The Food and Drugs Authority (FDA) has ordered Unni Associates Company Limited to recall its Arcan Bitters product from the Ghanaian market within 14 days, after laboratory analysis established that the alcoholic beverage had been adulterated with Sildenafil Citrate, a prescription-only medication used to treat erectile dysfunction.
Alongside the recall order, the FDA has shut down the company’s manufacturing facility located at Parkoso in the Asokore Mampong Municipality of the Ashanti Region, where the affected product was produced. The Authority said it would personally oversee the safe disposal of all recalled units once collected, while warning the company that failure to comply with the directives could result in further regulatory sanctions, including criminal prosecution.
According to the FDA, the regulatory action follows laboratory analysis conducted on Arcan Bitters, an alcoholic drink with a 35 percent alcohol by volume content, manufactured by Unni Associates Company Limited.
The analysis confirmed that the product had been adulterated with Sildenafil Citrate, a Phosphodiesterase Type 5 (PDE5) inhibitor that was not declared among the product’s listed ingredients.
The Authority explained that Sildenafil Citrate is a prescription-only medicine used clinically to treat erectile dysfunction in men, as well as pulmonary arterial hypertension, making its undeclared presence in a registered food product a serious regulatory and public health concern.
Product Registered as Food, Not Permitted to Contain Drugs
The FDA emphasised that Arcan Bitters is officially registered with the Authority as a food product, specifically classified as an alcoholic drink, and is therefore not permitted to contain any drug substance under its approved registration.
It described the presence of Sildenafil Citrate within the product as a clear violation of this classification, noting that Arcan Bitters “appears to have flouted all these requirements and more.”
Citing the specific legal grounds for its intervention, the FDA noted that the adulteration of food products constitutes an offence under Section 100(3) of the Public Health Act, 2012 (Act 851), which prohibits the manufacture, advertising or sale of any adulterated product, or one that differs from the nature, substance and quality prescribed by its registered standard.
The Authority further pointed out that it is similarly an offence under the same law to manufacture, label, package, sell or advertise a food product in a manner that is false, misleading or deceptive regarding its character, nature, value, additives, quality, substance or composition, all requirements the FDA said the product had failed to meet.
Serious Health Risks Linked to the Adulterant
The FDA was direct in outlining the specific health dangers posed by the presence of Sildenafil Citrate in a food product.
According to the Authority, the substance can interact with other medications to cause a sudden drop in blood pressure, a reaction that could potentially lead to stroke or heart attack in affected individuals.
“The presence of Sildenafil Citrate in a food product poses serious health and safety risks to the public, particularly through dangerous interactions with other medications.”
FDA
Beyond these acute risks, the FDA warned that prolonged or unintended exposure to Sildenafil Citrate could also result in long-term health complications, including loss of vision and hearing, further reinforcing the seriousness of the contamination identified in the product.
In light of these risks, the Authority strongly advised members of the public to refrain from purchasing or consuming Arcan Bitters until the recall process is fully completed and the product is confirmed to have been removed from circulation.
“We strongly advise the public to refrain from purchasing and consuming this product given the serious risks associated with its use,”
FDA
Call For Compliance and Public Reporting
The FDA further called on retailers and distributors currently stocking Arcan Bitters to comply fully with the recall directive and encouraged members of the public to report any individuals found offering the product for sale to the nearest FDA office.
The Authority said this level of public cooperation would be essential in ensuring the complete removal of the adulterated product from trade across the country.
The action against Arcan Bitters adds to the FDA’s continuing enforcement efforts against unsafe and adulterated products circulating within Ghana’s consumer markets. With the implicated factory now closed and the 14-day recall window in effect, attention will likely turn to how effectively the product is withdrawn from shelves nationwide, and whether further regulatory or criminal action follows against Unni Associates Company Limited as investigations continue.
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