THE National Agency for Food and Drugs Administration and Control (NAFDAC), today, announced a voluntary recall of all lots of the male enhancement dietary supplement MR.7 SUPER 700000 capsules, citing serious safety concerns.
In a notice via its X handle, the agency said the recall follows an analysis by the US Food and Drug Administration (FDA), which found the product contains undeclared active ingredients—sildenafil and tadalafil.
“Sildenafil and tadalafil are phosphodiesterase (PDE-5) inhibitors found in FDA-approved products for the treatment of male erectile dysfunction.
“The presence of sildenafil and tadalafil in “MR.7 SUPER 700000’’ capsules render them unapproved drugs for which safety and efficacy have not been established and, therefore, subject to recall.
“MR.7 SUPER 700000 capsules are marketed online as a dietary supplement for male enhancement. Products containing sildenafil or tadalafil cannot be marketed as dietary supplements and could cause serious health risks,” NAFDAC warned.
“The presence of these undeclared ingredients renders the capsules unapproved drugs for which safety and efficacy have not been established, and therefore they are subject to recall,” it added.
The agency highlighted that consumption of such products may interact dangerously with nitrates found in prescription medications, including nitroglycerin, potentially causing a life-threatening drop in blood pressure.
It warned that adult males with diabetes, high blood pressure, high cholesterol, or heart disease who use nitrates are at greatest risk.
NAFDAC has advised the public to immediately stop using or selling MR.7 SUPER 700000 capsules and to return any remaining products to the nearest NAFDAC office.
The agency also encouraged consumers to report compromised products or adverse effects associated with any medicinal products or medical devices via its e-reporting platforms, Med-safety app, or through official email contacts: sf.alert@nafdac.gov.ng and pharmacovigilance@nafdac.gov.ng.
NAFDAC reaffirmed its commitment to safeguarding public health through continued surveillance of medicines, medical devices, and other regulated products circulating in Nigeria.
