MedWatch, The FDA Safety Information and Adverse Event Reporting Program, is your Internet gateway for timely safety information on the dietary supplements, drugs and other medical products regulated by the U.S. Food and Drug Administration.
- Brazilian Diet Pills (Emagrece Sim and Herbathin products)
- Diabetisource AC
- Dietary Supplements Promoted for Sexual Enhancement: Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON
- Ellagimax Capsules, Coral Max Capsules, Coral Max without Iron Capsules, and Advanced Arthritis Support Capsules
- Encore Supplement Tablets
- Ephedrine Alkaloid Products
- Ephedrine Dietary Supplements
- Gamma Butyrolactone (GBL)
- GBL, gamma
hydroxybutyric acid (GHB) and 1,4 butanediol (BD)
- GBL-Related
Products
- Health Nutrition
(RMA Labs) Viga or Viga for Women Tablets
- Herbal Fen-Phen
- Herbal Science International, Inc. Dietary Herbal Supplements
- Illegal Steroid Products: Anabolic Xtreme Superdrol and Methyl-1-P
- Kava-containing Dietary Supplements (Piper methysticum)
- Lipokinetix
- Liqiang 4 Dietary Supplement Capsules
- Liviro3 Dietary Supplement Recall
- Long Weekend Dietary Supplement
Total Body Formula, Total Body Mega Formula
Audience: Consumers and healthcare professionals
[UPDATE 05/01/2008] FDA notified healthcare professionals and consumers that the Agency's final analysis of certain flavors of "Total Body Formula" and "Total Body Mega Formula" detected hazardous amounts of chromium in addition to selenium. Excessive consumption of chromium can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. Excessive chromium intake can also interfere with certain medications. FDA continues to investigate how excessive amounts of selenium and chromium got into the products.
[UPDATE 04/10/2008] The FDA notified healthcare professionals and patients that it has found hazardous levels of selenium in samples of certain flavors of the dietary supplement products "Total Body Formula" and "Total Body Mega Formula." Analyses of samples by FDA have found most of the samples contain extremely high levels of selenium -- up to 200 times the amount of selenium indicated on the labels of the products. The FDA has received 43 reports of persons from nine states who experienced serious adverse reactions using these products. The adverse reactions generally occurred after five to 10 days of daily ingestion of the product, and included significant hair loss, muscle cramps, diarrhea, joint pain, deformed fingernails, and fatigue. Consumers should stop taking the products and consult their healthcare professional if they experience any adverse events associated with the use of the products.
[Posted 03/28/2008] The FDA notified consumers of a recall of, and advised them not to purchase or consume, the liquid dietary supplement products Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. FDA laboratories are analyzing samples of the products to identify the cause of the reactions.
[May 01, 2008 (News Release) - FDA]
[April 09, 2008 (News Release) - FDA]
[March 27, 2008 (News Release) - FDA]
Back to Top
Herbal Science International, Inc. Dietary Herbal Supplements
Audience: Consumers and healthcare professionals
[Posted 04/14/2008] Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. FDA has long regarded dietary supplements containing ephedra, a botanical that contains ephedrine alkaloids, as a potential health hazards because the alkaloid raises blood pressure and otherwise stress the circulatory system. These effects are linked to adverse health effects like heart attacks and stroke. FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.
Two of the recalled products contain aristolochic acid which is a potent carcinogen and nephrotoxin. This chemical can cause serious kidney damage and has been associated with several occurrences of kidney failure. The twelfth recalled product contains human placenta, an ingredient which may transmit disease. Dietary supplements that contain human placenta may not be lawfully marketed in the United States. No illnesses have been reported in connection with the recalled products and distribution of all of the products has ceased. Consumers should immediately discontinue use of the recalled products and return the product(s) to their place of purchase.
[April 10, 2008 (Press Release ) - Herbal Science International]
Back to Top
"Blue Steel" and "Hero" Dietary Supplement Products
Audience: Consumers
[Posted 03/25/2008] The U.S. Food and Drug Administration is advising consumers not to purchase or use "Blue Steel" or "Hero" products, marketed nationally as dietary supplements, because these products contain undeclared ingredients, which may dangerously affect a persons blood pressure level. They are considered unapproved drugs and have not been proven to be safe or effective. These products are promoted and sold over the Internet for the treatment of erectile dysfunction [ED] and for sexual enhancement. They contain undeclared and unapproved substances similar in chemical structure to sildenafil, the active ingredient in an FDA-approved prescription drug for ED. The undeclared ingredients in these products may interact with nitrates found in some prescription drugs (such as nitroglycerin), and can lower blood pressure to dangerous levels.
[March 25, 2008 (Press Release ) - FDA]
Back to Top
Aspire36, Aspire Lite Dietary Supplements
Audience: Consumers and healthcare professionals
[Posted 03/04/2008] Palo Alto Labs and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of two dietary supplements, Aspire36 and Aspire Lite. The products were recalled because they were found to contain Aildenafil in trace amounts and Dimethyl sildenafil thione, an analog of Sildenafil, a drug used to treat erectile dysfunction. The presence of these ingredients in the dietary supplements may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have Aspire36 and Aspire Lite in their possession should stop using the products and return any unused product to the place of purchase.
[February 28, 2008 (Press Release ) - Palo Alto Labs]
Back to Top
Zencore Tabs
Audience: Consumers and healthcare professionals
[Posted 09/07/2007] Bodee LLC, Inc., issued a nationwide recall of Zencore Tabs, a product marketed as a dietary supplement, because it contains undeclared ingredients. FDA laboratory analysis of Zencore Tabs found that the product contains aminotadalafil, an analog of tadalafil, and sildenafil, both of which are active ingredients of FDA-approved drugs used for Erectile Dysfunction. The product also contained sulfosildenafil and sulfohomosildenafil which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers who have this product should stop using it immediately and consult their healthcare professional if they experience any problems that may be due to this product.
[August 31, 2007 (Press Release ) - Bodee LLC, Inc.]
Back to Top
Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, Shangai Regular (also known as Shangai Chaojimengnan
Audience: Consumers and healthcare professionals
[Posted 12/31/2007] FDA notified consumers and healthcare professionals not to buy or use Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, and Shangai Regular (also known as Shangai Chaojimengnan) products. The products are marketed as dietary supplements and used for the treatment of erectile dysfunction (ED) and for sexual enhancement. The products do not qualify as dietary supplements because they contain undeclared active ingredients of FDA-approved prescription drugs for ED. The products are thus drugs that are illegal because they lack FDA approval. Additionally, because the manufacturing source of the active ingredients in these products is unknown, consumers should be aware that the safety, efficacy, and purity of the ingredients can not be validated.
The undeclared ingredients in the referenced products may interact with nitrates found in some prescription drugs (such as nitroglycerin) and can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take products containing nitrates. Consumers who have these products should discontinue using them and consult their healthcare professional.
[December 28, 2007 (News Release ) - FDA]
Back to Top
METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules
Audience: Consumers and healthcare professionals
[Posted 08/21/2007] Confidence Inc. informed consumers and healthcare professionals that the company is recalling one lot of METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules (Lot: 3001006, Exp. 10/2009) because the product contains the undeclared drug ingredient sibutramine, an FDA approved drug used as an appetite suppressant for weight loss. The FDA has not approved METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules as a drug, therefore the safety and effectiveness of this product is unknown.
The use of sibutramine may pose a threat to consumers because it is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Consumers should return any unused product to the manufacturer.
[August 17, 2007 (Press Release) - Confidence Inc.]
Back to Top
Encore Supplement Tablets
Audience: Consumers and healthcare professionals
[Posted 11/26/2007] Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of Encore Tablets, a dietary supplement sold in health food stores, via the internet and by mail order nationwide and in Canada. The product was recalled because it contains potentially harmful, undeclared ingredients. One lot of the product contained aminotadalafil, an analog of tadalafil, the active ingredient of a FDA-approved drug used for Erectile Dysfunction. The undeclared chemical poses a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers who have this product should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
[November 21, 2007 ( Press Release) - Bodee LLC]
Back to Top
DermaFreeze365 Products
Audience: Consumers and healthcare professionals
[Posted 03/28/2007] Woodridge Labs and FDA informed consumers and healthcare professionals of a recall of all lots of its DermaFreeze365 Instant Line Relaxing Formula and DermaFreeze365 Neck and Chest products. The products were recalled because certain lots tested positive for Pseudomonas aeruginosa bacteria. The bacteria may cause serious eye infections, urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients who are immunosuppressed. Because DermaFreeze365 Instant Line Relaxing Formula may be applied in the area of the eye, there is a possibility that if the recalled product is inadvertently introduced in the eye, it could result in serious eye infections and, in rare circumstances, possible blindness.
[March 23, 2007 (Press Release ) - Woodridge Labs]
Back to Top
Cholestrix (Red Yeast Rice/Policosanol Complex)
Audience: Consumers and healthcare professionals
[Posted August 09, 2007] FDA warns consumers and healthcare professionals to avoid using Red Yeast Rice and Red Yeast Rice/Policosanol Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Natures Value Inc. and Kabco Inc., respectively; and Cholestrix, sold by Sunburst Biorganics because the products may contain an unauthorized drug that could be harmful to their health. The products, promoted and sold over the internet as treatments for high cholesterol, contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for high cholesterol.
Lovastatin can cause severe muscle problems leading to kidney impairment. The risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of muscle adverse reactions such as nefazodone (an antidepressant), certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol lowering agents. Consumers who use any red yeast rice products should consult their healthcare provider if they experience any problems that may be due to these products.
[August 09, 2007 (News Release ) - FDA]
Back to Top
Baby's Bliss Gripe Water, Apple flavor
Audience: Consumers, caregivers, pediatricians, other healthcare providers
[Posted 09/21/2007] MOM Enterprises Inc., and FDA informed consumers and healthcare providers that Baby's Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of October 2008 (10/08) is being recalled due to the presence of Cryptosporidium infection. The product is labeled Baby's Bliss. Pediatrician Recommended Gripe Water. Apple Flavor. An herbal supplement used to ease the gas and stomach discomfort often associated with colic, hiccups, and teething in infants and children.
FDA is investigating the illness of a 6-week old infant who consumed the product. The most common symptom of Cryptosporidium infection is watery diarrhea. Other symptoms include dehydration, weight loss, stomach cramps or pain, fever, nausea, and vomiting. Symptoms generally begin two to ten days after becoming infected with the parasite and generally last one to two weeks. The infection could be life-threatening for certain individuals, including infants, children, and individuals with weakened immune systems.
FDA advises parents/caregivers of children who have recently consumed Baby's Bliss Gripe Water, apple flavor, and have these symptoms to seek immediate medical attention. Parents and caregivers who have given this product to their infants and children should be alert for diarrhea and other signs of Cryptosporidium infection. FDA advises consumers to stop using this product and throw away bottles of the product immediately.
[September 20, 2007 (News Release ) - FDA]
Back to Top
Axcil and Desirin (marketed as dietary supplements)
Audience: Consumers, healthcare professionals
[Posted 09/21/2007] TWC Global LLC, Inc., issued a nationwide recall of Axcil and Desirin, both marketed as dietary supplements, because they contain potentially harmful, undeclared ingredients. FDA laboratory analysis of Axcil and Desirin found that the lot of 02B07 contained 3mg/g of sildenafil, the active ingredient of a FDA approved drug used for Erectile Dysfunction (ED). The products also contained sulfosildenafil and sulfohomosildenafil, which are analogs of sildenafil. All of these undeclared chemicals pose a threat to consumers because they may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Sexual dysfunction is a common problem in men and women with these conditions, and consumers may seek these types of products to enhance sexual performance. Consumers who have these products should stop using them immediately and consult their healthcare professional if they experience any problems that may be due to these products.
[September 12, 2007 (Recall Notice) - FDA]
Back to Top
Abbott Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron
Audience: Consumers, healthcare professionals
[Posted 05/29/2007] Abbott informed consumers and healthcare professionals of a nationwide recall of three lots of two-ounce bottles of Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron, a highly specialized liquid ready-to-feed formula used only for premature infants after discharge from the hospital. The three lots of formula were recalled because they do not contain as much iron as indicated on the label. The formula was distributed in the United States between November 2006 and May 2007. Premature infants fed this formula for more than a month after discharge could have an increased risk of developing anemia due to insufficient iron intake. If parents have concerns about their baby's health, they should contact their baby's doctor or healthcare professional. No other liquid or powdered Similac Infant formulas were affected. See the attached manufacturer's press release for a list of stock code and lot numbers for formula affected by this recall.
[May 25, 2007 (News Release ) - Abbott
Back to Top
Liviro3 Dietary Supplement Recall
Audience: Consumers and healthcare professionals
[Posted 01/25/2007] FDA and Ebek, Inc. notified healthcare professionals and consumers of a voluntary nationwide recall of the company's dietary supplement because the product contains tadalafil, a drug used to treat erectile dysfunction. Liviro3 is not approved by FDA to treat this condition. Tadalafil may interact with nitrates found in some prescription drugs and may lower blood pressure to dangerous levels. Consumers who have Liviro3 should stop using it immediately and contact their physician if they experience any problems that may be related to taking this product.
[January 19, 2007 – Press Release – Ebek]
Back to Top
Rhino Max (Rhino V Max) supplement product
Audience: Consumers and healthcare professionals
[Posted 03/16/2007] Cosmos Trading, Inc. and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name Rhino Max (Rhino V Max) in 5-tablet boxes or 15-tablet boxes. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have Rhino Max (Rhino V Max) in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.
[March 16, 2007 - Press Release - Cosmos Trading, Inc.]
Back to Top
V.MAX supplement product
Audience: Consumers and healthcare professionals
[Posted 03/19/2007] Barodon SF and FDA notified consumers and healthcare professionals of a voluntary nationwide recall of a supplement product sold under the name V.MAX. Lab analysis by FDA of product samples found the product contains Aminotadalafil, an analogue of Tadalafil, an FDA-approved drug used to treat Erectile Dysfunction (ED). FDA advised that this poses a threat to consumers because Aminotadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have V.MAX in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.
[March 15, 2007 - Press Release - Barodon SF]
Back to Top
True Man and Energy Max Products
Audience: Consumers and healthcare professionals
[Posted 05/10/2007] FDA informed consumers and healthcare professionals regarding the dangers associated with the purchase or use of True Man or Energy Max products promoted and sold as dietary supplements throughout the United States. Both products, promoted as sexual enhancement products and as treatment for erectile dysfunction (ED), are illegal drug products that contain potentially harmful, undeclared ingredients. The undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Both products contain either a thione analog of sildenafil, the active ingredient in Viagra, or a piperadino analog of vardenafil, the active ingredient in Levitra. Both Viagra and Levitra are FDA approved products for the treatment of ED. FDA has not approved True Man and Energy Max, therefore, the safety and effectiveness of these products are unknown. Consumers should discontinue use of these products and consult their healthcare professional about approved treatments for ED.
[May 10, 2007 - News Release - FDA]
Back to Top
NBTY Shark Cartilage Capsules
Audience: Consumers and healthcare professionals
[UPDATE 06/06/07] Action Labs recalled its Sentinel brand of Shark Cartilage capsules manufactured by NBTY in 2005 because the product may be contaminated with Salmonella.
[Posted 05/17/2007] NBTY and FDA informed consumers and healthcare professionals of a nationwide recall of 3 lots of Shark Cartilage Capsules the company manufactured in 2004 and distributed to consumers through mail and internet orders, and retail stores throughout the United States. The product was recalled because of possible contamination with Salmonella, an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections, endocarditis and arthritis. Customers can return the product back to the place of purchase for a full refund. Read the press release for specific names and lot numbers of the recalled product.
[June 06, 2007 - Press Release - NBTY]
[May 16, 2007 - Press Release - NBTY]
Back to Top
Long Weekend Dietary Supplement
Audience: Consumers and healthcare professionals
Posted 06/15/2007] Confidence, Inc. informed consumers and healthcare
professionals of a nationwide recall of Long Weekend, a product sold as a
dietary supplement through mail orders and retailers located nationwide, and in
Puerto Rico, Canada, the United Kingdom, Russia, and China. The product was
recalled because it contained undeclared tadalafil, an FDA approved drug used to
treat male Erectile Dysfunction (ED). This poses a threat to consumers because
tadalafil may interact with nitrates found in some prescription drugs (such as
nitroglycerin) and may lower blood pressure to dangerous levels. Long Weekend is
not approved by FDA; therefore, the safety and effectiveness of this product is
unknown. Consumers should discontinue use of Long Weekend and consult their
healthcare professional about approved treatments for ED.
[June 14, 2007 - News Release - Confidence, Inc.]
Back to Top
Actra-Rx and Yilishen dietary supplements
Audience: Consumers and healthcare professionals
The FDA warned consumers not to purchase or to consume Actra-Rx or Yilishen, two products promoted and offered for sale on Web sites as "dietary supplements" for treating erectile dysfunction and enhancing sexual performance for men. FDA testing of Actra-Rx found that the product contained undeclared prescription-strength sildenafil. An interaction between sildenafil and certain prescription drugs containing nitrates (such as nitroglycerin) or nitrates found in illicit substances (such as amyl nitrate) may cause a significant lowering of blood pressure to an unsafe level. Consumers who have taken Actra-Rx or Yilishen should stop taking it and consult with their health care providers regarding erectile dysfunction treatment.
[UPDATE December 1, 2004 - Recall Notice - Lot number Actra-Rx 001-3 recalled]
[November 02, 2004 -Talk Paper - FDA]
Back to Top
Diabetisource AC
Audience: Healthcare institutional administrators, healthcare professionals and consumers
[Posted 11/17/2005] FDA and Novartis Nutrition Corporation notified healthcare professionals of a recall of 2,712 bottles of an enteral feeding formula that was incorrectly labeled as Diabetisource AC 1.5 Liter bottles lot 2135L. The affected product was shipped nationwide and is only distributed to healthcare institutional facilities. The bottles contain sodium and calcium caseinate, components of milk. People with an allergy or severe sensitivity to milk may run the risk of a serious or life threatening allergic reaction if they consume this product. Healthcare professionals administering Diabetisource AC to patients who have an allergy or sensitivity to milk should immediately stop using this product.
[November 17, 2005 - Recall Notice - Novartis]
Back to Top
Liqiang 4 Dietary Supplement Capsules
Audience: Consumers and Healthcare professionals
[Posted 07/05/2005] FDA notified consumers and healthcare professionals about the risks of taking Liqiang 4 Dietary Supplement Capsules because they contain glyburide - a drug that could have serious, life-threatening consequences in some people. The product is manufactured by Liqiang Research Institute, China, and marketed throughout the United States in herbal stores and through mail order by Bugle International of Northridge CA. Glyburide is a drug used to lower blood sugar, and is safe and effective when used as labeled in FDA-approved medications. People who have low blood sugar or those with diabetes can receive dangerously high amounts of glyburide by consuming Liqiang 4. Consumers should immediately stop using these products and seek medical attention, especially if they are currently being treated with diabetes drugs or if they have symptoms of fatigue, excessive hunger, profuse sweating, or numbness of the extremities.
[July 01, 2005 - Talk Paper - FDA]
Back to Top
Ellagimax Capsules, Coral Max Capsules, Coral Max without Iron Capsules, and Advanced Arthritis Support Capsules
Audience: Consumers and healthcare professionals
[Posted 09/07/2006] FDA notified healthcare professionals and consumers of the seizure of Ellagimax capsules, Coral Max capsules, Coral Max without Iron capsules, and Advanced Arthritis Support capsules distributed by Advantage Nutraceuticals, LLC, because the products, labeled as dietary supplements, are being promoted to treat serious disease conditions, including but not limited to cancer, arthritis, fibromyalgia, and seizures. The products have not been shown to be safe and effective to treat these conditions and have not been approved by the FDA and are therefore in violation of the new drug and misbranding provisions of the Federal Food, Drug and Cosmetic Act.
FDA advised consumers who may be taking these products to consult their physicians.
[September 06, 2006 - News Release - FDA]
Back to Top
Illegal Steroid Products Sold as Dietary Supplements
Audience: Healthcare professionals and consumers
[Posted 03/10/2006] The FDA warned several manufacturers and distributors of unapproved drugs containing steroids that are marketed as dietary supplements and promoted for building muscle and increasing strength that the products may cause serious long-term adverse health consequences in men, women, and children. These products claim to be anabolic and problems associated with anabolic steroids include: liver toxicity, testicular atrophy and male infertility, masculinization of women, breast enlargement in males, and short stature in children. Anabolic steroids are also associated with causing adverse effects on blood lipid levels, and a potential to increase the risk of heart attack and stroke.
Consumers who have any of the following products should stop taking them and return them to their place of purchase:
Anabolic Xtreme Superdrol - manufactured for Anabolic Resources LLC, Gilbert, Arizona
Methyl-1-P, manufactured for Legal Gear, Brighton, MI
[March 09, 2006 - Press Release - FDA]
Back to Top
Brazilian Diet Pills (Emagrece Sim and Herbathin products)
Audience: Consumers and all healthcare professionals
[Posted 01/13/2006] The FDA warned consumers not to use two unapproved drug products that are being marketed as dietary supplements for weight loss. Emagrece Sim Dietary Supplement, also known as the Brazilian Diet Pill, and Herbathin Dietary Supplement may contain several active ingredients, including controlled substances, found in prescription drugs that could lead to serious side effects or injury. They contain chlordiazepoxide HCl (the active ingredient in Librium), and fluoxetine HCl (the active ingredient in Prozac). Emagrece Sim and Herbathin were also found to contain Fenproporex, a stimulant that is not approved for marketing in the United States. Consumers are advised not to use the Emagrece Sim and Herbathin products and to return them to the suppliers. There may be other manufacturers or suppliers of imported Emagrece Sim and Herbathin, and consumers should exercise caution in using any of these imported products.
[January 13, 2006 - News Release - FDA]
Back to Top
Dietary Supplements Containing Ephedrine Alkaloids
Audience: Consumers and healthcare professionals
[Posted 08/22/2006] FDA informed consumers and healthcare professionals that all dietary supplements containing ephedrine alkaloids are illegal to market in the United States. Dietary supplements containing ephedrine alkaloids, regardless of the dosage, are considered adulterated and pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure. FDA conducted an exhaustive evaluation of relevant scientific data evidence on ephedrine alkaloids before issuing this decision in a final rule in 2004. On August 17, 2006, a Court of Appeals ruling upheld this final rule, reversing an earlier decision by the District Court of Utah.
[Aug 21, 2006 - News Release - FDA]
Back to Top
Dietary Supplements Promoted for Sexual Enhancement
Audience: Consumers and healthcare professionals
[Posted 07/13/2006] The FDA notified healthcare professionals and consumers of a warning not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON, illegal drugs with undeclared ingredients that are promoted and sold on web sites as "dietary supplements" for treating erectile dysfunction and enhancing sexual performance. These products have not been approved by FDA, and there is no guarantee of their safety and effectiveness, or of the purity of their ingredients. They pose a threat to consumers because the undeclared ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises consumers who have used any of these products to discontinue use and to consult their healthcare provider.
[July 12, 2006 - News Release - FDA]
Back to Top
Ancom Anti-Hypertensive Compound Tablet
Audience:
Pharmacists, other healthcare professionals, and consumers
(January 17, 2003) Herbsland Inc. recalled all 100 tablet bottles of Ancom Anti-Hypertensive Compound Tablets, an unapproved new drug labeled to contain several prescription drug ingredients, including reserpine, diazepam, promethiazine, and hydrochlorothiazide. The sale of a product with this combination of ingredients poses possible serious health risks including sedation, depression, and potentially life-threatening abnormalities of the blood. This recall includes all lot codes of the product remaining on the market. Ancom Tablets were sold without prescriptions to consumers through distributors and retail stores located in the New York City metropolitan area, specifically Manhattan, Brooklyn, and Queens. Nationwide sales are also possible as this product was sold via the Internet.
(UPDATE March 18, 2003) Ancom Tablets were sold without prescriptions to consumers at Tai Chien's retail establishment in New York City. Product was also sold to a distributor in Puerto Rico. At least one illness has been reported to date.
[March 18, 2003 Press Release - Tai Chien Inc.]
[January 17, 2003 Press
Release - Herbsland, Inc.]
Back to Top
Viga Tablets (Best Life International)
Audience:
Healthcare professionals and consumers
Best Life International warned consumers not to purchase or
consume the product known as Viga. This product, which is being marketed as
a dietary supplement, contains the unlabeled drug ingredient sildenafil, which
may pose possible serious health risks to some users. Viga is sold in bottles
of 30 tablets which are distributed by Best Life International Inc. This product
is being promoted for increasing desire, confidence and sexual performance.
The product is sold without medical prescription.
The interaction between nitrates and sildenafil can result in profound and
life-threatening lowering of blood pressure. The use of nitrates in any form
is an absolute contraindication for sildenafil users. The potential for this
product to be taken by unknowing nitrate users is real, since erectile dysfunction
is often a concurrent condition in patients with diabetes, hypertension, hyperlipidemia,
smokers and patients with ischemic heart disease.
[May 23, 2003 Press
Release - Best Life International]
Back to Top
Health
Nutrition (RMA Labs) Viga or Viga for Women Tablets
Audience:
Healthcare professionals and consumers
Health Nutrition (RMA Labs) warned consumers not to purchase
or consume the products known as Viga or Viga for Women Tablets. These products,
which are being marketed as dietary supplements, contain the unlabeled drug
ingredient sildenafil, which may pose possible serious health risks to some
users. Viga is sold in bottles of 30 tablets, and in packet of 4 tablets (ten
packets in one small box). VIGA for women is sold in bottle of 20 tablets.
Both products are distributed by Health Nutrition (RMA Laboratories Inc) and
sold without medical prescription.
The interaction between nitrates and sildenafil can result in profound and
life-threatening lowering of blood pressure. The use of nitrates in any form
is an absolute contraindication for sildenafil users. The potential for this
product to be taken by unknowing nitrate users is real, since erectile dysfunction
is often a concurrent condition in patients with diabetes, hypertension, hyperlipidemia,
smokers and patients with ischemic heart disease.
[June 24, 2003 Press
Release - Health Nutrition (RMA Labs)]
Back to Top
Vinarol
Tablets
Audience:
Healthcare professionals and consumers
Ultra Health Laboratories, Inc. and Bionate International,
Inc. warned consumers not to purchase or consume a product known as Vinarol
tablets, promoted for increasing desire, confidence and sexual performance.
This product, marketed as a dietary supplement and sold over the counter as
well as via the Internet, contains the unlabeled prescription drug ingredient,
sildenafil, which may pose possible serious health risks to some users.
The interaction between
nitrates and sildenafil can result in profound and life-threatening lowering
of blood pressure. The use of nitrates in any form is an absolute contraindication
for sildenafil users. The potential for this product to be taken by unknowing
nitrate users is real, since erectile dysfunction is often a concurrent condition
in patients with diabetes, hypertension, hyperlipidemia, smokers and patients
with ischemic heart disease.
[April 4, 2003 Press
Release - Ultra Health Laboratories, Inc.]
Back to Top
Kava-containing Dietary Supplements (Piper methysticum)
Audience:
Healthcare Professionals and Consumers
The FDA Center for Food Safety and Applied Nutrition (CFSAN)
notified healthcare professionals and consumers of the potential risk of severe
liver injury associated with the use of kava-containing dietary supplements.
Supplements containing the herbal ingredient kava are promoted for relaxation
(e.g., to relieve stress, anxiety, and tension), sleeplessness, menopausal
symptoms and other uses. Kava-containing products have been associated with
liver-related injuries, including hepatitis, cirrhosis, and liver failure.
Given these reports, persons who have liver disease or liver problems, or
persons who are taking drug products that can affect the liver, should consult
a physician before using kava-containing supplements. [The links below open
new browser windows with the CFSAN safety alert pages.]
[March 26, 2002 Consumer
Advisory - FDA]
[March 26, 2002 Letter
to Healthcare Professionals - FDA]
Past FDA Alerts
[Dec 19, 2001 Letter
to Healthcare Professionals - FDA]
Back to Top
Nettle Capsules (dietary supplement)
Audience:
Healthcare professionals and consumers
Nature's Way Products, Inc. is recalling four lots of its 100
count Nature's Way brand Nettle capsules because the product contains excessive
amounts of lead. People, especially children, who consume high levels of lead
can suffer serious damage to their central nervous systems, sometimes leading
to permanent neurological damage. The affected lots of the product were distributed
nationwide primarily in health food retail establishments between October
2001 and May 2002. The lot numbers affected by this recall are 131237, 131238,
140738 and 215229.
[June 28, 2002
Press Release - Nature's Way Products]
Back to Top
PC SPES, SPES (BotanicLab)
Audience:
Urologists, Consumers
Consumers were warned to stop using the dietary supplement
/ herbal products PC SPES and SPES capsules because they contain undeclared
prescription drug ingredients that could cause serious health effects if not
taken under medical supervision. Laboratory analysis of the products by the
California Department of Health Services found PC SPES contains warfarin and
SPES contains paparazzo. Warfarin and paparazzo are available only by prescription
and sold either by their generic names or the trade names, Commanding and Anna.
PC SPES and SPES are respectively marketed "for prostate health"
and strengthening the immune system. BotanicLab, the manufacturer of the products,
voluntarily recalled PC SPES and SPES nationwide.
[June 05, 2002
Press Release -CA Dept of Health Services]
[Feb. 08, 2002 Press
Release -CA Dept of Health Services]
[Feb. 08, 2002 Recall Notice - BotanicLab] link no longer available UPDATED September 20,
2002
Back to Top
Aristolochic
Acid
Audience:
Healthcare professionals, particularly Urologists/Nephrologists, and consumers
FDA has issued a Consumer Advisory and sent updated letters
to industry and health professionals to communicate concern about dietary
supplements and botanical products, often marketed as "traditional medicines",
that may contain aristolochic acid. Aristolochic acid has been associated
with nephropathy leading to end stage renal disease and with urological malignancies.
Visit the FDA Center for Food Safety and Applied Nutrition (CFSAN) Aristolochic
Acid web page.
[April 11, 2001 Consumer
Advisory - FDA]
[April 4, 2001 Letter
to Health Professionals - FDA]
[April 9, 2001 Updated
Letter to Industry - FDA]
[Updated April 9, 2001
Listing of Botanical Ingredients of Concern - FDA]
[April 9, 2001 Botanical
Products Determined by FDA to Contain Aristolochic Acid - FDA]
Product Recalls
[August 6, 2001 Recall
of capsules containing Akebia Trifoliata Caulis (Mu Tong) and Asarum Sieboldii
Herba cum Radix (Xi Xin); - Pacific BioLogic Co. Press Release]
[May 24, 2001 Recall
of Joint Ease & Joint Comfort Complex - Vital Nutrients/RHG Press
Release]
[January 25, 2001 Recall
of Neo Concept Aller Relief - BMK International Press Release]
[November 21, 2000 Recall
of Meridian Circulation and Quell Fire - East Earth Herb Inc. Press Release]
Past FDA Actions:
[May 16, 2000 Letter
to Industry - FDA]
[May 31, 2000 Letter
to Health Care Professionals (also in Chinese) - FDA]
Aristolochic Acid
Audience:
Healthcare professionals
Health professionals are
notified of FDA concerns regarding nephrotoxicity associated with botanical
products found to contain aristolochic acid.
[June 1, 2000 (Health
Professional Letter)- FDA/CFSAN.]
[June 1, 2000 (Attachments)-
FDA/CFSAN.]
[June 1, 2000 (Industry
Letter)- FDA/CFSAN.]
Back to Top
Kava (Piper methysticum)
Audience:
Gastroenterologists, Hepatologists, and healthcare professionals
FDA informs healthcare professionals that products containing herbal extracts
of kava have been implicated in Europe in at least 25 cases of serious liver
toxicity including hepatitis, cirrhosis, and liver failure. FDA requests the
assistance of healthcare professionals in reviewing cases of liver toxicity
to determine if any may be related to the use of kava-containing dietary supplements,
and reporting such cases to MedWatch. To read the complete "Dear Healthcare
Professional" letter, click on the link below.[Dec 19, 2001
Letter - FDA / CFSAN] PDF Format ]
Back to Top
Lipokinetix
Audience:
Healthcare professionals, Consumers
The FDA is warning consumers to immediately stop use of the product Lipokinetix,
marketed as a dietary supplement (for weight loss) by Syntrax Innovations,
Inc. FDA has received multiple reports of persons who developed liver injury
or liver failure while using Lipokinetix. The product contains norephedrine
(also known as phenylpropanolamine or PPA), caffeine, yohimbine, diiodothyronine,
and sodium usniate. FDA is also advising consumers to consult their physician
if they are experiencing symptoms possibly associated with this product, particularly
nausea, weakness or fatigue, fever, abdominal pain, or any change in skin
color. [Nov 20, 2001 Letter
- FDA] PDF Format
[Nov 20, 2001 CFSAN
Warnings and Safety Info webpage - FDA]
Back to Top
Neo Concept Aller Relief
Voluntary recall by manufacturer
BMK International after notification from the FDA that the product contains
trace amounts of aristolochic acid, a potent carcinogen and nephrotoxin found
in certain plants and botanicals. (The link opens a new browser window with
the manufacturer's press release)
[January 25, 2001 (Press Release)]
Back to Top
St. John's Wort (hypericum perforatum)
Health professionals are
notified of the risk of drug interactions with St. John's Wort, Indinavir
and other drugs.
[February 10, 2000 (Public
Health Advisory) - FDA.]
Back to Top
Tiratricol (triiodothyroacetic acid)
The FDA is again warning
consumers of products marketed as dietary supplements that contain tiratricol,
a potent thyroid hormone that may cause serious health consequences including
heart attacks and strokes.
[November 22, 2000 (Talk
Paper) - FDA]
Back to Top
Asian Remedy for Menstrual Cramps
CDC reports a case of
adult lead poisoning attributed to an Asian remedy for menstrual cramps, "Koo
Sar" pills, following an investigation by the Adult Lead Registry of
the Connecticut Department of Public Health (CDPH), Division of Environmental
Epidemiology and Occupational Health.
[January 22, 1999 (
MMWR Weekly) - CDC]
Back to Top
Gamma Butyrolactone (GBL)
FDA warns consumers about
products containing GBL, some marketed as dietary supplements. FDA has received
reports of serious health problems - some life-threatening - associated with
their use. Brand names include Renewtrient, Revivarant, Revivarant G, Blue
Nitro, Blue Nitro Vitality, GH Revitalizer, Gamma G and Remforce.
[January 21, 1999 (Talk Paper) - FDA]
[February 26, 1999 ( MMWR
Weekly) - CDC]
Back to Top
GBL-Related Products
FDA warns the public of
a new group of products being marketed as sleep aids that have been associated
with at least 3 deaths and several severe adverse reactions. These products
are chemically related to gamma butyrolactone (GBL) and gamma hydroxybutyric
acid (GHB) substances that have been determined to pose a significant health
hazard to the public.
[May 11, 1999 (Talk
Paper) - FDA]
Back to Top
GBL, gamma hydroxybutyric acid (GHB) and
1,4 butanediol (BD)
FDA has been warning the
public about a group of products sold as dietary supplements for bodybuilding,
weight loss and sleep inducement which have been determined to pose a significant
public health hazard. These products are chemically related to gamma butyrolactone
(GBL), gamma hydroxybutyric acid (GHB), and 1,4 butanediol (BD), and can cause
dangerously low respiratory rates (intubation may be required), unconsciousness/coma,
vomiting, seizures, bradycardia and death.
[August 25, 1999 ( FDA Notification) - FDA]
Back to Top
Ephedrine Dietary Supplements
FDA proposes to limit the amount of ephedrine alkaloids contained in dietary supplement products and require labeling and marketing measures that give adequate warning and information to consumers. Hundreds of illnesses and injuries associated with the use of these products have been reported.
[June 2, 1997 ((HHS News)) - FDA]
Back to Top
5-hydroxy-L-tryptophan
FDA scientists have confirmed
the presence of impurities in some 5-hydroxy-L-tryptophan (5HTP) products
currently marketed and widely promoted as dietary supplements. These products
are being used as aids for insomnia, depression, obesity, and in children
with attention deficit disorder. FDA's analytical results are consistent with
those obtained and published by researchers from the Mayo Clinic.
[August 31, 1998 (Talk
Paper) - FDA]
Back to Top
Cholestin
FDA determines Cholestin,
marketed as a dietary supplement, to be an unapproved drug. Cholestin contains
lovastatin, an active ingredient in the approved prescription drug Mevacor
used to lower cholesterol levels.
[May 20, 1998 (Talk
Paper) - FDA]
Back to Top
Sleeping
Buddha
FDA is warning consumers
not use a product called "Sleeping Buddha". It is marketed as a
dietary supplement but has been determined to contain the prescription-strength
drug ingredient estazolam. Estazolam is known to have serious side effects,
including the potential to cause fetal damage if a pregnant woman consumes
the drug.
[March 10, 1998 (
Statement)- FDA]
Back to Top
Chomper
The FDA warns of potentially
life-threatening heartblock associated with the use of the dietary supplement
Chomper distributed by Arise & Shine of Mount Shasta, CA. Consumers are
warned not to purchase or consume this product.
[May 16, 1997 (HHS News) - FDA]
Back to Top
Ephedrine Dietary Supplements
FDA proposes to limit
the amount of ephedrine alkaloids contained in dietary supplement products
and require labeling and marketing measures that give adequate warning and
information to consumers. Hundreds of illnesses and injuries associated with
the use of these products have been reported.
[June 2, 1997 (HHS News) - FDA]
Back to Top
Herbal Fen-Phen
FDA warns consumers that
"herbal fen-phen" products marketed as alternatives to the prescription
drugs phentermine and fenfluramine (commonly referred to as "fen-phen")
are considered unapproved drugs. Unapproved drugs have not been shown to be
safe or effective and may contain ingredients that have been associated with
injuries.
[November 6, 1997 ( Talk Paper) - FDA]
Back to Top
Plantain Containing Dietary Supplements
FDA warns against dietary
supplement products that may contain digitalis mislabeled as "Plantain".
FDA recently conducted an investigation on a report where a young woman experienced
abnormal heart rate with heart block after consuming a dietary supplement
containing "plantain". Laboratory analyses confirmed the presence
of digitalis.
[June 12, 1997 (Statement)
- FDA]
FDA MedWatch Website: MedWatch
Back to Top
|
