Kobayashi Pharmaceutical’s beni kōji issue has prompted growing repercussions in Taiwan, where health authorities have announced steps that will help consumers get refunds from the Japanese drugmaker.

Taiwan is the only place outside of Japan to have seen reports of people falling ill after consuming the company's beni kōji, which is made by fermenting rice with red yeast.

The Taiwan Food and Drug Administration (FDA) said Wednesday that Kobayashi Pharmaceutical’s subsidiary in Taiwan had started accepting online and phone inquiries and begun collecting products from consumers who purchased the drugmakers’ beni kōji supplements in or from Japan.

Those who bought other manufacturers’ products that use Kobayashi’s beni kōji as ingredients have been asked to reach out to the individual manufacturers for refunds, but a separate line at Kobayashi Pharmaceutical’s Taiwan subsidiary will also take inquiries for consumers who are not sure where to call.

The FDA added that the Consumer Protection Committee, an agency under Taiwan’s top executive body, the Executive Yuan, will provide assistance to such consumers, including in the case of any future class-action lawsuit.

Kobayashi Pharmaceutical has not directly sold its problematic beni kōji supplements in Taiwan, but other companies and importers have sold products that contain Kobayashi's beni kōji as ingredients.

A spokesperson for the drugmaker's head office in Japan told The Japan Times on Thursday that the company’s Taiwan subsidiary is not involved in the import or sales of beni kōji ingredients, but that it is handling the recall process for the firm's supplements and consumer consultations.

The spokesperson declined to comment on the scale of the recall and consultations, or any possible future arrangements among the FDA, the drugmaker and its Taiwan subsidiary.

As of Thursday, 40 cases of “adverse reactions” had been reported in Taiwan involving people who consumed products with the drugmaker’s beni kōji as an ingredient, including six people who had consumed Kobayashi Pharmaceutical’s supplements purchased in Japan. Common symptoms reported in Taiwan include decline in renal function, blood in urine and lower back pain.

The Taiwan FDA had recorded 248 cases as of Thursday of companies voluntarily recalling products containing fermented red rice ingredients from Kobayashi Pharmaceutical, including beni kōji supplements made by Japanese manufacturer DHC.

While there is no record of Kobayashi Pharmaceutical’s beni kōji supplements being imported into Taiwan, a total of 11,115 kilograms of the drugmaker’s fermented red rice, used as a raw material, were imported from Japan in 56 batches from Jan. 1, 2022, to March 22, 2024, according to the Taiwan FDA.

In Japan, five people who took Kobayashi Pharmaceutical’s beni kōji supplements have died, with 219 hospitalized as of Tuesday, according to Japan's health ministry. The government is still investigating whether there is a causal relationship between the products and the reported health issues.

SHS Biotech, one of the two Taiwanese importers of Kobayashi Pharmaceutical’s raw ingredients, was inspected by local health officials on March 25, Taiwan’s Central News Agency reported. The same day, the company announced a recall for all fermented red rice ingredients, and called for the suspension of sales of products that had already been manufactured.

An official of SHS Biotech declined a request for an interview, saying only that the Taiwan FDA and Kobayashi Pharmaceutical were in the process of addressing the issue.

HealthTake, the other importer, also declined to comment.

One manufacturer of fermented red rice products in Taiwan, DaYi Bio, said on its website that it will accept returns for related orders sold after Jan. 1, 2023, even though it did not use ingredients from the problematic batch numbers announced by Kobayashi Pharmaceutical.

The Taipei Economic and Cultural Representative Office in Japan, Taiwan's de facto embassy in the nation, said in a statement on April 1 that it is “closely monitoring the progress and relief situation of relevant events in Japan,” and that it can assist in facilitating communication if domestic importers wish to communicate with their Japanese counterparts.