Two people have died and 106 have been hospitalized after ingesting Kobayashi Pharmaceutical Co.’s supplements containing benikoji, prompting domestic and overseas recalls from companies that use the malted rice ingredient.

The health ministry disclosed the deaths and hospitalizations on March 26 that were based on interviews the ministry conducted that day, as it ordered the company to destroy products containing benikoji. 

Almost 12 hours later on March 27, the company confirmed the two deaths. 

Kobayashi Pharmaceutical said it was notified by the bereaved family on March 26. The company did not disclose the time of death, gender or cause of death, and said it is "in the process of confirming the facts and a causal relationship."

Kobayashi Pharmaceutical has received approximately 3,000 inquiries. A ministry official said the number of cases of affected consumers is expected to increase.

Although the substance in question has not yet been identified, the ministry has determined that the products are considered to “contain a harmful substance that caused a health hazard” under the Food Sanitation Law.

In violation of Article 6 of the sanitation law, the ministry notified the Osaka city government, where Kobayashi Pharmaceutical is based, to issue an order to destroy three products containing benikoji.

The destruction order was issued for "Benikoji coleste-help," "Naishi-help plus cholesterol" and "Natto-kinase sarasara-tsubu gold," all of which are dietary supplements made with benikoji as an ingredient.

The Osaka city government on March 27 announced the issuance of the order to Kobayashi Pharmaceutical.

The company received the first report of health problems in mid-January and was investigating the cause, but delayed in notifying the government. The ministry received a report on March 22 for the first time.

The ministry subsequently asked the company to provide more detailed information, but officials said information was not readily available.

On March 26, the ministry summoned Kobayashi Pharmaceutical officials to the ministry’s office for questioning. 

The company reported that one person who had ingested the product had died of kidney disease.

Kobayashi Pharmaceutical said it also learned of the death of another person on the same day.

The ministry did not disclose detailed information on the two deceased individuals, but it said a doctor reported that the second deceased person had kidney damage.

In addition, the ministry said there were 106 people who required inpatient treatment at the time of the ministry’s interview, and the company’s inquiry desk had received approximately 3,000 consultations. 

The ministry will hold a meeting of experts this week and continue to request updates from the company on the status of the investigation.

RECALLS OF PRODUCTS WITH BENIKOJI

The movement to voluntarily recall products made with benikoji ingredients is spreading rapidly.

Foods containing benikoji vary, such as rice crackers, sake, miso, dressings, breads and many other items.

Noevir Co., a manufacturer and seller of cosmetics and other products based in Kobe, announced on March 26 that it is voluntarily recalling its dietary supplement called “Noevir DHA and EPA.”

A total of 240,000 units has been sold since 2013. The company said it decided to recall all distributed and sold products as a precautionary measure.

Noevir received a report from a contract manufacturer on March 22 that benikoji produced by Kobayashi Pharmaceutical is used in the dietary supplement. 

In response, Noevir suspended mail-order sales of the product on the same night. A Noevir spokesperson said, “At first, we had no idea that our products would be affected.”

The recalls are spreading to traditional foods as well.

On March 25, Kyoto Yamaroku and Ichinoden, both Kyoto-based manufacturers of saikyo-zuke products, announced a voluntary recall of some of their products.

Honda Miso Honten, which has been in business in Kyoto for more than 190 years, also announced a recall of its miso and soy sauce products.

“We have received inquiries from customers," a Honda Miso Honten official said. "We have just started the recall, so we cannot say how long it will take.”

Mamefuku, a company in Nagoya that has been in business for more than 80 years and manufactures and sells bean confections, has removed some products from its online store, such as “Benikoji koume” and “Ebi shio almond,” which are subject to recall.

RECALL OF PRODUCT SOLD IN TAIWAN

The recall effort is spreading overseas as well.

DHC Corp., a Tokyo-based major cosmetics company, announced that it is voluntarily recalling “DHC noshuku (concentrated) benikoji,” a dietary supplement sold in Taiwan.

This is the first time that a voluntary recall of a product has been announced overseas due to a series of problems.

This supplement was manufactured in Japan and sold in Taiwan. There have been no reports of health problems to date, DHC said.

A supplement with the same name is also sold in Japan, but the formula is different from the one sold in Taiwan and does not use Kobayashi Pharmaceutical's benikoji, the company said.

(This article was compiled from reports written by Kazuya Goto, Tomoki Morishita and Tomohiko Kaneko.)