At least 26 people have been hospitalized after taking dietary supplements produced by Kobayashi Pharmaceutical, which are being recalled due to reports of kidney and other health problems, the Osaka-based drugmaker said Monday.
The company said last week that 13 people developed health problems after taking supplements from a line of products containing beni kōji red yeast rice, with six of them being hospitalized and seven receiving outpatient treatment. One of them received dialysis.
The pharmaceutical company confirmed 20 additional hospitalizations by Sunday through a telephone consultation service line established over the issue.
It is voluntarily recalling five products, including about 300,000 packages of Beni Koji Choleste Help. As of February, the company had sold some 1.06 million packages of after it hit store shelves in February 2021.
The company suspects an unknown ingredient derived from molds may have caused the problems. Among notable reported symptoms were swelling and fatigue, alongside decreased kidney function.
Besides the products concerned, the company has also provided beni kōji as a food ingredient to 52 companies in Japan and abroad, including food- and beverage-makers as well as wholesalers.
In 2023, 16.1 tons of beni kōji were sold, of which 6.9 tons were used in supplements and other items. Kobayashi Pharmaceutical suspects a part of that 6.9 tons may have contained the harmful ingredient in question.
The company is calling on firms to remove any products that have beni kōji in their ingredients list from the market.
The company launched an investigation after a doctor notified it of health problems linked to the products in January.
Citrinin, a toxic metabolite produced by red yeast rice, has not been detected in the products, according to the company.
The beni kōji products are billed as helping lower levels of LDL cholesterol, known as "bad" cholesterol.