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.

 

The FDA has consequently cautioned the general public, pharmacies and over-the-counter medicine sellers against the sale or use of any product originating from Omama Herbal Group Limited, describing such products as unauthorised and potentially life-threatening. It stressed that all marketing and distribution must cease immediately to prevent further risk to consumers.

 

The Authority also urged the public to remain vigilant, noting that some quantities of the product may still be in circulation. Consumers in possession of the mixture have been advised to discontinue its use and submit any remaining stock to the nearest FDA office.

 

Members of the public with information on the sale or distribution of the product are encouraged to report to the FDA through its official hotlines or regional offices. The Authority reaffirmed its commitment to ensuring that only safe, efficacious and quality products are available on the Ghanaian market.

 

Evidence of Falsification (Seized Pharmaceuticals): Visual evidence of the regulatory violations and support the public alert.

Figure 1: Large quantities of orthodox pharmaceutical products seized from the production facility. This visually confirms that the “herbal” product was being manufactured using conventional drugs like Multivitamin, Ferrous Sulphate, and Piroxicam capsules rather than herbal raw materials.

FIGURE 1
  • Adulteration Process (Dissolved Capsules)

Figure 2 and Figure 3: Show pharmaceutical capsules and tablets dissolved in open plastic buckets of water. These images clearly illustrate the unsafe and unauthorized method used to add allopathic medicines into the mixture.

FIGURE 2
FIGURE 3
  • Bulk Unsafe Production Scale of the operation

Figure 4: Featuring multiple large drums and buckets containing the finished brown liquid mixture ready for packaging. This supports the FDA’s findings that the product was confirmed to be the suspected Omama Herbal Mixture produced under non-compliant conditions.

FIGURE 4