Two people are believed to have died and over 100 hospitalized after consuming red yeast rice dietary supplements from Kobayashi Pharmaceutical Co., the Japanese drugmaker and the health ministry said Tuesday, amid swelling safety concerns over the products.

One person was reported by the Osaka-based drugmaker to have died from kidney disease after apparently taking the "beni-koji" supplements for around three years. A second death was reported to the Ministry of Health, Labor and Welfare following a hearing with the company.

The number of people hospitalized after taking the supplements has jumped to 106, and the government has said it will conduct emergency checks on a type of food touting health benefits under the responsibility of producers, a category that includes some 6,000 products.


The fatal case reported earlier was the first known death with a possible link to supplements containing red yeast rice after Kobayashi Pharmaceutical last week voluntarily recalled five products, including about 300,000 packages of "beni-koji choleste help" that was labeled as helpful in lowering cholesterol.

The individual is said to have ordered a total of 35 "choleste help" packages on a regular basis from April 2021 to February 2024, the company said, adding that it is examining the causal relationship between ingestion and the person's death in February.

The company was notified of the death via an email from the family on Saturday, it said. But it was only on Monday that it noticed the message because it was flooded with a massive number of inquiries from the public.

The company met with bereaved family members in the first reported death on Tuesday as it seeks to confirm the individual's symptoms and other details regarding how the supplement was consumed.

According to Kobayashi Pharmaceutical, the problematic batch of beni-koji was manufactured at a factory in Osaka.

The second death was confirmed after the health ministry and the Consumer Affairs Agency conducted a hearing with officials from the pharmaceutical company to ascertain whether it has appropriately responded to the cases in line with the law.

Kobayashi Pharmaceutical has requested all companies supplied with its beni-koji to voluntarily recall products that use the same ingredient, with the incident affecting a wide range of products including sake, confectionery, bread and miso.

The nationwide voluntary recall has been extended to include food items and seasonings that feature beni-koji as an ingredient, as it is used for various purposes such as coloring and flavoring.

Photo taken March 26, 2024, shows Kobayashi Pharmaceutical Co.'s factory in Osaka. (Kyodo)

In China, online sales of products subject to the drugmaker's voluntary recalls have been suspended, local media said. Products have also been removed from circulation in Taiwan.

Chinese media have pointed to the possibility that the fermentation process of beni-koji may produce the toxic substance citrinin that could lead to kidney disease, but Kobayashi Pharmaceutical has said the ingredient produced by the company does not contain citrinin.

Related coverage:

26 hospitalized after taking Japan drugmaker's health supplements