FDA BANS OMAMA HERBAL MIXTURE OVER SAFETY CONCERNS

On October 31, 2025, the Food and Drugs Authority (FDA) took decisive action to safeguard public health by revoking the marketing authorisation for Omama Herbal Mixture, a product previously registered for the treatment of malaria and loss of appetite.

The action followed a joint operation between the Authority and the Ghana Police Service, which involved extensive market surveillance and detailed laboratory analysis. Findings from the investigation revealed that, contrary to its registration as a herbal medicinal product, the mixture had been adulterated with several allopathic medicines, including Diazepam, Metronidazole, Paracetamol and Niacinamide. The presence of these undeclared substances, the FDA noted, poses serious health risks, particularly when consumed without medical supervision.

Further investigations at the manufacturing facility of Omama Herbal Group Limited, located at Meduma in the Ashanti Region, uncovered what officials described as a complete disregard for pharmaceutical standards and public safety. Inspectors found that the so-called herbal product was being produced using dissolved orthodox pharmaceutical tablets and capsules, including Folic Acid and Diazepam, rather than plant-based raw materials. The site contained buckets of dissolved medications prepared for mixing, as well as a large quantity of unlabelled bottles, pointing to unsanitary production practices and deliberate mislabelling.

The Authority indicated that these findings confirm the product as falsified, having been manufactured under conditions that compromise both safety and quality, while misleading consumers as to its true composition.

In response, the FDA has initiated a nationwide recall of all Omama Herbal Mixture products and is working closely with the manufacturer to ensure their removal from the market and safe disposal. It further disclosed that criminal prosecutions have been instituted against the management of the facility.