Red yeast rice supplements scandal: Kobayashi Pharmaceutical halts production, recalls all products amid kidney disease, death cases
Two death cases suspected to be linked to the product consumption were also reported.
Kobayashi Pharmaceutical has also requested its 52 business partners to stop the use of its red yeast rice raw materials in their products and to stop their sales of related products.
The Osaka-headquartered company is best known for its fever relief pad Koolfever, but its other businesses include the production and sale of health supplements, including those containing red yeast rice raw materials.
As of March 26, there were 50 additional hospitalised cases suspected to be linked with the use of its red yeast rice supplements, up from 26 cases reported from a day before.
The company was also informed of a death case where the consumer had passed away due to kidney disease and had been using its Red Yeast Rice Cholesterol Help before his passing. A notice from Japan's Consumer Affairs Agency said that two death cases have been reported.
In response to queries from NutraIngredients-Asia, Kobayashi Pharmaceutical said that production of its red yeast rice raw materials and all related products has been discontinued.
"The production has been discontinued and all products will be recalled. At the time of shipment, we conduct various tests such as the concentration of functional components and microbial tests," said the firm.
The company first announced a voluntary recall of its five SKUs containing red yeast rice due to consumer complaints of kidney disease last Friday (March 22).
The recalled products included a Food with Function Claims (FFC) known as Red Yeast Rice Cholesterol Help (紅麹コレステヘルプ) for 15-day, 20-day, and 30-day use. The products claim to lower the “bad” LDL-cholesterol.
The other two SKUs recalled include Naishi Help + Cholesterol (ナイシヘルプ＋コレステロール) for consumers with high body mass index (BMI) and LDL-cholesterol levels, and Nattokinase Smooth Grains (ナットウキナーゼさらさら粒GOLD).
A total of 14 batches sold in pharmacies and online and another four batches sold via mail order were affected by the recall, it added on Monday (March 25).
The company said it was conducting tests to identify the ingredients that were unexpectedly present in these products.
“We have confirmed [the presence of] ingredients that we did not have expected through ingredient analysis of products manufactured within the past year. We are currently conducting tests to identify these ingredients.”
Over 50 partners using Kobayashi’s red yeast rice raw material
On Monday (March 25), the company revealed that 52 other business partners have been using its red yeast rice raw materials and it would be contacting them to refrain from selling or using the raw material.
It further revealed that it had manufactured 18.5 tonnes of red yeast rice raw material last year, with about 13 per cent (2.4 tonnes) used in its products.
The remaining 16.1 tonnes were sold to partnering brands. Of which, 6.9 tonnes were supplied to companies for use as supplements and 9.2 tonnes for use as food colouring or flavouring.
Most of the raw materials were supplied within Japan, with some supplied to Taiwan.
Alcoholic beverages maker Takara Shuzo is one of the partnering brands that has recalled its products Mio Premium Rose sparkling sake 750ml and 300ml as they contained Kobayashi Pharmaceutical’s red yeast rice raw material.
Other products affected by the recall were a DHA & EPA supplement sold the under the brand Noevir, Morikawa Kenkodo's propolis chewables for kids, based on information from the CAA.
Taiwan FDA halts sales and use
The issue has caught the attention of Taiwan Food and Drug Administration, which announced on Monday a halt on the use and sales of Kobayashi Pharmaceutical’s red yeast rice raw material and related products.
It said that there were no registered records on the five Kobayashi Pharmaceutical’s products recalled in Japan. However, there were records of two local firms importing Kobayashi Pharmaceutical’s red yeast rice raw materials into Taiwan.
Records showed a total of 56 batches sent for inspection between January 2022 and March, 22 this year.
The Taiwan FDA has since contacted the two importers to recall the products and to stop the registration of red yeast rice raw materials and related products produced by Kobayashi Pharmaceuticals.
It has also warned companies that are using or selling red yeast rice extract produced by Kobayashi Pharmaceuticals to stop the sales and usage, and to voluntary recall these products.
Violators could face a penalty of NTD$30k to $3m (US$941- $94.2k).
The regulator added that it had inspected a total of 199 red yeast products between 2019 and 2023, including 12 dietary supplements in the form of tablets and capsules.
However, the inspection did not show the presence of the mycotoxin citrinin.
According to the US’s National Center for Complementary and Integrative Health, some red yeast rice products could contain citrinin – which is toxic and could damage the kidneys.
