FDA Orders Immediate Recall of Arcan Bitters Over Illegal Erectile Dysfunction Drug Adulteration

Ghana’s Food and Drugs Authority (FDA) has ordered an immediate market recall of Arcan Bitters, a popular alcoholic beverage, after laboratory tests confirmed the product was adulterated with Sildenafil Citrate. The manufacturer, Unni Associates Company Limited, has been given a 14-day ultimatum to remove all batches of the product from the trade. In addition to the mandatory recall, the FDA has summarily shut down the company’s manufacturing facility located in the Ashanti Region to prevent further production and distribution of the contaminated beverage.

Sildenafil Citrate is a potent pharmaceutical ingredient primarily prescribed for the treatment of erectile dysfunction. Its presence in Arcan Bitters—a drink containing 35% alcohol by volume—poses severe health risks to unsuspecting consumers. The FDA emphasized that because the product is registered as an alcoholic beverage, the inclusion of any medicinal drug substance is strictly prohibited. Under the Public Health Act, such adulteration is illegal and represents a significant breach of safety standards for food and drink products intended for public consumption.

Medical experts and the FDA warn that consuming Sildenafil Citrate without medical supervision, especially when combined with alcohol, can lead to life-threatening complications. Potential adverse effects include severe drops in blood pressure, heart attacks, strokes, and other long-term health issues. The authority cautioned that individuals with underlying cardiovascular conditions are particularly vulnerable when consuming undeclared prescription drugs, as these substances can interact dangerously with other medications or existing health conditions.

The FDA has instructed all retailers, wholesalers, and distributors to stop the sale of Arcan Bitters immediately and return existing stock to the manufacturer. Members of the general public are strongly advised to avoid purchasing or consuming the product and are encouraged to report any vendors still offering it for sale. The authority further stated that failure by Unni Associates Company Limited to comply with the recall directive within the specified 14-day timeframe may lead to additional legal sanctions and rigorous regulatory penalties to ensure public safety.