Supplement Recalled Across the U.S. After Undeclared Sildenafil Is Found, Raising Serious Health Risks

Sildenafil supplement recall due to safety concerns

Potentially dangerous drug interaction

Nationwide voluntary recall

A supplement sold nationwide has been removed from the market after tests detected undeclared sildenafil in its formula.

The measure was announced by Primal Supplements Group LLC after a laboratory analysis confirmed the presence of the substance.

The product involved in the sildenafil supplement recall is Primal Herbs Volume, distributed in 237-gram round containers with a green label.

The recall applies to all orders made between July 2 and September 19, 2025, through the brand’s official website.

Sildenafil Undeclared on the Label

Sildenafil Supplement Recall Over Serious Health Risk-Photo: Shutterstock

Sildenafil is the active ingredient in Viagra, which is approved by the U.S. Food and Drug Administration to treat erectile dysfunction with a prescription.

Its use is regulated and requires medical supervision due to potential side effects and contraindications.

The presence of this compound in a supplement without being declared on the label poses a significant risk for consumers, which is why authorities issued the sildenafil supplement recall.

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This is especially concerning because sildenafil may interact with nitrate-based medications used to treat heart conditions.

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Risks of Undeclared Sildenafil for People With Chronic Conditions

Combining sildenafil with medications that contain nitrates—such as Nitroglycerin—can cause a dangerous drop in blood pressure.

This risk is higher for individuals with conditions such as diabetes, high blood pressure, high cholesterol and heart disease.

Because of these risks, the company asked customers who purchased the product during the affected dates to stop using it immediately.

Consumers are also advised to consult a doctor if they experience any adverse effects related to the supplement.

Instructions for Affected Consumers

Primal Supplements Group LLC stated that customers who purchased the product during the specified period should contact the company to arrange a return.

Customers may choose to receive a free replacement shipment, or full store credit.

The company provided the email hello@primalherbs.com and phone number +1 (856) 420-6117 to assist customers.

It also pledged to provide simple instructions for returning the product as part of the sildenafil supplement recall process.

Reporting Adverse Effects to the FDA

Health authorities reminded consumers that any adverse reactions or product quality problems can be reported through the FDA’s MedWatch program.

Consumers can submit reports online, by mail, or by fax, using official forms available on the FDA’s website.

The company stated that the recall is voluntary and that it is treating the issue seriously.

In its statement, the company emphasized its commitment to product quality and consumer safety while updates on the situation continue.