Drug Guide -> Drug Recalls, Alerts, and Warnings
FDA Recalls, Alerts, and Warnings
Welcome to the FDA Recalls, Alerts, and Warnings page. Here you will find an up-to-date list of drugs for which the Food and Drug Administration (FDA) has issued a recall, alert, or warning. To read the accompanying FDA press release on any drug listed below, simply click on the title of the release.
This page was last updated on
April 03, 2006
| Date | Generic Name | Trade Name | Details |
| May 11, 2006
| contact lens cleaning solution
| ReNu with MoistureLoc®
|  |
| May 2, 2006
| acetaminophen
| Goldline ® brand Extra Strength Genapap 500mg caplets and tablets and Extra Strength Genebs 500mg caplets and tablets
| |
| March 17, 2006
| mifepristone
| Mifeprex
| |
| March 9, 2006
| dietary supplements
| Anabolic Xtreme Superdrol and Methyl-1-P
| |
| February 24, 2006
| dietary supplements containing ephedrine alkaloids
| Lipodrene, Stimerex-ES and Betadrene
| |
| February 16, 2006
| gatifloxacin
| Tequin
| |
| February 13, 2006
| salt solution
| Balanced Salt Solution
| |
| February 8, 2006
| aprotinin injection
| Trasylol
| |
| February 3, 2006
| human cells, tissues, and cellular and tissue-based products
| none given
| |
| January 20, 2006
| bogus flu products
| Warning about all bogus flu products, such as counterfeit Tamiflu.
| |
| January 19, 2006
| pimecrolimus and tacrolimus
| Elidel Cream and Protopic Ointment
| |
| January 13, 2006
| weight loss supplements
| Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill and Herbathin Dietary Supplement
| |
| January 12, 2006
| dietary supplement containing ephedrine alkaloid
| Lipodrene
| |
| December 19, 2005
| medical testing device
| NeutroSpec [Technetium (99m TC) Fanolesomab]
| |
| December 16, 2005
| illegal prescription drugs imported into this country
| not identified
| |
| December 16, 2005
| medical device
| Meridian Hemodialysis Instrument with model numbers 5M5576 and 5M5576R
| |
| December 13, 2005
| bogus flu products
| Nature's Biotics, Lingoji, Natural Cellular Defense, Immunity Plus, Immunocil™, Vira 38, NSI GliSODin®, NSI Superior Ester-C with Quercetin and Bioflavonoids; NSI Vitamin C; NSI Green Tea Extract, NSI Activated Quercetin Complex, NSI Probiotic with Acidophilus, Rhamnosus, Thermophilus and Bulgaricus, NSI AHCC+ Immune Power, NSI L-Optizinc and ZymePro Plus™ w/Serrapeplase
| |
| December 6, 2005
| herbal supplement
| Nature's Treat Energy Plus #1
| |
| November 29, 2005
| various eye drops
| Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C, as well as several OTC pain relieving drugs - Biogesic, Bio-Ice and Bio-Heat
| |
| October 26, 2005
| human tissue - including bone, skin and tendons.
| none given
| |
| October 26, 2005
| blood glucose meters
| FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense, Sof-Tact, Precision Sof-Tact, MediSense, Optium, Precision Sof-Tact meters, and private label brands ReliOn Ultima, Rite Aid and Kroger blood glucose meters
| |
| October 24, 2005
| weight loss drugs
| various
| |
| October 17, 2005
| flu vaccine
| various
| |
| October 14, 2005
| infusion pumps
| SYNDEO PCA Syringe Pumps, Colleague Volumetric Infusion Pumps, and Colleague CX Volumetric Infusion Pumps, respectively
| |
| October 6, 2005
| calibration sets
| VeriCal® Calibrator Sets
| |
| September 30, 2005
| Pmeningococcal conjugate vaccine A, C, Y, and W135
| Menactra
| |
| September 29, 2005
| atomoxetine
| Strattera
| |
| September 15, 2005
| Positron Emission Tomography (PET) drugs
| none
| |
| August 29, 2005
| mouthwash and hygiene kits
| Medline brand alcohol-free mouthwash
| |
| August 12, 2005
| isotretinoin
| Accutane, Amnesteemm, Claravis and Sotret
| |
| July 29, 2005
| counterfeit atorvastin
| counterfeit "Lipitor"
| |
| July 27, 2005
| Certain cough and cold liquids, tablets, and caplets
| none
| |
| July 21, 2005
| intraveneous delivery system
| Colleague Volumetric Infusion Pumps
| |
| July 19, 2005
| mifepristone and misoprostol
| Mifeprex, also known as RU-486, and Cytotec
| |
| July 15, 2005
| transdermal fentanyl
| Duragesic
| |
| July 13, 2005
| hydromorphone hydrochloride
| Palladone
| |
| July 8, 2005
| tadalafil, vardenafil and sildenafil
| Cialis, Levitra and Viagra
| |
| July 1, 2005
| dietary supplement
| Liqiang 4 dietary supplement capsules
| |
| June 24, 2005
| Enclosed bed systems
| None
| |
| June 17, 2005
| defibrillators and cardiac resynchronization therapy
| PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002, CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004, CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
| |
| June 3, 2005
| Acetaminophen
| Children's TYLENOL® Meltaways 80 mg packaged in bottles and blisters, Children's TYLENOL® SoftChews 80mg packaged in blisters, and Junior TYLENOL® Meltaways 160mg packaged in blisters.
| |
| May 27, 2005
| manufactured drugs (mostly generic prescription drugs, including drugs containing acetaminophen)
| none
| |
| May 20, 2005
| dextromethorphan
| Various
| |
| May 18, 2005
| Over-the-counter supplement
| Fortified Mineral Neutralizer and Ultra Fortified Mineral Neutralizer
| |
| May 10, 2005
| Counterfeit versions of Lipitor, Viagra, and an unapproved product promoted as "generic Evista"
| Counterfeit versions of medications to treat cholesterol and sexual problems
| |
| May 10, 2005
| Automatic external defibrillators
| AED20 Automatic External Defibrillators
| |
| April 28, 2005
| various
| various prescription drugs
| |
| April 28, 2005
| paroxetine HCI
| Paxil
| |
| April 11, 2005
| aripiprazole, olanzapine, quetiapine, risperidone, clozapine and ziprasidone, and olanzapine/fluoxetine.
| Abilify, Zyprexa, Seroquel, Risperdal, Clozaril, Geodon and Symbyax
| |
| April 7, 2005
| valdecoxib, celecoxib
| Bextra, Celebrex
| |
| March 31, 2005
| Albuterol metered-dose inhalers (MDIs) using chlorofluorocarbon (CFC) propellants
| None
| |
| March 22, 2005
| enclosed bed systems
| Vail 500, 1000 and 2000 Enclosed Bed Systems
| |
| March 18, 2005
| magnesium sulfate solution
| PharMEDium Services magnesium sulfate 1 gram in 50mL D5W (piggyback) IV solution
| |
| March 10, 2005
| pimecrolimus and tacrolimus
| Elidel and Protopic
| |
| March 4, 2005
| paroxetine hydrochloride and rosiglitazone maleate, and metformin hydrochloride
| Paxil CR and Avandamet tablets
| |
| March 2, 2005
| rosuvastatin calcium
| Crestor
| |
| February 28, 2005
| nataluzimab
| Tysabri
| |
| February 25, 2005
| ephedrine alkaloids
| SciFit Procuts and Thermogen
| |
| February 7, 2005
| Home-use test kits
| Rapid HIV Test Kit, Rapid Syphilis Test Kit, One Step Cassette Style Cocaine Test, One Step Cassette Style Marijuana Test, One Step Cassette Style Amphetamine Test, Rapid Dengue Fever Test and One Step Midstream Style HCG Urine (Home), Pregnancy Test
| |
| January 31, 2005
| Preloaded syringe
| None
| |
| December 27, 2004
| gabapentin and itraconazole
| Neurontin and Sporanox
| |
| December 20, 2004
| naproxen
| Various
| |
| December 17, 2004
| gefitinib
| Iressa
| |
| December 17, 2004
| atomoxetine
| Straterra
| |
| December 17, 2004
| celecoxib
| Celebrex
| |
| December 16, 2004
| ginseng
| Ginseng
| |
| December 9, 2004
| valdecoxib
| Bextra
| |
| December 8, 2004
| lithium carbonate
| Carbolith
| |
| December 1, 2004
| Two drugs: penicillin G benzathine/penicillin G procaine injectable suspension and penicillin G benzathine injectable suspension
| Bicillin CR and Bicillin LA
| |
| November 23, 2004
| ephedra-containing supplement
| VITERA-XT
| |
| November 17, 2004
| medroxyprogesterone
| Depo-Provera Contraceptive Injection
| |
| November 15, 2004
| mifepriston
| Mifeprex, also known as RU-486
| |
| November 2, 2004
| Supplements
| Actra-Rx and Yilishen
| |
| September 30, 2004
| rofecoxib
| Vioxx
| |
| September 24, 2004
| Cochlear implant hearing aids
| CLARION and HiResolution cochlear implants
| |
| August 23, 2004
| Mammograms
| None
| |
NOTE: Click on the
to read the details of the recall.
| Date | : | March 9, 2006
|
| Generic Name | : | dietary supplements
|
| Trade Name | : | Anabolic Xtreme Superdrol and Methyl-1-P
|
| Manufacturer | : | Anabolic Resources LLC, Gilbert, Arizona, and distributed by Supplements To Go, Cincinnati, Ohio (Anabolic Xtreme Superdrol); and Legal Gear, Brighton, MI and distributed by Affordable Supplements, Wichita, Kansas (Methyl-1-P)
|
| Type of Drug/Product | : | dietary supplements meant to increase strength
|
| FDA Release | : |
The FDA warned several manufacturers and distributors of unapproved drugs containing steroids that continuing to sell these products without FDA approval could mean these products will be seized. The FDA is concerned that these products, which are marketed as dietary supplements and promoted for building muscle and increasing strength, may damage the liver, cause male infertility, raise the risk of heart attack and stroke, and stunt growth in children.
|
| Date | : | December 13, 2005
|
| Generic Name | : | bogus flu products
|
| Trade Name | : | Nature's Biotics, Lingoji, Natural Cellular Defense, Immunity Plus, Immunocil™, Vira 38, NSI GliSODin®, NSI Superior Ester-C with Quercetin and Bioflavonoids; NSI Vitamin C; NSI Green Tea Extract, NSI Activated Quercetin Complex, NSI Probiotic with Acidophilus, Rhamnosus, Thermophilus and Bulgaricus, NSI AHCC+ Immune Power, NSI L-Optizinc and ZymePro Plus™ w/Serrapeplase
|
| Manufacturer | : | Sacred Mountain Management Inc, BODeSTORE.com, Melvin Williams, Iceland Health, Inc., PolyCil Health Inc., PRB Pharmaceuticals, Chozyo, LLC, Vitacost.com, Inc and Healthworks 2000
|
| Type of Drug/Product | : | Several bogus flu products
|
| FDA Release | : |
The FDA issued warning letters to nine companies marketing bogus flu products. These companies claim their products could help prevent the avian flu or other forms of the flu. The FDA is not aware of any evidence that shows that these are safe and do what the label claims. The agency is concerned that the use of these products could harm consumers or interfere with standard medical treatments.
|
| Date | : | December 6, 2005
|
| Generic Name | : | herbal supplement
|
| Trade Name | : | Nature's Treat Energy Plus #1
|
| Manufacturer | : | Nature's Treat, Inc., Gainesville, Texas and ACD Distributing, LLC, of Eugene, Oregon
|
| Type of Drug/Product | : | Herbal supplement
|
| FDA Release | : |
At the request of the FDA, the U.S. Attorney's Office for the Eastern District of Texas and the U.S. Attorney's Office for the District of Oregon filed Complaints for Forfeiture against Nature's Treat Energy Plus #1, a dietary supplement that contains ephedra, an herbal source of ephedrine alkaloids. This substance can have potentially dangerous effects on the heart.
|
| Date | : | November 29, 2005
|
| Generic Name | : | various eye drops
|
| Trade Name | : | Oxydrops, Bright Eyes, Bright Eyes II, Clarity Vision for Life, Visitein, and Can-C, as well as several OTC pain relieving drugs - Biogesic, Bio-Ice and Bio-Heat
|
| Manufacturer | : | MBI Distributing, Inc., also known as Molecular Biologics
|
| Type of Drug/Product | : | Over-the-counter medications
|
| FDA Release | : |
The FDA announced that MBI Distributing, Inc. has signed a consent decree that requires it to stop manufacturing and distributing drugs until it corrects manufacturing deficiencies and other violations at its Benicia, California facility. The FDA also determined that two of the firm's eye drop brands, Visitein and Clarity Vision for Life, are unapproved drugs. In addition, Biogesic, Bio-Ice and Bio-Heat do not provide adequate warnings for their safe use.
|
| Date | : | October 26, 2005
|
| Generic Name | : | blood glucose meters
|
| Trade Name | : | FreeStyle, FreeStyle Flash, FreeStyle Tracker, Precision Xtra, MediSense, Sof-Tact, Precision Sof-Tact, MediSense, Optium, Precision Sof-Tact meters, and private label brands ReliOn Ultima, Rite Aid and Kroger blood glucose meters
|
| Manufacturer | : | Abbott Diabetes Care, Alameda, California
|
| Type of Drug/Product | : | Treatment of diabetes
|
| FDA Release | : |
The FDA is alerting patients about a problem with blood glucose meters made by Abbott Diabetes Care. The meters can unintentionally be switched from one unit of measurement to another, resulting in an inaccurate blood glucose reading by the user. An inaccurate reading can lead to taking the wrong dose of insulin or to dietary changes, resulting in higher levels of blood sugar or hyperglycemia.
|
| Date | : | September 30, 2005
|
| Generic Name | : | Pmeningococcal conjugate vaccine A, C, Y, and W135
|
| Trade Name | : | Menactra
|
| Manufacturer | : | Sanofi Pasteur
|
| Type of Drug/Product | : | Protects against meningococcal infection, a major cause of bacterial meningitis.
|
| FDA Release | : |
The FDA and Centers for Disease Control and Prevention are alerting consumers and health care providers to five reports of guillain barre syndrome (GBS) following administration of meningococcal conjugate vaccine A, C, Y, and W135. It is not known yet whether these cases were caused by the vaccine or are coincidental. GBS is a serious neurological disorder that can occur, often in healthy people, either spontaneously or after certain infections. GBS typically causes increasing weakness in the legs and arms that can be severe and can require hospitalization.
|
| Date | : | August 12, 2005
|
| Generic Name | : | isotretinoin
|
| Trade Name | : | Accutane, Amnesteemm, Claravis and Sotret
|
| Manufacturer | : | Roche Pharmaceuticals Inc, Mylan Pharmaceuticals Inc., Barr Laboratories, Inc., Ranbaxy Laboratories, Inc
|
| Type of Drug/Product | : | Treatment of severe acne
|
| FDA Release | : |
The FDA approved a strengthened distribution program for isotretinoin, called iPLEDGE, aimed at preventing use of the drug during pregnancy. Women who are pregnant or who might become pregnant should not take the drug because of a high risk of birth defects.
|
| Date | : | July 29, 2005
|
| Generic Name | : | counterfeit atorvastin
|
| Trade Name | : | counterfeit "Lipitor"
|
| Manufacturer | : | none
|
| Type of Drug/Product | : | Treatment of high cholesterol
|
| |
