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 was registered as a herbal medicine.

The Authority has also shut down the manufacturing factory operated by Franko Herbal Centre at Jacobu in the Ashanti Region, warning that the company could face additional regulatory sanctions, including criminal prosecution, if it fails to comply with the directives.

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

The discovery raises concerns about the safety of consumers who may have purchased or used the product under the belief that it contained only the registered herbal ingredients.

According to the FDA, the presence of diazepam and paracetamol in a product registered as a herbal medicine violates the requirements governing its composition and raises significant public health concerns.

Diazepam is a benzodiazepine prescription medicine used to treat conditions including anxiety disorders, acute alcohol withdrawal, muscle spasms and certain types of seizures. However, the drug can cause drowsiness, dizziness, confusion, impaired coordination and memory problems.

The FDA also warned that diazepam can interact with other medicines, potentially increasing the risk of severe sedation, respiratory depression, coma and death. Prolonged use can also lead to dependence, while abrupt discontinuation after sustained use may cause dangerous withdrawal symptoms.

Paracetamol, on the other hand, is an analgesic and antipyretic medicine commonly used to relieve mild-to-moderate pain and reduce fever. Although it is widely available over the counter, excessive doses can cause severe liver damage and acute liver failure, which can be fatal without prompt medical treatment.

The FDA has therefore strongly advised the public to refrain from purchasing or consuming Franko Herbal Mixture.

The Authority has also directed retailers, distributors and members of the public to comply with the recall. Anyone who finds the product being offered for sale has been urged to report it to the nearest FDA office to facilitate its complete removal from the market.

As part of the enforcement measures, the FDA said it would supervise the safe disposal of the recalled products. Franko Herbal Centre has also been warned that failure to comply with the recall and factory-closure directives could result in further regulatory action, including criminal prosecution.

The Authority cited Section 111 of the Public Health Act, 2012 (Act 851), which prohibits the sale of adulterated herbal medicinal products. The law also prohibits the manufacture, labelling, packaging, sale or advertisement of herbal medicinal products in ways that are false, misleading or deceptive about their character, nature, quality, composition or other attributes.

The FDA stressed that a product registered as a herbal medicinal product must comply with the approved composition and must not contain undeclared pharmaceutical substances.

Consumers who have the product are advised not to take further doses and to seek guidance from a qualified healthcare professional if they have concerns about previous use, particularly if they experience unusual symptoms.

Anyone who has taken the mixture and develops severe drowsiness, confusion, difficulty breathing, or other serious symptoms should seek urgent medical attention.

The FDA's directive forms part of its responsibility to protect public health by ensuring that medicines and other regulated products on the Ghanaian market meet the required standards of safety, quality, and efficacy.

Consumers are encouraged to verify the registration status of herbal medicines and report suspected adulterated or improperly labelled products to the Authority.

EA