The health ministry inspected another factory in western Japan on Sunday as it seeks to find the cause of five deaths and numerous hospitalizations thought to be linked to Kobayashi Pharmaceutical Co. red yeast rice dietary supplements.

The factory in Wakayama Prefecture, run by a subsidiary of Kobayashi Pharmaceutical, took over the production of ingredients for the supplements following the closure of an aging plant in Osaka in December. The Osaka factory was searched on Saturday.

Kobayashi Pharmaceutical said Friday it detected puberulic acid, a natural compound made from blue mold, in ingredients, and that the substance may be the cause of the illnesses.

Officials of the health ministry head to a factory, run by a subsidiary of Kobayashi Pharmaceutical, for an inspection in Wakayama Prefecture, western Japan, on March 31, 2024. (Kyodo)

In addition to the five deaths, more than 110 people have been hospitalized with issues thought to be linked to their consumption of the supplements containing "beni-koji" red yeast rice.

Many of those affected developed kidney disease after consuming the supplements. Puberulic acid can be toxic, but its impact on the kidneys is unknown, according to the health ministry.

Microbiologists have speculated hygiene issues in the manufacturing process may have led to blue mold contamination in red mold that is used in the beni-koji products, saying there is no way for blue mold to occur in red mold otherwise.

Puberulic acid was found in the ingredients manufactured at the Osaka factory between April and October last year.

According to the Wakayama prefectural government, which also took part in Sunday's inspection, the factory in Kinokawa inherited equipment from Kobayashi Pharmaceutical's plant in Osaka and started production in January.

Of the three products that have been voluntarily recalled by Kobayashi Pharmaceutical, health complaints have largely come from those who consumed the "beni-koji choleste help" manufactured after September, according to the company. The pills have been marketed as a way to lower levels of LDL cholesterol, considered the "bad" cholesterol.

The Osaka-based company rolled out choleste help in February 2021, selling around 1 million units by the end of February this year. It is expected to take months to finish recalling the products.


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