Food and Drugs Authority (FDA) has issued a public alert over the circulation of falsified “Dr. Alfred Capsules,” a dietary supplement marketed for male vitality, warning that the counterfeit variants being sold on various social media platforms have not been registered by the Authority and have been found adulterated with an undeclared prescription drug substance.
According to the FDA, regulatory intelligence gathering and subsequent enforcement operations led to the identification of an organised syndicate operating between Accra and Suhum, responsible for manufacturing and distributing the falsified products across the country.
Two suspects linked to the illicit operation are currently on police enquiry bail, assisting investigators with ongoing inquiries into the scale and reach of the network.
The FDA disclosed that the falsified Dr. Alfred Capsules are being produced in unauthorised, unregulated and unhygienic environments, a factor the Authority said poses a critical public health risk to unsuspecting consumers who purchase the product without knowledge of its true origin or composition.
Laboratory Analysis Confirms Sildenafil Citrate Adulteration
Laboratory analysis conducted by the FDA’s Centre for Laboratory Services and Research (CLSR) confirmed that the falsified variants of Dr. Alfred Capsules had been adulterated with Sildenafil Citrate, a Phosphodiesterase Type 5 (PDE5) inhibitor that was not declared as an ingredient in the product.
The Authority explained that Sildenafil Citrate is a prescription-only medicine used to treat erectile dysfunction in men, as well as pulmonary arterial hypertension, making its undisclosed presence within a dietary supplement a serious regulatory and safety violation.
“The registered product does not contain Sildenafil citrate, and its undeclared presence in the falsified variant represents a direct and serious threat to consumer safety,”
FDA
The FDA clarified that the authentic, registered version of the product is manufactured by CV Al Manar Herbafit, located in Imogiri, Bantul, DI Yogyakarta, Indonesia, and is registered in Ghana by Unateus Ghana Limited as a food supplement.
Key Differences Between Authentic and Falsified Products
To help the public distinguish between the genuine and falsified products, the FDA outlined several distinguishing features across security sealing, capsule composition, packaging and batch information.
On security sealing, the Authority noted that the registered product features uniform, intact tamper-evident sealing unique to the Marketing Authorisation Holder on the bottle cap, complete with an aluminium inner seal visible upon first opening.
The falsified product, by contrast, is often missing safety seals on the bottle caps and may or may not include an aluminium inner seal.
Regarding capsule and content composition, the FDA explained that the registered product contains a standardised wine-red capsule shell with uniform off-white fine powder inside, while falsified variants display stark differences in capsule shell colours, including transparent or black-and-red shells, containing a greenish-brown powder inside.
On packaging and print quality, the Authority noted that the registered product features high-quality container material, distinctive text alignment and secure, premium exterior finishes, sold exclusively in a pack size of 30 capsules.
Falsified products, however, typically show low-quality container material, inferior print resolution, and blurred or altered typography, with varying pack sizes of either 30 or 60 capsules.
The FDA further explained that the registered product carries clear, traceable batch numbers matching on both the label and the base of the container, whereas falsified products often show no matching batch numbers between the label and container base, and frequently bear fictitious FDA registration numbers on their labels.
Advice To the Public and Retailers
In light of these findings, the FDA strongly advised members of the public to desist from purchasing medications, herbal remedies or dietary supplements from unverified online networks and social media handles, given the difficulty of authenticating such products outside regulated retail channels.
The Authority further directed all pharmacies, herbal shops and distributors to immediately inspect their existing stock and report any suspected falsified products to the FDA without delay.
Anyone found to be in possession of the falsified Dr. Alfred Capsules was urged to immediately return the product to the nearest FDA regional office nationwide.
The FDA confirmed that it continues to conduct active market surveillance and digital monitoring efforts aimed at ensuring that all remaining traces of the illicit falsified variants are fully removed from circulation across the country.
With two suspects already assisting investigations, further enforcement action is expected as the FDA works to dismantle the wider network believed to be behind the manufacture and distribution of the counterfeit product.
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