- Kobayashi Pharmaceutical is investigating a death and hospitalizations linked to its red yeast rice pills.
- At least 76 people admitted themselves to the hospital after consuming beni kōji fermented rice products.
- The company voluntarily recalled five products and urged customers to discontinue their use.
Kobayashi Pharmaceutical reported the illnesses after voluntarily recalling five products last week. The firm urged customers to discontinue the use of the pills, which were marketed as cholesterol-lowering supplements.
Kobayashi stated that it suspects the issue may have arisen from previously undetected toxic substances in molds utilized during production.
Beni kōji involves fermenting rice with monascus purpureus, a type of reddish-purple mold. Although they market it as a health supplement for high cholesterol and blood pressure, people also commonly use it as a traditional food colorant.
On Tuesday, the company released a statement declaring the "causal relationship" between its Red Yeast Cholesterol Help product and the customer's death.
The company stated that it had received a message from the bereaved family indicating that the individual had died from kidney disease and had been using the Red Yeast Cholesterol Help product for the past three years. The firm mentioned that there had been a regular mail order.
"Although we are diligently confirming the facts and causal relationships, we would like to report this from the perspective of prompt information disclosure," Kobayashi said. "Our company has always prioritized the health of our customers above all else and we sincerely apologize for this situation."
Customers experiencing symptoms such as changes in urine color, limb swelling, and fatigue had reported their concerns.
The company initiated an investigation after a doctor brought reported health issues to their attention in January. Subsequently, it established a hotline for customers.
According to Japanese media, the Red Yeast Cholesterol Help product was introduced to shelves in February 2021. The company has reportedly sold more than a million packets thus far.
The firm also distributed beni kōji as a food ingredient to food and beverage manufacturers worldwide. It issued a warning to companies about the risk last week.
As of now, no companies have reported any illnesses among customers. However, one major beverage maker, Takara Shuzo Co, declared that it would recall a sparkling sake product colored with the supplied beni kōji.
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