Red Yeast Rice Contamination Causes Death, Nephrotoxicity
Summary
USP issued a caution notice on April 24, 2026 alerting stakeholders that *Penicillium adametzioides* contamination of red yeast rice dietary supplements has been linked to death and nephrotoxicity. The Dietary Supplement Admissions, Evaluation, and Labeling Expert Committee advised manufacturers to consider screening for this contaminant and related compounds such as puberulic acid. USP is not proposing changes to the Red Yeast Rice monograph at this time.
“USP is aware of an incident involving the contamination of certain Red Yeast Rice dietary supplements.”
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What changed
USP published a safety alert regarding Penicillium adametzioides contamination identified in red yeast rice dietary supplements, linked to fatalities and nephrotoxicity. The notice recommends that manufacturers consider implementing contaminant screening, including testing for puberulic acid, in their red yeast rice products. USP standards are incorporated by reference in FDA regulations, giving this notice indirect regulatory significance. Quality assurance teams at dietary supplement manufacturers should review this alert and assess whether existing supplier qualification and incoming material testing protocols adequately address fungal contamination risks for red yeast rice.
Archived snapshot
Apr 28, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Caution Notice for Red Yeast Rice
Type of Posting: General Announcement
Posting Date: 24-Apr-2026
USP is aware of an incident involving the contamination of certain Red Yeast Rice dietary supplements. After consultation with the Dietary Supplement Admissions, Evaluation, and Labeling Expert Committee (DSAEL EC), USP is notifying stakeholders that Penicillium adametzioides contamination of red yeast rice has resulted in death and other serious adverse reactions including nephrotoxicity. It is strongly advised that manufacturers consider the need to screen for contaminants, including puberulic acid, in red yeast rice.
USP and the DSAEL EC are not proposing changes to the Red Yeast Rice monograph at this time. This notice will be linked in the Red Yeast Rice monograph for stakeholders’ awareness.
If you have questions or comments, please contact Cuiying Ma, Senior Principal Scientist (cm@usp.org)
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