Primal Herbs Recalls Supplement for Undeclared Sildenafil
Class I Recall — Most Serious
This is a Class I recall — the most serious type. Products covered by this recall may cause serious health consequences or death.
Primal Supplements Group LLC has announced a voluntary recall of its Primal Herbs Volume dietary supplement due to the presence of undeclared sildenafil. This recall affects all orders placed between July 2 and September 19, 2025. Sildenafil is the active ingredient in Viagra, a prescription medication for erectile dysfunction, and its presence in the supplement poses potential health risks.
Affected Products:
- Primal Herbs Volume dietary supplement
- Packaged in 8.5 oz round containers with green labels
- Orders placed between July 2 and September 19, 2025, on primalherbs.com
Reason for Recall:
The recall was initiated after FDA laboratory tests confirmed the presence of sildenafil, which is not listed on the product label. Sildenafil can interact with nitrates found in some prescription medications, potentially leading to dangerously low blood pressure. This is particularly concerning for individuals with diabetes, high blood pressure, high cholesterol, or heart disease.
Consumer Action:
Customers who purchased the affected product should stop using it immediately. They are advised to contact Primal Herbs at [email protected] with their order number to receive a complimentary replacement or full store credit. For further assistance, consumers can call +1 (856) 420-6117.
Health Risks:
There have been no reported illnesses related to this recall. However, consumers who experience any adverse reactions should contact their healthcare provider. Adverse events can also be reported to the FDA’s MedWatch Adverse Event Reporting program.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). Primal Herbs is committed to consumer safety and apologizes for any inconvenience caused by this recall.
Where Products Were Sold
This recall affects products distributed nationwide across the United States.