NAFDAC warns against unregistered Menofix capsules over safety concerns, possible liver risks

The National Agency for Food and Drug Administration and Control (NAFDAC) has warned healthcare professionals, medicine retailers and the public against the marketing, sale and use of Menofix Capsules, stating that the product is not registered with the agency and has not been evaluated for safety, quality or efficacy.

The warning was issued in Public Alert No. 035/2026, released on 18 July 2026, after NAFDAC received a complaint about the product's sale in Nigeria and concerns over possible liver-related adverse effects linked to some of its reported ingredients.

According to the agency, an investigation by its Post Marketing Surveillance Directorate confirmed that the product being marketed as Menofix by PureEve is not registered with NAFDAC.

Product differs from registered Menofix herbal products

NAFDAC clarified that the unregistered product should not be confused with two legitimately registered herbal products that carry similar names.

The agency said Menofix Herbal Capsule (NAFDAC Reg. No. A7-103321L) and Menofix Powder (NAFDAC Reg. No. A7-103342L) are registered under the Herbal and Nutraceuticals category and are manufactured by Gudugudu Herbal Worldwide Enterprises.

By contrast, the investigated product marketed by PureEve is promoted as a hormone-free, vegetarian-friendly multivitamin and herbal supplement intended to support women experiencing perimenopause and menopause.

NAFDAC raises safety concerns

NAFDAC said that because the product is unregistered, it has not undergone regulatory assessment to determine its safety, quality or effectiveness, and the agency has therefore not verified any claims made about it.

The regulator also noted that some ingredients reportedly contained in the marketed product have been associated with rare liver-related adverse reactions, including hepatitis, elevated liver enzymes, jaundice and, in very rare cases, liver failure.

Although the agency did not attribute these adverse effects directly to the product, it said the reported ingredient profile raises sufficient concern to warrant regulatory action.

Surveillance underway

NAFDAC said it has directed all zonal directors and state coordinators to intensify surveillance and remove the unregistered product wherever it is found.

The agency added that investigations are continuing to identify the product's distribution channels.

What pharmacists and medicine retailers should know

The alert reinforces the importance of verifying the regulatory status of medicines, herbal products and dietary supplements before stocking or dispensing them.

Pharmacists and other healthcare professionals should remain vigilant for products making therapeutic claims without evidence of NAFDAC registration and advise patients to obtain medicines and supplements only from authorised and licensed suppliers.

Consumers are also encouraged to check product packaging carefully and verify NAFDAC registration before purchase.

Reporting suspected products and adverse events

NAFDAC urged healthcare professionals, retailers and consumers to report suspected substandard, falsified or unregistered medical products to the nearest NAFDAC office or through the agency's reporting channels.

The regulator also encouraged the reporting of adverse drug reactions through its pharmacovigilance reporting platforms to support medicine safety monitoring across the country.

Why this matters

The alert highlights the continuing challenge posed by unregistered health products sold through physical and online retail channels. While dietary supplements and herbal products are widely used by women seeking relief from menopausal symptoms, NAFDAC's warning underscores that products lacking regulatory approval may expose consumers to unknown quality, safety and efficacy risks.