[4] On 22 March 2024, authorities reported that five people had died after consuming three products produced by Kobayashi Pharmaceutical, including "Red Koji Cholesterol Help".

[5] More than 240 people were hospitalized due to taking the supplement, and a total of 94,000 consultations were made, leading to a mandated recall as they were suspected of containing toxic and harmful substances.

[12] On 2 July, the city of Osaka requested the government of Mie Prefecture to investigate a case relating to the death to provide further information on the contamination and its spread.

[13] According to Dr. Ryuta Fujimura of the Department of Nephrology at the Higashiosaka Municipal Medical Center, who examined the hospitalized patients, the symptoms common to the victims were severe damage to the renal tubules which became crusted, chronic fatigue, loss of appetite, vomiting, and frequent urination, as well as an extreme deterioration in kidney test results, which were consistent with Fanconi syndrome.

[12] On 30 June 2024, The Japanese Society of Nephrology announced that approximately 85% of over 100 patients reported have not returned to normal kidney function over a month after ceasing the supplement.

[12] Due to prior research indicating the risk of causing kidney disfunction, in Switzerland, sales of red yeast rice are illegal, France, and the European Union have expressed safety concerns, Germany issued a warning not to consume it, and Taiwan recommends that people with chronic diseases seek professional medical advice before taking it.

[3] Additionally, earlier reports stated in April 2023 that there were hygiene issues with raw material production, which included picking up and reusing ingredients that had spilled on the floor.

It was also revealed that Kobayashi Pharmaceutical had a unique manufacturing method that included culturing it for more than three times the normal period to increase the concentration of its ingredients.

Professor Shinjiro Tachibana of the University of the Ryukyus pointed out that if the product is cultivated for a long time, it becomes difficult to control the temperature and moisture because additional work is required, such as adding water.

Professor Toshiro Watanabe of Sonoda Women's University pointed out that there is a risk of water entering through cracks in the tanks, a problem typical of aging factories.