The Food and Drugs Authority (FDA) has directed Franko Herbal Centre to recall its Franko Herbal Mixture from the market within 14 days after laboratory tests detected diazepam and paracetamol in the product. The Authority has also shut down the company’s manufacturing facility at Jacobu in the Ashanti Region, warning that failure to comply with the directives could result in additional regulatory sanctions, including criminal prosecution.
In a statement, the FDA said it would supervise the safe disposal of all recalled products to ensure they are completely removed from circulation and safeguard public health. The action follows laboratory analysis of Franko Herbal Mixture, which is registered with the Authority as a herbal medicinal product containing Carica papaya, Alstonei boonei and Tetrapleura tetraptera.
However, the tests revealed that the product had been adulterated with diazepam, a prescription-only medicine, and paracetamol, a drug commonly used to relieve pain and reduce fever. According to the FDA, the inclusion of these pharmaceutical substances in a product registered exclusively as a herbal medicine breaches regulatory requirements and presents significant health and safety risks to consumers.
The Authority explained that diazepam belongs to a class of medicines known as benzodiazepines and is prescribed to treat conditions such as anxiety disorders, acute alcohol withdrawal, muscle spasms and certain types of seizures. Although diazepam has legitimate medical applications, the FDA warned that its presence in an unapproved herbal formulation could expose consumers to dangerous side effects, particularly when taken alongside other medications.
It noted that diazepam can interact with other drugs, potentially increasing the risk of severe sedation, respiratory depression, coma and death. The FDA further cautioned that prolonged use or misuse of the drug could affect the central nervous system, leading to symptoms such as confusion, forgetfulness, dizziness, fatigue, nightmares, hallucinations, impaired judgement and seizures.
The Authority also expressed concern over the detection of paracetamol in the mixture. While the medicine is widely used for the short-term relief of mild to moderate pain and fever, excessive consumption can cause serious health complications.
The FDA has therefore urged consumers to avoid the Franko Herbal Mixture as the recall and other enforcement measures are carried out, stressing that the risks associated with the two substances make it necessary to remove the product from the market.
