Primal Supplements Group LLC has voluntarily recalled its Primal Herbs Volume dietary supplement after FDA laboratory analysis confirmed the product contains sildenafil — the active prescription ingredient in Viagra — which was never listed on the product label. The recall applies to all orders placed between July 2 and September 19, 2025. No confirmed adverse events have been reported, but the FDA warns the hidden ingredient poses a potentially life-threatening risk to people taking certain heart medications.
What’s Being Recalled?
The recalled product is Primal Herbs Volume, an herbal dietary supplement sold in 8.5 oz round containers with green labels, marketed on the company’s website as supporting arousal, circulation, reproductive health, and overall wellness in men. The product was sold exclusively online at primalherbs.com and distributed nationwide. The recall covers all orders placed between July 2, 2025, and September 19, 2025. No lot numbers or expiration dates are listed on the product.
Why Was This Product Recalled?
FDA laboratory analysis found that Primal Herbs Volume contains sildenafil — the active pharmaceutical ingredient in the prescription drug Viagra, which is approved by the FDA only for use under the supervision of a licensed healthcare provider. Sildenafil was not declared anywhere on the product’s ingredient label, meaning consumers had no way of knowing they were ingesting a prescription-strength drug. The FDA warns that sildenafil can interact with nitrates found in common prescription medications — such as nitroglycerin — and cause a sudden, dangerous drop in blood pressure that can be life-threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease are especially at risk, as these individuals frequently take nitrate-based medications. Dietary supplements cannot legally be marketed with undeclared pharmaceutical drug ingredients.
What Should You Do?
If you ordered Primal Herbs Volume online between July 2, 2025, and September 19, 2025, stop using the product immediately. Contact Primal Supplements Group LLC by email at [email protected] and include your order number. The company is offering customers a choice of a complimentary replacement shipment or full store credit, along with return instructions. If you take nitrate medications for a heart condition, diabetes, high blood pressure, or high cholesterol, consult your healthcare provider right away about any potential exposure.
