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FDA Revokes Omama Herbal Mixture Licence After Dangerous Drug Adulteration Scandal
The Food and Drugs Authority (FDA) has revoked the marketing authorisation of Omama Herbal Mixture after a comprehensive laboratory analysis confirmed the product had been dangerously adulterated with multiple prescription-only medicines.
In a statement signed by the Acting Chief Executive Officer, Professor Kwabena Frimpong-Manso Opuni, the FDA said the decision followed a joint market surveillance operation conducted with the Ghana Police Service, which uncovered serious safety breaches.
According to the FDA, the tests revealed that Omama Herbal Mixture contained diazepam, metronidazole, paracetamol, and niacinamide—all allopathic drugs that are not approved for use in any registered herbal preparation.
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The Authority stated that Omama Herbal Mixture had been registered solely as an herbal remedy for malaria and loss of appetite, but the addition of these potent pharmaceutical substances posed grave health risks to unsuspecting consumers.
“The medicines found in Omama Herbal Mixture are dangerous when taken without prescription or advice from a qualified health professional,” the statement warned.
The FDA has therefore ordered an immediate halt to the sale and use of the product and is collaborating with Omama Herbal Group Limited to recall all affected batches from the market for safe disposal.
In addition, regulatory and criminal proceedings have been initiated against individuals and entities behind the adulteration. The FDA reaffirmed its commitment to protecting public health and maintaining the integrity of Ghana’s pharmaceutical and herbal markets.
“The FDA will not relent in its effort to ensure public health and safety,” the statement stressed.
The public has been urged to report any individuals, pharmacies, or over-the-counter medicine sellers found offering Omama Herbal Mixture for sale to the nearest FDA office or via official hotlines.
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