Theood and Drugs Authority (FDA) has ordered the immediate recall of Choice Irish Cream Flavoured Drink from the market after laboratory tests confirmed that it had been adulterated with Sildenafil Citrate, a prescription-only medicine used to treat erectile dysfunction and pulmonary arterial hypertension.
In a statement issued on Wednesday, the Authority said the drink, produced by 1 Africa Industries Limited, was registered as a food product and should therefore not contain any drug substance.
The presence of Sildenafil Citrate, a Phosphodiesterase Type 5 (PDE5) inhibitor, in the beverage, which was not declared on the product label, poses a serious public health risk, the FDA said.
It warned that consuming Sildenafil without medical supervision could lead to severe health complications, especially for individuals using medications such as nitroglycerin, as the combination can cause a sudden and dangerous drop in blood pressure, potentially resulting in heart attacks or strokes.
The Authority added that misuse of the substance could also cause painful or prolonged erections, psychological dependence, and long-term effects such as loss of vision or hearing.
“The public is therefore strongly advised to refrain from purchasing or consuming this product,” the FDA cautioned.
The FDA said it is working with 1 Africa Industries Limited to remove the product from the market for safe disposal and has initiated regulatory action against the company for adulterating a food product — an offence under Section 100 (4) of the Public Health Act, 2012 (Act 851).
Consumers, retailers, and distributors have been urged to comply with the recall directive and to report any continued sale of the product to the nearest FDA office.
