NAFDAC Orders Recall Of Male Enhancement Capsules Over Safety Concerns

 

The National Agency for Food and Drug Administration and Control, NAFDAC, has warned the public about the recall of all batches of MR.7 Super 700000 capsules following safety concerns linked to undisclosed pharmaceutical ingredients.

The agency disclosed this on Monday in a public notice published on its website.

According to NAFDAC, the recall was initiated by the manufacturer, StuffbyNainax LLC, after the U.S. Food and Drug Administration (FDA) tested the product and

discovered it contains undeclared sildenafil and tadalafil.

These substances are commonly used in medications approved for treating Erectile Dysfunction.

NAFDAC explained that both ingredients belong to a group of medicines known as phosphodiesterase (PDE-5) inhibitors. Because the substances were not listed on the product label, the capsules are regarded as unapproved drugs whose safety and effectiveness have not been verified.

The product, which is promoted online as a dietary supplement for male enhancement, should not be sold as a supplement if it contains sildenafil or tadalafil, the agency stated.

The advisory identified the product as MR.7 Super 700000 capsules, manufactured by StuffbyNainax LLC and marketed as a male enhancement supplement. The recall applies to all batches currently available.

NAFDAC advised anyone in possession of the capsules to stop using or selling them and return them to the nearest NAFDAC office.

The agency also urged healthcare professionals and consumers to report suspected counterfeit or substandard medicines and any adverse reactions through its official reporting channels.

NAFDAC warned that consuming products containing undeclared sildenafil or tadalafil could pose serious health risks.

The agency explained that these substances can react with nitrates found in prescription medicines used to treat heart conditions, including Nitroglycerin. Such interactions may cause a sharp drop in blood pressure, which can be life-threatening.

People living with diabetes, high blood pressure, high cholesterol, or heart disease who often take nitrate-based drugs may be particularly vulnerable. Adult men using nitrates for cardiac conditions face the highest risk if they take the capsules.

The recall follows recent alerts by NAFDAC about the circulation of unsafe and falsified medicines in Nigeria.

The agency recently warned health workers and the public about counterfeit Avastin 400 mg vials circulating in the country.

The medicine, known as Avastin (Bevacizumab), is used to treat recurrent Glioblastoma in adults by blocking blood vessels that feed tumours.

According to NAFDAC, the suspected fake product was first reported by Roche after an oncologist at a local hospital questioned the authenticity of some Avastin vials labelled 400 mg/16 ml.

The agency reaffirmed its commitment to protecting public health through continued monitoring of the safety, quality and effectiveness of medicines and other regulated products in Nigeria.