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FDA orders recall of Franko Herbal Mixture over undeclared diazepam

Published: 2 hours ago
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The Food and Drugs Authority (FDA) has given Franko Herbal Centre 14 days to remove Franko Herbal Mixture from the market after laboratory tests found it contained diazepam and paracetamol, neither of which was listed among its ingredients.

The directive was issued in a product recall notice signed by the FDA’s Chief Executive Officer and dated October 19, 2026. The Authority asked members of the public, retailers and distributors to report anyone continuing to sell the product to the nearest FDA office.

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The FDA said the manufacturing facility operated by Franko Herbal Centre at Jacobu in the Ashanti Region had been closed. All products recovered under the recall will be safely disposed of, it added.

Franko Herbal Centre was warned that failing to follow the directive could lead to further regulatory action, including criminal prosecution.

The recall followed laboratory analysis of the mixture, which was manufactured by Franko Herbal Centre at Jacobu. It had been registered as containing three herbal plants: Carica papaya, Alstonia boonei and Tetrapleura tetraptera.

However, testing found that the product had been adulterated with diazepam and paracetamol. The FDA advised people not to buy or consume the mixture and urged retailers and distributors to comply with the recall.

The Authority also asked them to report any person offering the product for sale, saying this would assist efforts to remove it from the market.

The FDA described diazepam as a benzodiazepine and a prescription-only medicine used to treat anxiety disorders, acute alcohol withdrawal, muscle spasms and certain types of seizures.

Paracetamol, it said, is an over-the-counter medicine used to relieve mild-to-moderate pain and fever.

The Authority warned that including the two medicines in a herbal product created serious health risks. Diazepam can interact with other medicines and raise the risk of severe sedation, respiratory depression, coma and death.

The FDA said long-term use or abuse of diazepam could also affect the central nervous system, resulting in confusion, forgetfulness, dizziness, fatigue, nightmares, hallucinations, impaired judgement and seizures.

It further cautioned that taking too much paracetamol could cause severe liver damage and acute liver failure, which may be fatal without prompt treatment.

The adulteration of herbal medicinal products is an offence under Section 111 of the Public Health Act, 2012 (Act 851), the FDA said. The law prohibits the sale of adulterated herbal medicinal products.

It also prohibits the manufacture, labelling, packaging, sale or advertisement of herbal medicinal products in a manner that is false, misleading or deceptive about their character, nature, quality, substance or composition.

The Authority said Franko Herbal Mixture “flouts all these requirements and more”. Because it is registered as a herbal medicinal product, it must not contain any other drug substance.

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