Kobayashi Pharmaceutical’s beni-koji red yeast rice factory in Kinokawa City, Wakayama Prefecture, is under investigation by authorities following reports of deaths and hospitalizations associated with the product. Local media revealed that the production equipment at the Wakayama factory had been transferred from the Osaka facility, which had ceased operations due to outdated machinery. The company has expressed willingness to cooperate with authorities to determine the cause of the issues promptly.
In response to these health concerns, Kobayashi Pharmaceutical previously suggested that puberulic acid, a natural compound found in green mold during rice fermentation, could be linked to the adverse effects. However, the company acknowledged that the beni-koji production line did not meet Good Manufacturing Practices (GMP) standards.
On February 31, health officials from the Japanese Ministry of Health conducted an inspection at the factory in Wakayama Prefecture to investigate the presence of puberulic acid in the products and its potential toxicity. During a press conference on March 29, President and CEO Akihiro Kobayashi issued an apology for the problems faced by users and promised thorough investigations to identify the cause and implement necessary measures.
The company’s products are distributed in various countries in Asia, including China and Taiwan, where sales have been halted following the health concerns in Japan. As of March 27, Japan had reported five deaths and over 115 cases linked to the consumption of beni-koji products. The Food Safety Department of the Ministry of Health emphasized that these products were not authorized for sale in Vietnam and cautioned against purchasing them through unofficial channels. Any sightings of these products should be reported to authorities for appropriate action under Vietnamese law.
The investigation into Kobayashi Pharmaceutical’s manufacturing process will continue to assess its safety and its impact on public health.
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