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Holle Food

FDA import alert and refusal historyRiehen, SwitzerlandFEI 3012639915

Recorded by FDA as HOLLE FOOD

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Example subjectHolle Foo added to Import Alert 16-129 (red list)

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As of October 26, 2026, Holle Food (Riehen, Switzerland) is on the red list of FDA Import Alert 40-05 (Adulterated and misbranded infant formula) for holle organic infant formula bio-folgemilch 2; holle organic infant powder formula bio 1, published by FDA on February 13, 2017, is also listed on Import Alert 99-39 (red list), and has 56 FDA import refusals recorded since October 2016.

Data from FDA public records, last checked . Request a correction

Current status

Import alerts
IA 40-05 · red listIA 99-39 · red list
Last import refusal
Other formula products, n.e.c., ready to feed · LIST INGRE
Last warning letter
None found
Last inspection
None on record

Every FDA record for Holle Food

58 records, newest first. Each line links to the FDA page it came from.

2026

  1. Import refusal
    Refused, Other formula products, n.e.c., ready to feedLIST INGRELACKS FIRMLACKS N/CEntry 1FX-5293249-8
    Source

2025

  1. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaINCONSPICUFALSEEntry 799-2982664-4
    Source
  2. Import refusal
    Refused, Other formula products, n.e.c., powder formulaFALSEHEALTH CEntry 799-1611981-3
    Source
  3. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry 799-2398492-8
    Source
  4. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFEntry 799-1736245-3
    Source
  5. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHNUTR DEFEntry 799-1429159-8
    Source
  6. Import refusal
    Refused, Other formula products, n.e.c., powder formulaNO ENGLISHEntry 799-1203490-9
    Source
  7. Import refusal
    Refused, Other formula products, n.e.c., powder formulaNO ENGLISHEntry 799-0662193-5
    Source
  8. Import refusal
    Refused, Milk base infant formula product (0-12 months), ready to feedFALSELACKS N/CNO ENGLISHEntry 799-0499887-1
    Source
  9. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHNUTR UNITEntry 799-0331361-9
    Source
  10. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaINCONSPICUFALSEEntry 799-0973266-3
    Source
  11. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-0483851-7
    Source
  12. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFFALSELACKS N/CNO ENGLISHEntry SCS-8902888-4
    Source
  13. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFLACKS FIRMLACKS N/CNUTRIT LBLEntry SCS-8857324-5
    Source

2024

  1. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry SCS-4791442-3
    Source
Show 43 earlier records (2016–2024)

2024

  1. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSENO ENGLISHEntry 799-0176433-3
    Source
  2. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSENO ENGLISHEntry 799-7773142-1
    Source
  3. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSELACKS N/CNO ENGLISHEntry 799-7692630-3
    Source

2023

  1. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry SCS-7943224-4
    Source
  2. Import refusal
    Refused, Other formula products for sample testing (not for sale), n.e.c.FALSEEntry SCS-7952002-2
    Source

2022

  1. Import refusal
    Refused, Baby and junior food n.e.c.LACKS N/CNUTRIT LBLEntry SCS-0059250-4
    Source

2019

  1. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-5663950-0
    Source
  2. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-4316572-6
    Source
  3. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-4285574-9
    Source
  4. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-5723755-1
    Source
  5. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-4316454-7
    Source
  6. Import refusal
    Refused, Powder infant formula products samples for testing (0-12 months)LACKS N/CNO ENGLISHNUTRIT LBLEntry SCS-6566047-5
    Source
  7. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-5668040-5
    Source
  8. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-5663809-8
    Source
  9. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-5337386-3
    Source
  10. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-4589922-3
    Source
  11. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-4282398-6
    Source
  12. Import refusal
    Refused, Milk base infant formula product (0-12 months), ready to feedSTD IDENTNO ENGLISHEntry AEK-5813355-1
    Source
  13. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLIST INGRELACKS FIRMLACKS N/CEntry SCS-5631638-4
    Source
  14. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry AEK-5611032-0
    Source
  15. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaSTD IDENTLACKS N/CNO ENGLISHNUTRIT LBLEntry AEK-5673832-8
    Source
  16. Import refusal
    Refused, Milk base infant formula product (0-12 months), ready to feedFALSEEntry AEK-5571856-0
    Source
  17. Import refusal
    Refused, Milk base infant formula product (0-12 months), ready to feedFALSEEntry AEK-5571810-7
    Source

2018

  1. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaINCONSPICUEntry AEK-4354482-1
    Source
  2. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-4326503-9
    Source
  3. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSENO ENGLISHEntry UPS-6180978-7
    Source

2017

  1. Import refusal
    Refused, 5 lines in one entry: Milk and cream, n.e.c., goat milk; Cereal grain soup, creamedLACKS N/CNUTRIT LBLEntry UPS-6339300-4Show 5 lines
    Source
  2. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry AEK-3919097-7
    Source
  3. Import refusal
    Refused, Milk base infant formula product (0-12 months), ready to feedINCONSPICUEntry AEK-3865507-9
    Source
  4. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-3855352-2
    Source
  5. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSENO ENGLISHEntry AEK-3783286-9
    Source
  6. Import refusal
    Refused, 2 lines in one entry: Milk base infant formula product (0-12 months), powder formulaFALSELACKS N/CNO ENGLISHEntry AEK-3522168-5Show 2 lines
    Source
  7. Import refusal
    Refused, Infant formula raw material component, n.e.c.,FALSEEntry AEK-3494307-3
    Source
  8. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-3167336-8
    Source
  9. Import alert listing
    Listed on Import Alert 99-39red listHolle Organic Infant Formula Bio-Folgemilch 2
    Source
  10. Import alert listing
    Listed on Import Alert 40-05red listHolle Organic Infant Formula Bio-Folgemilch 2; Holle Organic Infant Powder Formula Bio 1
    Source

2016

  1. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaSTD IDENTLACKS N/CNO ENGLISHNUTRIT LBLEntry 799-7603978-9
    Source
  2. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.NO ENGLISHNUTRIT LBLEntry 799-6849698-9
    Source

Refusal charges, in plain English

  • NO ENGLISH33 refused lines

    Required label information not in English

    Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

  • FALSE20 refused lines

    False or misleading labeling

    The labeling appeared to be false or misleading in some particular.

  • LACKS N/C19 refused lines

    Net quantity statement missing

    The packaged food appeared not to carry an accurate statement of the quantity of contents, such as net weight, measure, or count, on its label.

  • NUTRIT LBL11 refused lines

    Nutrition information missing from label

    The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

  • INCONSPICU4 refused lines

    Required information not conspicuous

    Information required on the label appeared not to be placed prominently or conspicuously enough to be read and understood by an ordinary consumer.

  • LACK NOTIF3 refused lines

    LACK NOTIF

  • LACKS FIRM3 refused lines

    Manufacturer name and address missing

    The packaged product's label appeared not to show the name and place of business of the manufacturer, packer, or distributor.

  • STD IDENT3 refused lines

    Does not conform to standard of identity

    The product appeared to be represented as a food that has an FDA standard of identity, but not to conform to that standard.

Questions about Holle Food

Is Holle Food on an FDA import alert?
Yes. As of October 26, 2026, Holle Food is on the red list of FDA Import Alert 40-05, “Adulterated and misbranded infant formula”, for holle organic infant formula bio-folgemilch 2; holle organic infant powder formula bio 1; FDA published the listing on February 13, 2017.
Has FDA refused shipments from Holle Food?
Yes. FDA refused 56 shipment lines from Holle Food between October 4, 2016 and August 3, 2026. The most recent, on August 3, 2026, was other formula products, n.e.c., ready to feed, charged as LIST INGRE (ingredients not listed).
Why did FDA refuse Holle Food's shipments?
The most frequent charges are NO ENGLISH (required label information not in english, 33 lines) and FALSE (false or misleading labeling, 20 lines).
What is Holle Food's FEI number?
Holle Food's FDA Establishment Identifier (FEI) is 3012639915.
Can shipments from Holle Food still enter the U.S.?
Shipments of holle organic infant formula bio-folgemilch 2; holle organic infant powder formula bio 1 from Holle Food can be detained without physical examination under Import Alert 40-05; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

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Get an email when FDA publishes anything new on Holle Food.

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Example subjectHolle Foo added to Import Alert 16-129 (red list)

Free for one supplier. No password, no card.

SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.