Male supplement sold at GNC franchises recalled over hidden prescription drugs

A dietary supplement sold for nearly a decade at independently owned GNC franchise stores across the United States has been pulled from shelves after laboratory testing found it secretly contained three prescription drug ingredients, including one that is not approved for use in the United States at all. Tonight We Ride, LLC, of Lakeville, Minnesota, is voluntarily recalling all lots of its Ultimate Forza Male Supplement capsules "to the consumer level," according to a company announcement posted by the Food and Drug Administration on October 24.

Testing commissioned by GNC, the retail chain that carried the product through franchise locations, turned up undeclared sildenafil, tadalafil and dapoxetine in the capsules, the notice says. Sildenafil and tadalafil are the active ingredients in the prescription erectile-dysfunction drugs Viagra and Cialis. Dapoxetine, an antidepressant in the same class as Prozac, has never been approved by the FDA for any use in the country. Their presence, undisclosed on the label, makes Ultimate Forza an unapproved and misbranded drug rather than the herbal supplement it was marketed as.

Nearly a decade on store shelves

The scale of the exposure is unusual for a single-product recall. According to the notice, Ultimate Forza was distributed from 2017 to October 1, 2026, roughly nine years, through independently owned and operated GNC franchise locations nationwide. It was not sold in GNC's corporate-owned stores. The recalled items include a ten-capsule box (item number 810208, UPC 868592000002) and a single-capsule pack (item number 810222, UPC 868592000040), both sold as blue hard-shell capsules.

The company says no illness or injury reports have reached it so far. "No adverse events or complaints have been reported to date," the notice states, though FDA recall announcements routinely caution that absence of reported harm does not mean no harm occurred, since supplement-related reactions are often not traced back to an unlabeled product.

Why the hidden ingredients matter

The health risk tied to sildenafil and tadalafil is specific and well documented: both drugs can interact dangerously with nitrate medications, such as nitroglycerin, prescribed for chest pain, and the combination can cause blood pressure to drop to dangerous levels. That risk falls disproportionately on men with diabetes, high blood pressure, high cholesterol or heart disease, the population most likely to be prescribed nitrates and, not coincidentally, a population that may also be seeking help with erectile dysfunction. Because the drugs were never listed on the label, a consumer taking Ultimate Forza alongside a nitrate prescription would have no way to know of the conflict.

Dapoxetine carries a separate concern. As a selective serotonin reuptake inhibitor, it belongs to a drug class that carries FDA-mandated warnings about increased risk of suicidal thinking and behavior in children, adolescents and young adults, even though it has never cleared the agency's approval process for any indication in the United States. Its inclusion in an unregulated capsule means consumers were exposed to a drug whose safety profile in this context has not been formally evaluated here at all.

A recurring pattern in the supplement aisle

Ultimate Forza is not an isolated case. The notice sits alongside dozens of other entries on the FDA's running page of recalls, market withdrawals and safety alerts, and the agency separately keeps a running list of public notifications about health fraud, a category dominated for years by sexual-enhancement and weight-loss products found to contain hidden drug ingredients. A 2022 review published in The Journal of Clinical Pharmacology examined the FDA's own Health Fraud Product Database and identified 1,068 unique dietary supplement products marketed between 2007 and 2021 that contained active pharmaceutical ingredients or substances the agency considers too dangerous for human use. Fifty-four percent of those products were marketed for sexual dysfunction and 35 percent for weight loss, according to the study, whose findings were summarized by its author, a University of Connecticut pharmacy professor, in an academic research brief.

The underlying regulatory gap has not changed. Dietary supplements do not require FDA approval before they reach store shelves, and manufacturers are not required to prove a product is safe before selling it. The agency can act only after a product is already on the market and typically after its own laboratory testing, or testing commissioned by a retailer, turns up a problem, which is how Ultimate Forza came to light: not through routine FDA surveillance but through GNC's third-party testing of a product its franchisees had been selling for years.

What happens now

GNC says it has stopped sales, quarantined affected inventory at franchise locations and notified customers to discontinue use and return any remaining product. Consumers who purchased Ultimate Forza are being told to stop taking it immediately and bring unopened or partially used packages back to a GNC store for a full refund. Anyone who took the product and experienced a health problem, particularly heart-related symptoms or a sudden drop in blood pressure, is advised to contact a physician.

"Consumers should stop using Ultimate Forza Male Supplement immediately."

The FDA is also directing consumers to report any adverse reaction or quality complaint tied to the product through its MedWatch safety-reporting program, which collects data the agency uses to track harm from products that fall outside normal drug oversight. GNC's customer service line, 1-877-462-4700, and email address, [email protected], are listed as points of contact for refunds, while the FDA's own consumer line is 1-888-INFO-FDA.

The recall notice, like all such company announcements the FDA posts, carries the agency's standard disclaimer that publishing it is a public service and does not amount to an endorsement of the company or product. No formal recall classification is listed in the notice, though the ingredients involved and the nine-year distribution window make this one of the broader hidden-drug cases to surface this year.