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FDA recalls herbal supplement containing undeclared Viagra ingredient

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FDA recalls herbal supplement containing undeclared Viagra ingredient

An herbal supplement sold online is being recalled because it contains the active ingredient used in Viagra.

New Mexico-based Primal Supplements Group LLC is voluntarily recalling certain units of its Primal Herbs “Volume” sexual enhancement product because it contains sildenafil, according to a notice released Wednesday by the U.S. Food and Drug Administration (FDA).

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Sildenafil is the active ingredient in the prescription drug Viagra, which is used to treat erectile dysfunction. The ingredient was not listed on the product’s label, the FDA said.

Health officials warn the undeclared drug could pose risks for some consumers.

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primal-herbs-supplement-recall

The Primal Herbs “Volume” sexual enhancement supplement is being recalled after regulators said it contains undeclared sildenafil, the active ingredient in Viagra. (U.S. Food and Drug Administration / Unknown)

Sildenafil can interact with medications that contain nitrates, such as nitroglycerin, potentially causing dangerously low blood pressure.

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People with conditions like heart disease, diabetes, high blood pressure or high cholesterol often take nitrate medications and could face higher risks, the agency said.

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Boxes of Viagra

Boxes of Viagra are seen on the shelves of a pharmacy. (Leon Neal/Getty Images / Getty Images)

The recalled supplement was sold through primalherbs.com and packaged in round, 8.5-ounce containers with green labels.

Consumers who purchased Primal Herbs “Volume” between July 2 and Sept. 19, 2025, are urged to stop using the product immediately.

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The company says customers who bought the product during the affected timeframe can receive a complimentary replacement shipment or full store credit.

FRITO-LAY RECALLS MISS VICKIE’S CHIPS OVER POTENTIALLY ‘LIFE-THREATENING’ ALLERGEN RISK

Viagra tablets

A blister pack containing Pfizer’s 0.50mg Viagra tablets. (Peter Dazeley/Getty Images / Getty Images)

Ingredients in the product marketed to support men’s “performance and drive” include maca, American ginseng, Siberian ginseng, ginkgo biloba and ginger, according to the Primal Herbs website.

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“Primal Herbs is conducting this recall voluntarily and takes this matter very seriously,” the announcement noted. “We apologise for the inconvenience and concern this recall may cause our customers. Our company is committed to ensuring the quality of our products and the well-being of our consumers.”

Primal Herbs did not immediately respond to FOX Business’ request for comment.

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David A. Johnson is founder and principal of Endurance Capital Management, a New Jersey Limited Liability Company. As an investor entrepreneur, David invests in stocks, bonds, options, ETFs, REITs, real estate, closed end funds and alternative investment funds such as hedge funds and private credit. With over 30 years’ experience in investing, David holds a Master of Science (MS) Degree in Finance, with a concentration in Investment Analysis, from Boston University, a Certificate in Financial Planning, and a Master’s in Business Administration (MBA) from Fordham University.

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