The Food and Drugs Authority (FDA) has ordered a market recall of the Herbal medicine, Omama Herbal Mixture. This comes after the safety authority, in collaboration with the Ghana Police Service, conducted a market surveillance and laboratory tests on the medicine, after which they discovered it contained some harmful substances.

In a statement issued by the FDA on Friday, October 31, the regulatory body warned the public to desist from patronising the medicines.

The FDA mentioned that, while the herbal mixture has been registered as a medication for malaria and loss of appetite, it has been “ has been adulterated with Diazepam, Metronidazole, Paracetamol, and Niacinamide, which are allopathic medicines, warning that consumption of the mixture without a proper prescription has the potency to cause harm to the consumers.

“The Food and Drugs Authority (FDA), in collaboration with the Ghana Police Service, carried out market surveillance and laboratory analysis of Omama Herbal Mixture. The laboratory analysis revealed that Omama Herbal Mixture….It is important to note that Omama Herbal Mixture is registered as a herbal medicinal product indicated for malaria and loss of appetite, and is not expected to contain any allopathic medicines.

The medicines found in Omama Herbal Mixture are dangerous when taken without a prescription and/or advice from a qualified health professional. The public is, therefore, advised not to patronise Omama Herbal Mixture,” parts of the statement read.

Consequently, to ensure public safety, the FDA noted that it was working in collaboration with the Herbal Company to recall the products from the market.

“Meanwhile, the FDA is working with Omama Herbal Group Limited to recall all products on the market for safe disposal and appropriate regulatory actions, including criminal prosecution. The FDA wishes to assure the public that it will not relent in its efforts to ensure public health and safety”, the statement added.

The FDA also admonished the public to help promote consumer safety by reporting any person, pharmacy or entity that will be found selling the herbal mixture.

“The public is advised to provide information on persons, pharmacies, and over-the-counter medicine sellers (OTCMS) offering Omama Herbal Mixture for sale to the nearest FDA office”, the statement concluded.

In a related development, the FDA in early August suspended the manufacture of Tasty Tom Enriched Tomato Mix following consumer complaints and the FDA's investigation of Nutrifoods Ghana Limited's manufacturing plant, which established infractions on standards and quality.

In a statement issued August 3 by the Food and Drugs Authority, the national regulatory body noted that “maintenance of critical manufacturing equipment was poor, and monitoring systems were inadequate to protect public health and safety.”

The lapses at the manufacturing plant affected the integrity of the canned products by compromising the sealing mechanisms, leading to contamination and bloating of the products in pouches.

“Mould was found on some of them, raising serious health and safety concerns, hence the suspension and product recall,” the statement added.

A market recall of all canned Tasty Tom Enriched Tomato Mix products, and specific batches of the product in pouches (the 380g and 1.05kg pouches) was earlier directed by the FDA.

On August 1, NutriFoods Ghana Limited, following guidance from the FDA and National Security, after some incidents of bloating, recalled all batches of the Tasty Tom Enriched Tomato Mix in 210g and 400g Cans and Tasty Tom Enriched Tomato Mix in 380g and 1.05kg.

In a statement, Business Head of the company Jay Jagadip revealed that in January 2025, the FDA suspended the can manufacturing lines for the 210g and 400g Tasty Tom Enriched Tomato Mix and production had since ceased.

The company's manufacturing activities were suspended until further notice to ensure full compliance with all regulatory recommendations. The company entreated consumers to return any of its packages they suspected to be affected.

“Moreover, if you have any of the Tasty Tom Enriched Tomato Mix that you suspect may be affected, please return them to the above locations or contact the above number as well."

"We deeply regret any inconvenience caused to our consumers and trade partners because of this issue and recall. We at Nutrifoods Ghana Ltd are committed to delivering high-quality products meeting all the required stringent national food safety standards and ensuring our consumers are delighted with our products. We want to reassure our consumers and trade partners that we are doing our best to recover all affected products and replace them without difficulty,” the statement added.

The FDA has commenced internal investigations to ascertain if there were regulatory lapses, particularly because Nutrifoods had earlier in January 2025 been barred from manufacturing the product, in line with the Food and Drugs Authority’s commitment to transparency and accountability.

The FDA has noted that any dereliction of duty identified will be swiftly dealt with in order to strengthen the FDA's regulatory oversight. Meanwhile, the Food and Drug Authority has advised consumers, retailers and wholesalers to take note of this directive and act accordingly.

“We will continue to exercise rigorous oversight in accordance with our mandate to protect public health and safety,” the Authority assured.

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The Food and Drugs Authority (FDA)-Ghana was established in 1992 as the Food and Drugs Board (FDB) on the basis of the 1992 Food and Drug Law (PNDCL 305B), later amended by the Food and Drugs ACT of 1996. The Food and Drugs legislation was revised in 2012 and integrated into a new Public Health ACT 851, 2012, which gave birth to the Food and Drugs Authority.

The FDA’s legal mandate is found in Part 6 (Tobacco Control Measures), Part 7(organisation and responsibilities of the FDA), and Part 8 (Clinical trials) of the Public Health Act, 2012 Act 851.

It is the National Regulatory Body responsible for the regulation of food, drugs, food supplements, herbal and homoeopathic medicines, veterinary medicines, cosmetics, medical devices, household chemical substances, tobacco and tobacco products, blood and blood products as well as the conduct of clinical trial protocols.

The Governing Board, with the responsibility of ensuring the effective implementation of the functions of the Authority, has mission and vision statements which seek to protect the health and safety of people in Ghana and to be a global centre of excellence for food and medical product regulation.

The FDA executive committee, headed by the Chief Executive Officer (CEO) has responsibility for the daily operational management, service delivery and strategic issues of the organisation.

The committee, conscious of this mandate, has established a Quality Management System to ensure operational consistency, improved productivity, reduced costs, increased efficiency, better service delivery, and enhanced reputation, ultimately leading to customer satisfaction.

FDA’s quality management system (QMS) is a formalised system that has documented processes, procedures, and responsibilities for achieving quality policies and objectives.

It coordinates and directs the organisation’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continual basis.

This has led to the creation of a Quality Management Systems Department (QMSD) with a responsibility to establish, implement and maintain a quality management system in line with international standards like ISO 9001, ISO 17025, WHO-Prequalification and WHOGlobal Benchmarking Tool (WHO-GBT).

The FDA’s QMS is certified to ISO 9001:2015 for all its operations. Regulatory systems play a key role in assuring the quality, safety, and efficacy of medical products. Effective regulatory systems are an essential component of health systems and contribute to desired public health outcomes and innovation.