The Food and Drugs Authority (FDA) has ordered the recall of Arcan Bitters from the Ghanaian market after laboratory analysis found the presence of undeclared Sildenafil Citrate, a prescription medicine used to treat erectile dysfunction and pulmonary arterial hypertension.
The FDA has directed Unni Associates Company Limited, the manufacturer of the alcoholic drink, to recall the product from trade within 14 days.
The factory at Parkoso in the Asokore Mampong Municipality of the Ashanti Region, where Arcan Bitters is manufactured, has also been shut down.
According to the FDA, laboratory tests established that the product, which is registered as a food product with an alcohol content of 35% Alc/Vol, had been adulterated with Sildenafil Citrate, a Phosphodiesterase Type 5 (PDE5) inhibitor.
In a statement dated September 2, 2026, the Authority said the presence of the undeclared drug substance in the alcoholic beverage poses serious health and safety risks to consumers.
“Sildenafil Citrate can interact with other medicines to cause sudden drop in blood pressure, which may lead to stroke and heart attack,” the statement warned.
The FDA also cautioned that the drug substance may cause long-term health complications, including loss of vision and hearing.
The Authority said the adulteration of food products is prohibited under Section 100 (3) of the Public Health Act, 2012 (Act 851), which bars the manufacture, advertising or sale of adulterated products.
It further noted that food products must not be manufactured, labelled, packaged, sold or advertised in a manner that is false, misleading or deceptive regarding their nature, quality, additives, composition or substance.
The FDA said Arcan Bitters appears to have violated these requirements, stressing that the product is registered as an alcoholic food product and therefore must not contain any drug substance.
The Authority will oversee the safe disposal of all recalled products and warned Unni Associates Company Limited that failure to comply with the directive could result in further regulatory sanctions, including criminal prosecution.
“The public is therefore strongly advised to refrain from purchasing and consuming this product. The Authority further advises the public, retailers and distributors to comply with this directive and report persons offering Arcan Bitters for sale to the nearest FDA offices to ensure complete removal of the product from trade,” the statement added.
Source:Fiilafmonline/CitiNews
