The National Agency for Food and Drug Administration and Control (NAFDAC) has announced a voluntary recall of all batches of the male enhancement dietary supplement MR.7 SUPER 700000 capsules, citing serious safety concerns.
The agency announced this on its official X handle on Monday the agency said the recall followed an analysis conducted by the U.S Food and Drug Administration (FDA), which found that the product contains undeclared active ingredients.
According to NAFDAC, laboratory analysis revealed the presence of Sildenafil and Tadalafil in the capsules.
The agency explained that both substances are phosphodiesterase (PDE-5) inhibitors used in approved medications for the treatment of erectile dysfunction but must not be included in products marketed as dietary supplements.
NAFDAC warned that the presence of the undeclared ingredients renders the product an unapproved drug whose safety and efficacy have not been established.
“Products containing sildenafil or tadalafil cannot be marketed as dietary supplements and could pose serious health risks,” the agency said.
The regulator noted that consumption of the capsules could interact dangerously with nitrate-based prescription medications such as Nitroglycerin, potentially causing a life-threatening drop in blood pressure.
NAFDAC said adult men with conditions such as diabetes, high blood pressure, high cholesterol and heart disease who use nitrate medications are particularly vulnerable to such complications.
The agency has advised the public to immediately stop using or selling the product and return any remaining stock to the nearest NAFDAC office.
Consumers were also encouraged to report adverse reactions or compromised products through the agency’s reporting platforms, including the Med-Safety mobile application and its official email channels.
NAFDAC reiterated its commitment to protecting public health through continued monitoring and surveillance of medicines, medical devices and other regulated products circulating in Nigeria.
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