At least 26 people have been hospitalized after taking dietary supplements produced by Kobayashi Pharmaceutical Co., 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-koji" 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," which by 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 swollenness and fatigue, alongside decreased kidney function.
Besides the products concerned, the company has also provided "beni-koji" as a food ingredient to 52 companies in Japan and abroad, including food and beverage makers as well as wholesalers.
Taiwan's public health authorities on Monday said two companies on the self-governed island have imported the same "beni-koji" ingredients used in the supplements concerned.
In 2023, 16.1 tons of "beni-koji" 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 western Japan company is calling on firms to remove any products that have "beni-koji" in their ingredients list from the market.
Taiwan's Ministry of Health and Welfare ordered the two firms to recall any products that contain the ingredients.
The Japanese pharmaceutical company launched its own investigation after a doctor notified it in January of cases involving patients having health problems linked to the products.
Citrinin, a toxic metabolite produced by red yeast rice, has not been detected in the products, according to the company.
The "beni-koji" products were expected to help lower levels of LDL cholesterol, known as "bad" cholesterol.
