Nationwide recall of dietary supplements after FDA discovers “hidden drug ingredient.”

Two men’s health supplements have been recalled after they were found to contain “hidden drug ingredients,” the Food and Drug Administration (FDA) reports.

The ingredients not listed can cause “life-threatening” drops in blood pressure when combined with other prescription medications, the agency warns.

The voluntary recall was initiated on November 4 by California-based dietary supplement company Boulla LLC after they were found to contain sildenafil – the active ingredient in Viagra – and diclofenac – an FDA-approved drug used to treat pain and inflammation.

The recalled products – ZoomMax and ZapMax – are marketed as dietary supplements to increase male performance and energy. However, neither Sildenafil nor Diclofenac are listed on the packaging.

The following table shows the affected products:

“Consuming products containing undeclared sildenafil may interact with nitrates found in some prescription medications (such as nitroglycerin) and cause a significant decrease in blood pressure, which may be life-threatening,” the FDA said in a Nov. 5 statement.

“People with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.”

The agency added that among the products’ target population, adult men taking nitrate-based medications to treat heart disease were most at risk.

As for diclofenac, the ingredient can also interact with other medications, but can also cause side effects on its own.

“Use of products containing undeclared diclofenac may cause an increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal harm such as bleeding, ulceration, and fatal perforation of the stomach and intestines,” the FDA said in a statement.

Boulla LLC has notified its dealers and consumers of the incident and is initiating the return of all recalled products.

“Consumers who possess ZoomMax or ZapMax capsules with lot number YZM240406 should discontinue use of the product,” the FDA said. “Consumers should contact their doctor or healthcare provider if they have experienced any problems that may be related to taking or using this medicine.”

The latest recall comes just two months after Boulla LLC issued another voluntary recall for its Boom Max capsules, which also contained undeclared sildenafil.

The FDA warned that ZoomMax and ZapMax, as well as many other dietary supplements, are considered “unapproved” drugs and have not undergone the same level of safety and effectiveness testing as approved drug productions.

“The FDA is unable to test and identify all products marketed as dietary supplements that contain potentially harmful hidden ingredients,” the government said in a June 20 statement following the previous recall. “Consumers should exercise caution.”

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