- The FDA announced a recall of sexual enhancement products containing undeclared prescription drugs like Viagra and Cialis due to health and safety risks.
- The March 16 recall was issued by the products’ distributor Pyramid Wholesale following an investigation by the California Department of Health.
- CDPH identified 11 sexual enhancement supplement products containing prescription drugs that were not disclosed on product labeling and issued a safety warning.
- No adverse events have been reported, but Pyramid Wholesale advised consumers to discontinue use.
The Food and Drug Administration (FDA) announced a recall of sexual enhancement supplement products containing undeclared prescription drugs like Viagra.
Pyramid Wholesale issued the March 16 recall after an investigation by the California Department of Public Health (CDPH) determined its sexual enhancement products were unsafe.
CDPH identified multiple dietary supplements containing undeclared prescription drugs, including Sildenafil (Viagra) and Tadalafil (Cialis), which could have adverse effects like misuse and interactions with other medications, and posted a consumer warning on its website, a CDPH representative told Healthline.
The recall includes 11 different products — “Spanish Fly” and “Samurai-X,” among others — that varied in dosage, with some marketed specifically for female or male sexual enhancement.
The products were sold in bulk to retailers and other distributors in California and surrounding areas. The full list of products can be found on the FDA’s website.
No adverse events have been reported, but Pyramid Wholesale advised consumers to stop using the products immediately. “We deeply regret any worry or inconvenience this recall may have caused,” the company said in a statement.
Health risks of undeclared drug ingredients
All sexual enhancement products involved in the Pyramid Wholesale recall contained undeclared prescription drugs, CDPH found.
“Undeclared prescription drugs refer to medications or pharmaceutical compounds that are present in a product without being listed on the product label or disclosed to consumers,” Dr. Ashley Tapscott, board certified urologist and advisor to Marius Pharmaceuticals in North Carolina, told Healthline.
“These drugs are often included in dietary supplements, herbal products, or other health supplements without proper regulation or oversight.”
When drugs are not listed in ingredient statements it means the products have not undergone rigorous testing, which may raise the risk of serious adverse events, such as:
- misuse and overuse
- drug interactions
- allergic reactions
- contraindications with health conditions
OTC sexual supplements are an easy, but not always safe choice
Consumers may opt for over-the-counter (OTC) sexual enhancement products over visiting an OB-GYN, urologist, or therapist for any number of reasons, convenience being a likely factor.
For some individuals, sexual health discussions with healthcare professionals may be uncomfortable or stigmatizing, and the anonymity of OTC products could seem more appealing.
And for many people, especially those without insurance, medical treatment may come at a higher cost compared to trying OTC supplements.
“These supplements are easily accessible without the need for a doctor’s visit or prescription, offering convenience for individuals seeking a quick solution to their sexual health concerns,” Tapscott said.
“Lack of awareness or education about the risks associated with unregulated supplements may lead individuals to believe they are safe and effective based on marketing claims or anecdotal evidence.”
Treatments for sexual dysfunction, erectile dysfunction
There is limited scientific evidence to support the health claims of many sexual enhancement supplements because, as with other dietary supplements, they are largely unregulated by the FDA.
As such, supplement products claiming to aid sexual dysfunction or improve erectile dysfunction (ED) often lack oversight or consultation with medical professionals.
“Unregulated supplements may claim to enhance testosterone levels through various ingredients. However, the actual effects can vary widely, and the safety of these supplements in regulating testosterone is often questionable,” Tapscott said.
Most experts recommend addressing health concerns with a medical professional who can develop an appropriate treatment plan and ensure patients receive the right medication.
Tapscott noted for low testosterone specifically, testosterone replacement therapy (TRT), which is FDA-approved, can promote sexual enhancement and also help treat erectile dysfunction in males with low testosterone.
Of course, Viagra and Cialis, which when used as prescribed and directed, can be effective, science-backed treatments for ED.
“It’s very important to find legitimate sources for all medications — even compounding pharmacies can’t always be trusted,” Tapscott said.
“Make sure the drugs you are taking are FDA-approved. If you have any questions or concerns about medications or prescription drugs, it’s important to consult with a qualified healthcare professional to ensure your health and safety.”
Takeaway
The FDA announced a recall of 11 sexual enhancement dietary supplement products distributed by Pyramid Wholesale.
The recall was prompted by a California Department of Public Health investigation, which identified prescription drugs like Viagra and Cialis that were not included in the product labeling.
No adverse events were reported, but consumers should discontinue using these products immediately.
