FDA orders recall of Franko Herbal Mixture over drug adulteration

The Food and Drugs Authority (FDA) has ordered Franko Herbal Centre to recall its Franko Herbal Mixture from the market within 14 days after laboratory analysis detected the presence of diazepam and paracetamol in the product.

The FDA has also shut down the company’s manufacturing factory at Jacobu in the Ashanti Region and warned that failure to comply with the directives could result in further regulatory sanctions, including criminal prosecution.

In a product recall notice dated October 19, 2026, with reference number FDA/CSD/CPE/PRL/26/009, the Authority said laboratory analysis established that the herbal mixture, registered to contain Carica papaya, Alstonei boonei and Tetrapleura tetraptera, had been adulterated with pharmaceutical substances.

Diazepam is a prescription-only medicine used to treat conditions including anxiety disorders, muscle spasms and certain types of seizures, while paracetamol is commonly used to relieve pain and reduce fever.

The FDA warned that the presence of these pharmaceutical substances in a product registered as an herbal medicine poses serious health and safety risks to consumers.

According to the Authority, diazepam can interact with other medicines and increase the risk of severe sedation, respiratory depression, coma and death. Long-term use or abuse may also cause confusion, forgetfulness, dizziness, fatigue, hallucinations, impaired judgment and seizures.

The FDA further cautioned that an overdose of paracetamol can cause severe liver damage and acute liver failure, which may be fatal if not treated promptly.

The Authority said the adulteration of herbal medicinal products constitutes an offence under Section 111 of the Public Health Act, 2012 (Act 851). It also stressed that herbal medicinal products must not contain undeclared pharmaceutical substances and must not be manufactured, labelled, packaged, sold or advertised in a false or misleading manner.

As part of the enforcement measures, the FDA will oversee the safe disposal of the recalled products to ensure their complete removal from circulation.

The Authority has strongly advised the public to stop purchasing and consuming Franko Herbal Mixture. Retailers and distributors have also been directed to comply with the recall and report anyone found selling the product to the nearest FDA office.

The FDA reiterated the importance of protecting public health and ensuring that medicinal products available on the Ghanaian market meet the required safety and regulatory standards.