Nationwide Supplement Recall After FDA Discovers 'Hidden Drug Ingredient' - Newsweek

Nov 06, 2024

Two dietary supplements aimed at supporting men's health have been recalled after they were found to contain "hidden drug ingredients," the Food and Drug Administration (FDA) reports.

The unlisted ingredients can cause "life threatening" drops in blood pressure when used in combination with other prescription drugs, the agency warns.

The voluntary recall was initiated by California-based supplement company Boulla LLC on November 4 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 enhance male performance and energy. However, neither sildenafil nor diclofenac are listed on their packaging.

The table below shows the products that were affected:

"Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening," the FDA said in a statement on November 5.

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

The agency added that, among the products' target demographic, adult males who use nitrate-based medication to manage heart conditions are the most at risk.

As for diclofenac, the ingredient may also interact with other medications, but it can also cause side effects in its own right.

"Use of products with undeclared diclofenac may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines," the FDA said in a statement.

Boulla LLC have notified its distributors and consumers of the incident and is arranging for the return of all recalled products.

"Consumers that have ZoomMax or ZapMax capsules lot number YZM240406 should stop using the product," the FDA said. "Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product."

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

The FDA warned that ZoomMax and ZapMax, as well as many other dietary supplements, are classed as "unapproved" drugs and have not undergone the same level of safety and efficacy scrutiny as approved pharmaceutical productions.

"FDA is unable to test and identify all products marketed as dietary supplements that have potentially harmful hidden ingredients," the administration said in a statement on June 20 after the previous recall. "Consumers should exercise caution."

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