I

Actra-SX 500 Capsules, Maximum Strength, Energizer, 500 mg, 5 count package, Body Basics, Canoga Park, CA

by Body Basics Inc

Reason
Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction
Recall initiated
December 19, 2011
Reported by FDA
April 24, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.

by Lupin Pharmaceuticals Inc.

Reason
Discoloration; Product may not meet specifications for color description once reconstituted.
Recall initiated
January 31, 2013
Reported by FDA
April 24, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.

by Hospira Inc.

Reason
Non-Sterility: One confirmed customer report that product contained spore-like particulates, consistent with mold.
Recall initiated
October 5, 2012
Reported by FDA
April 24, 2013
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass I

Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA; NDC 0409-7929-09.

by Hospira Inc.

Reason
Non-Sterility: Confirmed customer complaint of product contaminated with mold.
Recall initiated
January 25, 2013
Reported by FDA
April 24, 2013
Distribution
Nationwide

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Drug Recall Completed Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP 200 mcg, packaged in a) 100-count bottles (NDC 60793-860-01) and b) 1000-count bottles ( NDC 60793-860-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

by Pfizer Inc.

Reason
Chemical contamination: emission of strong odor after package was opened.
Recall initiated
March 28, 2013
Reported by FDA
April 24, 2013
Distribution
Nationwide and PR

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Drug Recall Completed Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP 175 mcg, packaged in a) 100-count bottles (NDC 60793-859-01) and b) 1000-count bottles ( NDC 60793-859-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

by Pfizer Inc.

Reason
Chemical contamination: emission of strong odor after package was opened.
Recall initiated
March 28, 2013
Reported by FDA
April 24, 2013
Distribution
Nationwide and PR

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Drug Recall Completed Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP 150 mcg, packaged in a) 100-count bottles (NDC 60793-858-01) and b) 1000-count bottles ( NDC 60793-858-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

by Pfizer Inc.

Reason
Chemical contamination: emission of strong odor after package was opened.
Recall initiated
March 28, 2013
Reported by FDA
April 24, 2013
Distribution
Nationwide and PR

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Drug Recall Completed Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP 137 mcg, packaged in a) 100-count bottles (NDC 60793-857-01) and b) 1000-count bottles ( NDC 60793-857-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

by Pfizer Inc.

Reason
Chemical contamination: emission of strong odor after package was opened.
Recall initiated
March 28, 2013
Reported by FDA
April 24, 2013
Distribution
Nationwide and PR

View recall →

Drug Recall Completed Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP 125 mcg, packaged in a) 100-count bottles (NDC 60793-856-01) and b) 1000-count bottles ( NDC 60793-856-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

by Pfizer Inc.

Reason
Chemical contamination: emission of strong odor after package was opened
Recall initiated
March 28, 2013
Reported by FDA
April 24, 2013
Distribution
Nationwide and PR

View recall →

Drug Recall Completed Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP 112 mcg, packaged in a) 100-count bottles (NDC 60793-855-01) and b) 1000-count bottles ( NDC 60793-855-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

by Pfizer Inc.

Reason
Chemical contamination: emission of strong odor after package was opened.
Recall initiated
March 28, 2013
Reported by FDA
April 24, 2013
Distribution
Nationwide and PR

View recall →

Drug Recall Completed Historical recordClass II

Levoxyl (levothyroxine sodium) tablets, USP 100 mcg, packaged in a) 100-count bottles (NDC 60793-854-01) and b) 1000-count bottles ( NDC 60793-854-10 ) Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620.

by Pfizer Inc.

Reason
Chemical contamination: emission of strong odor after package was opened..
Recall initiated
March 28, 2013
Reported by FDA
April 24, 2013
Distribution
Nationwide and PR

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.