“This drug is not safe for pregnant women” – DFCA recalls Duphaston, Navidoxine

The Drug and Food Control Authority has ordered the immediate recall of Duphaston and Navidoxine from the South Sudanese market over concerns about their quality, possible falsification and patient safety.

Duphaston is a hormone medication used to treat several female reproductive health conditions, while Navidoxine is used to manage nausea and vomiting, including morning sickness in pregnant women.

In a letter issued on Wednesday, the DFCA said the recall follows information from Drug Eye Africa dated August 19, 2026, concerning the two medicines.

The authority said no batch of the recalled products is registered in South Sudan, meaning no specific batch could be exempted from the recall.

It says all batches found on the local market are therefore suspected of being falsified and must be withdrawn.

Speaking to Eye Radio on Wednesday, Dr. Peter Aguek Kon, Director-General for Inspection and Surveillance at the DFCA, said the authority received information about the medicines and was required to take action.

“We received information from the Drug Eye Africa about this drug and the need for us to take action. It is a substandard drug that has been recalled worldwide, not only in South Sudan,” Dr. Aguek said.

He attributed the alert to Drug Eye Africa, dated August 19, as the source of the recall information, while also referring to broader concerns raised over the medicines.

The regulator has directed pharmaceutical wholesalers, retail pharmacies and government health facilities, particularly gynecology departments, to immediately stop distributing the medicines and contact DFCA inspectors.

Dr. Aguek said the recall is necessary because patients could be exposed to serious risks if the products are falsified, substandard, or contain incorrect ingredients or quantities.

“This drug is not safe for people, especially pregnant women. It puts the woman at risk, and it also puts the child at risk,” he said.

The DFCA says some of the medicines currently circulating in South Sudan enter the country through informal cross-border trade, including what it described as “handbag business dealers” from Somalia, where concerns over the products had also been raised.

The authority stressed that only licensed pharmaceutical wholesalers are authorized to import or export medicines, and that retail pharmacies are not permitted to independently import or export pharmaceutical products.

Dr. Aguek warned pharmacies and other medicine retailers to comply with the recall, saying those found continuing to stock or distribute the medicines could face further action.

He urged pharmacies to bring the recalled products to the DFCA so the authority can collect and account for them.

“If you don’t collect the drugs from your pharmacy and we find them on your own, then another action may be taken. We cannot put them into our system or determine the quantity you have. Come to our office and bring them here,” Dr. Aguek said.

The DFCA has reiterated its call for all pharmaceutical wholesalers and retail pharmacies to immediately comply with the recall and surrender the affected medicines to the regulator.

The authority says it has a mandate to recall or suspend any medicine considered a threat to public health or patient safety.

When contacted for comment, the Pharmaceutical Society of South Sudan welcomed the recall.
Dr. Martin Makuek Chiman, the Secretary General, said the action was necessary to protect patients and the public from potentially unsafe medicines.

“As the Pharmacy Society, we welcome this move by the Drug and Food Control Authority, and we are very grateful that these two drugs have been identified as unsafe for patients and the public in general. It is a good move. We actually welcome it, and this is the way to go. What I know is that these two drugs pose a serious concern for patient safety because of their quality,” he said.