FDA Orders Immediate Recall Of Arcan Bitters
The Food and Drugs Authority (FDA) has ordered Unni Associates Company Limited to recall its Arcan Bitters (35% Alc/Vol) product from the market within 14 days.
In a public release dated September 02, 2026, the Authority announced that the factory at Parkoso in the Asokore Mampong Municipality of the Ashanti Region that manufactures the product has been closed down.
According to the FDA, laboratory analysis conducted on Arcan Bitters established that the product has been adulterated with Sildenafil Citrate, a Phosphodiesterase Type 5 (PDE5) inhibitor, which is an undeclared drug substance.
Sildenafil Citrate is a prescription-only medicine used to treat erectile dysfunction in men as well as pulmonary arterial hypertension.
The Authority said the adulteration of food products is an offence under Section 100 (3) of the Public Health Act, 2012 (Act 851), which prohibits the manufacture, advertising or offer for sale of any adulterated product, or a product that is different from the nature, substance and quality of the prescribed standard.
Similarly, the FDA noted that it is an offence to manufacture, label, package, sell or advertise a food product in a manner that is false, misleading or deceptive as regards its character, nature, value, additives, quality, substance and composition.
“Arcan Bitters appears to have flouted all these requirements and more. Arcan Bitters is registered with the Authority as a Food Product (an alcoholic drink) and must not contain any drug substance,” the statement said.
The FDA warned that the presence of Sildenafil Citrate in a food product poses serious health and safety risks to the public. The substance can interact with other medicines to cause a sudden drop in blood pressure, which may lead to stroke and heart attack, as well as long-term health problems including loss of vision and hearing.
The public was therefore strongly advised to refrain from purchasing and consuming the product.
The FDA said it will conduct safe disposal of the recalled products and has warned the company that it risks further regulatory sanctions, including criminal prosecution, if it fails to abide by the directives.
It further urged the public, retailers and distributors to comply with the directive and report persons offering Arcan Bitters for sale to the nearest FDA offices to ensure complete removal of the product from trade.
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