More Dietary Supplements Recalled for Undeclared Drugs

Five brands of dietary supplements billed as ways to boost sexual stamina and energy and made by Nature & Health Co. of Brea, Ca. are being recalled because the products contain the active ingredients found in erectile dysfunction medications, making them unapproved drugs.

Supplements sold under the brand names LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, and Herbal Disiac are involved in the Food and Drug Administration recall. The products were sold in retail stores in California, Georgia, Illinois, Texas, and Ohio, the FDA said.

No reports of consumer injuries caused by the undeclared pharmaceutical ingredients have been received so far, officials said.

Other Recent Supplement Recalls

Earlier this week, Libipower Plus products were recalled after the pills were found to contain tadalafil. The products were sold in single-capsule blister packs through distributors and in retail stores across California.

In June, Stamina-RX brand dietary supplements were recalled because they were found to contain benzamidenafil, a drug that mimics the ingredients in some erectile dysfunction drugs, and did not declare the ingredient on the labeling. In both cases, the ingredients were not listed on the products’ labeling, presenting a risk of severe injury to users.

Six Products Recalled

The Nature & Health Co. dietary supplement products being recalled, their retail size, and the active pharmaceutical ingredient they were found to contain include:

LibieXtreme: 1 capsule packet, aminotadafil

Y-4ever: 1 capsule packet, sulfoaidenafil

Libimax X Liquid: 1 fl. Oz. packet, aminotadafil

Powermania liquid: 1 fl. Oz. packet, sulfoaidenafil

Herbal Disiac: 40-capsule bottle, tadalafil

Powermania: 1 capsule packet, sulfoaidenafil

FDA testing of samples of the supplements found they contained either tadalafil, aminotadalafil, or sidenafil, which are active ingredients found in FDA-approved drugs for erectile dysfunction. The supplements containing the drugs do not declare their presence on the product labeling, which can cause a life-threatening drop in blood pressure and other complications for users also taking nitrates.

The undeclared ingredients can interact with nitrates found in prescription drugs such as nitroglycerin, which can drop blood pressure to dangerously low levels, the FDA warned. Patients with diabetes, high cholesterol, high blood pressure, or heart disease often take nitrates.

The supplements may also cause adverse side effects, such as headache and flushing.

Consumers who have the Nature & Health Co. supplements in their possession should return any unused products to the retail location where they purchased the items for a full refund or a partial refund for the unused portion.

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