FDA Mandates Recall of Franko Herbal Mixture, Cites Adulteration with Pharmaceutical Drugs
The Food and Drugs Authority (FDA) has issued a stringent directive for the immediate recall of Franko Herbal Mixture from the market within a 14-day period. This decisive action follows laboratory analyses that confirmed the presence of undeclared pharmaceutical substances, specifically diazepam and paracetamol, within the product. Concurrently, the FDA has ordered the shutdown of the Jacobu factory in the Ashanti Region responsible for its manufacture.
In a formal notice dated October 19, 2026, the regulatory body underscored the potential for further sanctions, including criminal prosecution, should Franko Herbal Centre fail to comply with the recall order. The FDA stated its intention to oversee the safe disposal of all recalled products. Laboratory findings revealed that the mixture, registered as a herbal medicine derived from *Carica papaya*, *Alstonei boonei*, and *Tetrapleura tetraptera*, had been adulterated with diazepam and paracetamol.
Diazepam, a prescription-only medication used for anxiety disorders, alcohol withdrawal, muscle spasms, and seizures, poses significant risks when combined with herbal formulations. The FDA highlighted that its presence in a herbal product can lead to severe sedation, respiratory depression, coma, and potentially death, particularly through interactions with other medications. Chronic use or abuse of diazepam can also impair central nervous system functions, manifesting as confusion, memory loss, dizziness, fatigue, nightmares, hallucinations, impaired judgment, and seizures.
Paracetamol, while a common over-the-counter analgesic and antipyretic, carries its own risks. An overdose can result in severe liver damage and acute liver failure, conditions that are life-threatening if not promptly treated. The FDA emphasised that the combination of these pharmaceutical drugs within a herbal product presents serious health and safety hazards to the public.
The FDA’s action is grounded in violations of the Public Health Act, 2012 (Act 851). Specifically, Section 111 of the Act prohibits the sale of adulterated herbal medicinal products. Furthermore, manufacturing, labelling, packaging, selling, or advertising a herbal product in a false, misleading, or deceptive manner, including misrepresenting its composition, constitutes an offence.
This regulatory intervention serves as a critical alert for legal professionals, compliance officers, and corporate executives. It underscores the imperative for rigorous due diligence in product formulation and labelling, particularly within the burgeoning herbal and traditional medicine sector. Investors and business leaders are reminded of the severe legal and reputational consequences of non-compliance with public health and safety regulations. The FDA strongly advises consumers against purchasing or consuming Franko Herbal Mixture and urges retailers and distributors to adhere strictly to the recall directive, reporting any continued sale of the product to the nearest FDA office.
