FDA orders recall of Franko Herbal Mixture over diazepam, paracetamol contamination

The Food and Drugs Authority (FDA) has ordered the recall of Franko Herbal Mixture from the Ghanaian market within 14 days after laboratory tests detected diazepam and paracetamol in the product, which is registered as a herbal medicinal preparation.

The Authority has also shut down the manufacturing factory of Franko Herbal Centre in the Ashanti Region and warned the company of further regulatory sanctions, including criminal prosecution, if it fails to comply with the recall directive.

In a product recall notice dated October 19, 2026, the FDA said laboratory analysis established that the mixture, manufactured by Franko Herbal Centre at Jacobu in the Ashanti Region, had been adulterated with pharmaceutical substances not declared as ingredients of the product.

The mixture was registered to contain herbal ingredients, including Carica papaya, Alstonia boonei and Tetrapleura tetraptera. However, the FDA said the presence of diazepam and paracetamol violated regulatory requirements governing herbal medicinal products, which must not contain other drug substances outside their approved composition.

The Authority warned that consuming the adulterated product could expose users to serious health complications because of the risks associated with the two pharmaceutical substances.

Diazepam is a prescription-only medicine belonging to the benzodiazepine class, used to treat conditions including anxiety disorders, acute alcohol withdrawal, muscle spasms and certain types of seizures.

According to the FDA, diazepam can interact with other medicines and increase the risk of severe sedation, respiratory depression, coma and death. Prolonged use or abuse may also affect the central nervous system, potentially causing confusion, forgetfulness, dizziness, fatigue, nightmares, hallucinations, impaired judgement and seizures.

Paracetamol, commonly used to relieve mild-to-moderate pain and reduce fever, can cause severe liver damage and acute liver failure when taken in excessive quantities.

The FDA said the presence of the substances in a product marketed as a herbal medicine posed a significant public health and safety concern and strongly advised the public against purchasing or consuming Franko Herbal Mixture.

The Authority said the adulteration of herbal medicinal products constitutes an offence under Section 111 of the Public Health Act, 2012 (Act 851), which prohibits the sale of adulterated herbal medicines.

The FDA said Franko Herbal Mixture breached these requirements, stressing that a product registered as a herbal medicine must not contain undeclared pharmaceutical substances.

It has directed retailers and distributors to comply strictly with the recall order and urged the public to report anyone offering the product for sale to the nearest FDA office to ensure its complete removal from the market.

The Authority warned that failure to comply with its directives could attract further regulatory sanctions, including criminal prosecution, as it moves to enforce the recall and protect public health.