Envy Me is recalling LaBri's Body Health Atomic dietary supplement marketed for weight loss because it contains undeclared sibutramine. That is a controlled substance that was removed from the market in October 2010 for safety reasons. Sibutramine can substantially increase blood pressure and/or pulse rate in some patents and can present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. No reports of illness have been received to date by the company, but the FDA has reported one adverse event that occurred in June 2016. The products were sold nationwide through internet sales beginning in early 2015. Consumers should stop using the product immediately and throw it away in accordance with local ordinances for … [Read more...]
A&H Focal Recalls 29 Dietary Supplements
A&H Focal is recalling 29 products marketed as dietary supplements because they may contain undeclared erectile dysfunction ingredients. They contain PDE-5 Inhibitors such as sildenafil, tadalafil, or vardenafil. That means these supplements are considered unapproved drugs. The active ingredients are a threat to consumers because they an interact with nitrates found in some prescription drugs and can lower blood pressure to dangerous levels. The recalled products include Black Ant (4600 mg), Indian God Lotion, Evil Root (1200 mg), Germany Black Gold (2800 mg), Germany Niubian (3000 mg), Hard Ten Days (4500 mg), Lang Yi Hao (Chaonogsuopian) (500 mg), Gold Vigra, Clalis, Ye Lang Shen (5000 mg), and Zhansheng Weige Chaoyue Xilishi (2000 mg). Also recalled are Zhonghua Niubian (2000 … [Read more...]
XtraHRD Natural Male Enhancement Capsules Recalled
Organic Herbal Supply is recalling all lots of XtraHRD Natural Male Enhancement Capsules. FDA analysis fond the product contains Tadalfil, an FDA approved drug used as treatment for male Erectile Dysfunction. This ingredient is not listed on the label. Tadalafil can interact with nitrates found in some presciption drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Anyone who diabetes, high blood pressure, high cholesterols, or heart disease often takes nitrates. The recalled product is marketed as a dietary supplement. It is packaged in 2, 4, and 10 count packages and is sold nationwide. If you purchased this product, do not use it. Take it back to the store where you purchased it for a full refund. No adverse events have been reported. You can report … [Read more...]
Megajex Dietary Supplement Recalled for Unapproved Drugs
MS Bionic is recalling all lots of Megajex Natural Male Sex Enhancer capsules. this product contains Tadalafil and Sildenafil, FDA approved drugs used as treatment for ED. This product could be harmful because these undeclared drugs may lower blood pressure to dangerous levels. Anyone with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The drugs in this product can interact with nitrates. The product is marketed as a dietary supplement for erectile dysfunction. It is packaged in 20 count bottles and was sold nationwide. If you purchased this product, do not take it. Contact your physician if you have experienced any problems that may be related to taking or using this product. Return the product to the place of purchase or take it to a drug … [Read more...]
Supreme Slim 5.7 Contains Hidden Drugs
The FDA is warning the public not to purchase or use Supreme Slim 5.7, a dietary supplement that is sold for weight loss on some web sites and may have been sold in retail stores. It contains phenolphthalein and sildenafil, two undeclared drugs. Phenolphthalein is not approved for use and it may be associated with an increased risk of cancer. Sildenafil is the active ingredient in the prescription drug Viagra. It may interact with nitrates found in some prescription drugs, and can lower blood pressure to dangerous levels. If you purchased this product, do not consume it. Take it to the drug disposal program in your area or take it back to the place of purchase for a refund. You can report adverse effects from taking this product or any dietary supplement to the FDA. Use the FDA's … [Read more...]
Skinny Bee Diet Recalled for Unapproved Drugs
Love my Tru Body of Georgia is recalling all of its Skinny Bee Diet pills after FDA testing found it contained sibutramine, desmethylsibutramine, and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Desmethylsibutramine is an active metabolite of sibutramine. Sibutramine and its active metabolites 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. Phenolphthalein was previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is no longer marketed in the U.S. These undeclared ingredients make this product an unapproved new drug … [Read more...]
Dream Body Weight Loss Supplements Recalled for Unapproved Drug
Dream Body Weight Loss of Grand Prairie, TX has issued a recall for weight loss supplements because they contain sibutramine,an unapproved drug. Consumers should not use the recalled products Dream Body Extreme Gold 800mg 30 gold capsules, Dream Body 450mg 30 white capsules, and Dream Body Advanced 400mg 30 purple capsules as they could cause serious health issues. The U. S. Food and Drug Administration (FDA) tested the products and found Dream Body Extreme 800mg Gold, Dream Body 450mg and Dream Body Advanced 400mg to contain sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine increases blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, … [Read more...]
FDA Targets Internet Sales of Illegal Prescription Meds
The FDA, in partnership with international regulatory and law enforcement agencies, took action in June against 4,402 websites that illegally sell potentially dangerous, unapproved prescription drugs to U.S. consumers. The effort, led by INTERPOL, was part of Operation Pangea IX. George Karavetsos, director of the FDA's Office of Criminal Investigations, said, "preventing illegal internet sales of dangerous unapproved drugs is critical to protecting consumers' health. Operation Pangea IX demonstrates the FDA's continuing commitment to stand united with our international partners to protect consumers in the United States and throughout the world from criminals who put profit above the health and safety of consumers." The action ran from May 31 to June 7, 2016. Extensive … [Read more...]
SOS Telecom Recalls Unapproved Drugs Sold as Dietary Supplements
SOS Telecom is recalling unapproved drugs marketed and sold as dietary supplements. All lots of these products are recalled because they contain Sildenafil, a PDE-5 inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction. SIldenafil can interact with nitrates in some prescription drugs and can lower blood pressure to dangerous levels. The recalled products are Tiger-X, lot number 9236999, with best use by date of 12/16/2016. It is sold in 1 capsules per pack/24 single packs per box. Also recalled is Ninja-X with lot number 7920888 and best use by date of 6/31/2018. It is also sold in ` capsules per pack/24 single packs per box. Ginseng Power-X, with lot number 7788965 and best use by date of 10/15/2018 is also recalled .That product is sold in 1 … [Read more...]
Dietary Supplement Undisputed Recalled
Nubreed Nutrition is voluntarily recalling all lot codes of a dietary supplement called "Undisputed™", which contains Acacia rigidula. This supplement is marketed as a "pre workout powerhouse." Acacia rigidula is a shrub that grows in the southwest. Its addition may mask the addition of BMPEA, a dangerous synthetic amphetamine. BMPEA is classified as a doping agent by the World Anti-Doping agency. This drug has never been tested on people. Animal tests has shown that it an dangerously increase blood pressure, and it is addictive. In addition, Acacia rigidula doesn't meet the definition of a dietary ingredient and the product is therefore an unapproved new drug. Undisputed™ was sold to distributors, wholesalers, retail stores, and direct to consumers, but was discontinued by … [Read more...]
