July 2, 2022

FDA Warns Companies That Make Coco Loko and Legal Lean as Unapproved New Drugs

The FDA is warning makers and manufacturers of two products, Legal Lean Syrup, a drink, and Coco Loko, a "snortable" chocolate powder, for selling unapproved new drugs and misbranded drugs. These products are promoted as alternatives to street drugs. The government has sent a warning letter to one company about this problem. Claims made in the promotional materials for the products demonstrate they are intended to be used as alternatives to street drugs. These products, as labeled and marketed, "may pose safety concerns," according to the press release. The FDA is concerned that these products encourage drug abuse in individuals, including minors. These street drug alternatives are used for recreational purposes to affect psychological states. FDA Commissioner Scott Gottlieb said … [Read more...]

Nutra Labs Recalls Dietary Supplements for Undeclared Drugs

Nutra Labs is voluntarily recalling two dietary supplements because they contain sildenafil, the active pharmaceutical ingredient in an FDA approved product used for erectile dysfunction. This makes these supplements unapproved new drugs. No illnesses or reactions have been reported to date in connection with this problem. The recalled products are Bull in 1800 mg capsules with a production date of 05/08/2016 and Chao Jimengnan 150 mg tablets with lot #20151018. FDA analysis found that Bull had contamination of 0.026mg/capsule, and 70.46 mg/table for Chao Jimengnan. The expiration dates are 05/07/2019 for Bull and 10/2017 for Chao Jimengnan. This drug can be dangerous because its active ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin. … [Read more...]

New Kopi Jantan Natural Herbs Coffee Recalled for Undeclared Drugs

Bestherbs Coffee LLC is voluntarily recalling all lots of New of Kopi Jantan Tradisional (sic) Natural Herbs Coffee, a dietary supplement, because it contains an undeclared ingredient and undeclared milk. Desmethyl carbodenafil is structurally similar to sildenafil, the active ingredient in Viagra, which makes this product an unapproved drug. That ingredient can interact with nitrates found in prescription drugs and lower blood pressure to dangerous levels. The product also contains undeclared milk, which can sicken those who are allergic to that ingredient. New of Kopi Jantan Tradisional Natural Herbs Coffee is used as a male enhancement and is packaged in 13 gram red packs, with UPC number 557205060083. Each box contains 25 packets. Bestherbs Coffee LLC distributed this product … [Read more...]

Sten Z and M1 Alpha Supplements Recalled for Steroids

Andropharm is recalling all lots of Sten Z and M1 Alpha capsules because they contain derivatives of anabolic steroids. This makes these products unapproved drugs, for which safety has not been established. No reports of adverse reactions have been received to date. These product may cause elevated blood pressure, aggressive behavior, male infertility. Those with conditions such as heart disease, liver disease, or prostate issues can be at higher risk. Sten Z and M1 Alpha capsules are marketed as dietary supplements and promoted to increase, sustain, and strengthen muscularity. The two products were packaged as capsules in 60 count bottles with the UPC number 642125502948 (Sten Z) and UPC number 642125502924 (M1 Alpha). These products were sold through retailers nationwide in the … [Read more...]

Ultra-Sten and D-Zine Supplements Recalled for Anabolic Steroids

Hardcore Formulations is recalling all lots and expiration dates of Ultra-Sten and D-Zine capsules because they contain anabolic steroids. The presence of these drugs render them unapproved drugs and subject to recall. No illnesses or adverse effects have been reported to date. Ultra-Zen contains methylstenbolone and D-Zine contains dymethazine. These drugs can cause serious liver injury and also injure the kidneys, cause an increased risk of heart attack and stroke, elevated blood pressure, and other issues. Ultra-Sten and D-Zine capsules are marketed as dietary supplements for body-building and are packaged  in 90-count bottles, with the bar code 7-48252-68763-0 (Ultra-Sten); 7-48252-86193-1 (D-Zine) and sold through retailers nationwide in the USA. This recall applies to all lot … [Read more...]

Tri-Ton Recalled for Unapproved Drugs

Dynamic Technical Formulations is voluntarily recalling all lots of Tri-Ton, a dietary supplement. FDA lab analysis found that it contains mandarine and ostarine, which are selective androgen receptor modulators (SARMs) that are considered unapproved drugs and anabolic steroid-like substances. Use of those substances may cause acute liver injury. Other long term adverse health effects in men, women, and children include male infertility, short stature in children, a higher risk of misusing other drugs and alcohol, and increased risk of heart attack, stroke, and death. The recalled product, Tri-Ton, was sold in 90 count bottles. All lot numbers and expiration dates are recalled. It was sold through retailers nationwide. Shipment was from June 2016 to March 2017. Stop using this … [Read more...]

GEC Laxoplex Recalled for Anabolic Steroids

Genetic Edge Compounds is voluntarily recalling all lot codes of GEC Laxoplex that were distributed between February 2, 2015 and May 2, 2017 because they are tainted with anabolic steroids and steroid-like substances. This makes the supplement an unapproved drug. There have been no reports of adverse effects received to date. Anabolic steroids an cause acute liver injury and can cause other adverse health problems, including a higher predilection to misuse other drugs and alcohol, and increased risk of heart attack, stroke, and death. The recalled product is GEC Laxoplex. It is marketed as a dietary supplement and sold as a muscle enhancing agent. It is packaged in a white plastic bottle containing 60 capsules. The UPC number is 0058049984. It was distributed nationwide through … [Read more...]

Organic Herbal Supply Recalls Dietary Supplements for Undeclared Drugs

Organic Herbal Supply is recalling all lots of their male and female sexual enhancement dietary supplements  because FDA analysis found the products contain Tadalafil. That is an FDA-approved drug that is used under prescription. Organic Herbal Supply is also recalling Zrect for Women and LabidiaMAX because they contain Flibanserin, an FDA approved drug for Hypoactive Sexual Desire Disorder in women. No illnesses have been reported to date in connection with these issues. The Uproar, Cummor, Zrect, Monkey Business, Xrect, Rectalis, Tornado, Zdaily, BigNHard, Enhancerol Natural Male Enhancement capsules are packaged in 2, 4, and 10 count packages and sold nationwide. Zrect for women and LabidaMAX were packaged in 30 count packages and sold nationwide through Amazon.com and through … [Read more...]

LaBrit’s Body Health Capsules Recalled for Undeclared Drug

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...]

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