Herbal supplement taken by thousands recalled after FDA finds it is tainted with erectile dysfunction drug
An herbal supplement has been urgently recalled after products were found to contain ingredients used in erectile dysfunction medications.
Primal Supplements Group LLC of New Mexico is voluntarily recalling all orders of Primal Herbs Volume placed between July 2 and September 19, 2025, because an FDA analysis found the supplements contain sildenafil, the active ingredient in Viagra and Revatio.
Sildenafil, which is used to treat erectile dysfunction by relaxing blood vessels and increasing blood flow, was not declared on the ingredient labels.
The recall affects orders placed on the Primal Herbs website. Products were packaged in 8.5oz round containers with green labels. It’s unclear exactly how many orders were placed during the indicated time period, but the company’s website says the product is ‘trusted by over 50,000 men.’
FDA approval of Viagra is ‘restricted to use under the supervision of a licensed health care professional,’ according to the agency.
No illnesses or adverse effects have been reported, but the FDA warned that undeclared sildenafil may interact with compounds called nitrates that are found in drugs used to treat high blood pressure, heart disease and diabetes.
Nitrates widen the blood vessels to reduce the heart’s workload, but sildenafil on top of those may ‘lower blood pressure to dangerous levels,’ the FDA said.
FDA officials said people who ordered the medication during the specified time period ‘should discontinue use immediately.’
Supplements marked to men have been recalled for containing undeclared sildenafil, the active ingredient in Viagra and Revatio (stock image)
Primal Supplements Group said in its recall notice: ‘Primal Herbs is conducting this recall voluntarily and takes this matter very seriously. We apologize 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.’
An FDA classification has not been given for this recall.
Consumers who purchased the products should contact the team at hello@primalherbs.com with their order number. ‘We’ll take care of you right away with your choice of a complimentary replacement shipment or full store credit, along with simple return instructions,’ the brand said.
Adverse reactions or quality control problems associated with use of the recalled products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Primal Herbs Volume is a liquid mixer that claims to strengthen erections and combat erectile dysfunction, though there is no mention of sildenafil on the labels.
Pictured above is the recalled product, which the FDA has recommended consumers to stop using immediately
Viagra (pictured in the above stock image) which is used to treat erectile dysfunction by relaxing blood vessels and increasing blood flow. The FDA warned that undeclared sildenafil may counteract with compounds called nitrates that are found in drugs used to treat high blood pressure, heart disease and diabetes
It claims to contain Maca, Siberian ginseng, American ginseng, red ginseng, pollen, oats, tribulus terrestris, ginger, ginkgo biloba, mulberry molasses, carob, flower honey, glucose syrup, galanga root, cinnamon, nettle, pumpkin, kola nut, aroma and royal jelly.
No side effects are listed on the label or on the company’s website. ‘If you have a medical condition, are taking other medications, or have concerns, consult your healthcare professional before use,’ the website states.
Each 8.5oz jar costs $59 with a regular subscription or $69 as a one-off purchase.
About 25 million men in the US have reported taking Viagra at least once, and roughly 30 million men suffer from erectile dysfunction, which may be caused by aging or pre-existing conditions such as diabetes or obesity.
The medication is available via prescription only.
