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RASFFReference 2025.5836

undeclared active pharmaceutical ingredients sildenafil and tadalafil in honey-based food supplement from Thailand

Official information organised for easier consultation. The source publication remains authoritative.

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RASFF

Identification and classification

Reference
2025.5836
Notification ID
780728
Classification
information notification for attention
Risk decision
serious
Product type
food
Notification basis
official control on the market
Status
ec_validated

RASFF

Product

Description
Black Leopard Male Enhancement Honey
Distribution status
Description
product traded online
Notification ID
228
Notification ID
29441762
Category
Description
dietetic foods, food supplements and fortified foods
Notification ID
18439
Product descriptions
  1. Notification ID
    29441891
    productAspect
    10 sachets à 20 g
    temperature
    Description
    ambient
    Notification ID
    27368
    weight
    200.0
    weightUnit
    Description
    g
    Notification ID
    18974

RASFF

Risk and analytical results

hazardObserved
The sample contains the active pharmaceutical ingredients tadalafil at a concentration of 0.83 mg/g and sildenafil at a concentration of 9.57 mg/g. The typical dosage of medicines containing tadalafil is 10 or 20 mg of tadalafil once a day and for sildenafil 25, 50 or 100 mg once a day. The daily dose of this sample is one sachet per day according to the information on the label. One sachet contains 20 g, which corresponds to 16.6 mg of tadalafil and 191.4 mg of Sildenafil. Side effects and interactions are known for medicines containing one or the other substance. They should not be combined with certain medicines such as nitrates or molsidomine. Side effects such as low blood pressure, dizziness or vision problems may make you unfit to driving or operating machinery. Furthermore, sildenafil and tadalafil are not declared in this product. The consumer therefore cannot know what they are ingesting and cannot assess the risks accordingly.
Notification ID
122160

RASFF

Measures

  1. Action taken
    Description
    (requested) removal of online offer
    Notification ID
    18850
    Notification ID
    29442082
    takenBy
    Notification ID
    5023
    isoCode
    LU
    organizationName
    Luxembourg
  2. Action taken
    Description
    withdrawal from recipient(s)
    Notification ID
    18844
    Notification ID
    29442102
    takenBy
    Notification ID
    5023
    isoCode
    LU
    organizationName
    Luxembourg

RASFF

Origin, notification and distribution

Origin
Thailand
Notifying country or territory
Luxembourg
Published distribution
Luxembourg
Affected territories
Luxembourg

RASFF

Published territorial roles

  1. Roles
    1. Role
      FOR_FOLLOW_UP
      notificationId
      781939
    2. Role
      FOR_ATTENTION
      notificationId
      780728
    3. Role
      OPERATOR
      notificationId
      781939
    4. Role
      OPERATOR
      notificationId
      780728
    Organisation
    code
    FR
    countryNetworkOrganizationId
    5013
    Description
    France
    Notification ID
    14
  2. Roles
    1. Role
      FOR_ATTENTION
      notificationId
      780840
    Organisation
    code
    INFO
    countryNetworkOrganizationId
    5680
    Description
    INFOSAN
    Notification ID
    10340
  3. Roles
    1. Role
      NOTIFYING
      notificationId
      780728
    2. Role
      NOTIFYING
      notificationId
      780728
    3. Role
      DISTRIBUTION
      notificationId
      780728
    Organisation
    code
    LU
    countryNetworkOrganizationId
    5023
    Description
    Luxembourg
    Notification ID
    18
  4. Roles
    1. Role
      FOR_ATTENTION
      notificationId
      782488
    2. Role
      ORIGIN
      notificationId
      780728
    Organisation
    code
    TH
    countryNetworkOrganizationId
    5216
    Description
    Thailand
    Notification ID
    10211

RASFF

Follow-ups

  1. fupDate
    31-07-2025 15:33:14
    fupId
    780840
    fupNumber
    1
    fupType
    Description
    corrigendum
    Notification ID
    27663
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission
  2. fupDate
    06-08-2025 07:31:54
    fupId
    781939
    fupNumber
    2
    fupType
    Description
    additional information
    Notification ID
    27658
    networkOrganizationId
    3
    organizationCode
    DE
    organizationDescription
    Germany
  3. fupDate
    07-08-2025 16:14:33
    fupId
    782488
    fupNumber
    3
    fupType
    Description
    request
    Notification ID
    27665
    networkOrganizationId
    1
    organizationCode
    EU
    organizationDescription
    European Commission

RASFF

5013
  1. countryNetworkOrganizationId
    5013
    Notification ID
    14
  2. countryNetworkOrganizationId
    5013
    Notification ID
    15
    link
    http://www.economie.gouv.fr/dgccrf/Securite/Alertes/Avis-rappels-de-produits
5023
  1. countryNetworkOrganizationId
    5023
    Notification ID
    26
    link
    http://www.securite-alimentaire.public.lu/
  2. countryNetworkOrganizationId
    5023
    Notification ID
    27
    link
    lu-alert.lu

Provenance and context

NagameAlert organises public RASFF data while preserving official values and keeping notification classification separate from the risk decision. The official record remains authoritative and should be checked for follow-ups and current status.