Primal Supplements Group LLC announced on Mar. 11 a voluntary nationwide recall of its Primal Herbs Volume product after the U.S. Food and Drug Administration (FDA) found it contained undeclared sildenafil, the active ingredient in Viagra.
The recall affects all orders placed between July 2 and September 19, 2025, through the company's website. The FDA confirmed that laboratory analysis detected sildenafil in the product, which was not listed on the label. Sildenafil is only approved for use under medical supervision and can cause dangerous interactions with certain prescription drugs, especially those containing nitrates.
According to the company, "Customers who placed an order between July 2, 2025 and September 19, 2025, on the website: primalherbs.com, should discontinue use immediately." The affected product comes in 8.5 oz round containers with green labels.
Sildenafil may interact with medications such as nitroglycerin and could lower blood pressure to unsafe levels. People with conditions like diabetes, high blood pressure, high cholesterol or heart disease are often prescribed nitrates and may be at increased risk if they consume this supplement without knowing it contains sildenafil.
Consumers who purchased Primal Herbs Volume during the specified period are advised to stop using it and contact Primal Supplements Group LLC at hello@primalherbs.com or +1 (856) 420-6117 for a replacement or store credit. The company said it is committed to ensuring product quality and customer safety: "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."
Adverse reactions or quality problems related to this product can be reported to the FDA’s MedWatch Adverse Event Reporting program online or by mail or fax.
