Recall of Red Yeast Rice food supplement due to an elevated level of monacolin K and missing warning statements

RASFF

Identification and classification

Reference

2025.4624

Notification ID

771630

Classification

information notification for attention

Risk decision

serious

Product type

food

Notification basis

official control on the market

Status

ec_validated

RASFF

Product

Description

Red Yeast Rice

Distribution status

Description

distribution restricted to notifying country

Notification ID

220

Notification ID

28999433

Category

Description

dietetic foods, food supplements and fortified foods

Notification ID

18439

Product descriptions

1. Notification ID

   28999469

   temperature

   Description

   ambient

   Notification ID

   27368

RASFF

Risk and analytical results

Notification ID

120317

RASFF

Hazards

1. analyticalResult

   7.0 ± 0.9

   Hazard category

   Description

   composition

   Notification ID

   28999512

   maxPermittedLvl

   3 mg

   maxPermittedLvlQuantities

   3

   maxPermittedLvlUnit

   mg

   Name

   monacolin K - too high intake - composition

   samplingDate

   15-04-2025 00:00:00

   unit

   mg

RASFF

Measures

1. Action taken

   Description

   recall from consumer

   Notification ID

   18836

   Notification ID

   28999832

   takenBy

   Notification ID

   5018

   isoCode

   IE

   organizationName

   Ireland

2. Action taken

   Description

   public warning - press release

   Notification ID

   18838

   Notification ID

   28999833

   takenBy

   Notification ID

   5018

   isoCode

   IE

   organizationName

   Ireland

   url

   https://www.fsai.ie/news-and-alerts/food-alerts/recall-of-ricepure-red-yeast-rice-food-supplement ↗

RASFF

Published territorial roles

1. Roles

   1. Role

      FOR_ATTENTION

      notificationId

      771666

   Organisation

   code

   INFO

   countryNetworkOrganizationId

   5680

   Description

   INFOSAN

   Notification ID

   10340

2. Roles

   1. Role

      NOTIFYING

      notificationId

      771630

   2. Role

      NOTIFYING

      notificationId

      771666

   3. Role

      FOR_ATTENTION

      notificationId

      771666

   4. Role

      NOTIFYING

      notificationId

      771630

   5. Role

      DISTRIBUTION

      notificationId

      771630

   6. Role

      NOTIFYING

      notificationId

      771630

   7. Role

      OPERATOR

      notificationId

      771630

   Organisation

   code

   IE

   countryNetworkOrganizationId

   5018

   Description

   Ireland

   Notification ID

   57

3. Roles

   1. Role

      FOR_ATTENTION

      notificationId

      774532

   2. Role

      ORIGIN

      notificationId

      771630

   3. Role

      OPERATOR

      notificationId

      771630

   Organisation

   code

   GB

   countryNetworkOrganizationId

   5014

   Description

   United Kingdom

   Notification ID

   17

RASFF

Follow-ups

1. fupDate

   20-06-2025 14:57:20

   fupId

   771666

   fupNumber

   1

   fupType

   Description

   notification reclassification

   Notification ID

   27670

   networkOrganizationId

   1

   organizationCode

   EU

   organizationDescription

   European Commission

2. fupDate

   03-07-2025 15:49:39

   fupId

   774532

   fupNumber

   2

   fupType

   Description

   follow-up from non-member country

   Notification ID

   27671

   networkOrganizationId

   1

   organizationCode

   EU

   organizationDescription

   European Commission

RASFF

Public links

5018

1. countryNetworkOrganizationId

   5018

   Notification ID

   23

   link

   http://www.fsai.ie/news_centre/food_alerts.html

2. countryNetworkOrganizationId

   5018

   Notification ID

   24

   link

   http://www.fsai.ie/news_centre/allergen_alerts.html