Albuquerque, New Mexico — A popular herbal supplement marketed for male performance is being recalled after federal officials discovered it contains an undeclared prescription drug ingredient, raising potential health risks for consumers.
Primal Supplements Group LLC has issued a voluntary recall of its Primal Herbs “Volume” product after the U.S. Food and Drug Administration (FDA) found it contains sildenafil, the active ingredient used in prescription Viagra.
“The ingredient sildenafil was not listed on the product label, prompting safety concerns from federal health officials.”
Hidden drug ingredient raises safety concerns
Sildenafil is commonly used to treat erectile dysfunction, but it is only approved for use under medical supervision.
Health officials warn that consuming it unknowingly can be dangerous, especially for individuals with certain medical conditions.
“Undeclared sildenafil can pose serious health risks, particularly when taken with certain medications.”
Risk of dangerous drug interactions
According to the FDA, the biggest concern involves interactions with nitrate medications, which are commonly prescribed for heart conditions.
These include drugs such as nitroglycerin, and combining them with sildenafil can lead to:
- Dangerously low blood pressure
- Dizziness or fainting
- Potentially life-threatening complications
People with conditions like:
- Heart disease
- High blood pressure
- Diabetes
- High cholesterol
may be at higher risk, as they are more likely to be taking nitrate-based medications.
Product sold online with herbal claims
The recalled product was sold through primalherbs.com and packaged in round 8.5-ounce containers with green labels.
It was marketed as a natural supplement to support men’s “performance and drive.”
Ingredients listed on the label include:
- Maca
- American ginseng
- Siberian ginseng
- Ginkgo biloba
- Ginger
However, the presence of an undisclosed pharmaceutical ingredient has raised concerns about product transparency and safety.
Consumers urged to stop using product immediately
Officials are advising anyone who purchased the supplement between July 2 and September 19, 2025, to stop using it right away.
“Consumers should discontinue use immediately and consult a healthcare provider if they experience any adverse effects.”
The company has stated that affected customers can receive:
- A free replacement product, or
- Full store credit
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Company issues apology
In its recall notice, the company said it is taking the situation seriously and emphasized its commitment to consumer safety.
“We apologize for the inconvenience and remain committed to ensuring product quality and customer well-being.”
Ongoing concerns over supplement safety
This recall highlights ongoing concerns about unregulated or mislabeled supplements, particularly those sold online.
Health experts often warn that some products marketed as “herbal” or “natural” may contain undisclosed pharmaceutical ingredients.
“Consumers are encouraged to verify supplements and consult professionals before use.”
As the recall moves forward, federal officials continue to monitor the situation and urge consumers to stay informed.
What are your thoughts on this supplement recall and safety concerns? Share your thoughts respectfully in the comments and join the conversation with other readers.
