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Holle Baby Food GmbH

FDA import alert and refusal historyRiehen, SwitzerlandFEI 3011589751

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Example subjectHolle Baby Food Gmb added to Import Alert 16-129 (red list)

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As of October 26, 2026, Holle Baby Food GmbH (Riehen, Switzerland) is on the red list of FDA Import Alert 40-05 (Adulterated and misbranded infant formula) for holle organic infant follow-on formula 2; holle goat stage pre organic infant milk formula (holle bio pre anfangsmilch aus ziegenmilch), published by FDA on April 14, 2017, is also listed on Import Alert 99-39 (red list), and has 87 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
Milk base infant formula product (0-12 months), powder formula · LACK NOTIF
Last warning letter
None found
Last inspection
None on record

Every FDA record for Holle Baby Food GmbH

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

2026

  1. Import refusal
    Refused, 2 lines in one entry: Milk base infant formula product (0-12 months), powder formulaLACK NOTIFINCONSPICUFALSENO ENGLISHEntry 1FX-8169488-7Show 2 lines
    Source
  2. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFFALSENO ENGLISHEntry 1FX-6538142-8
    Source
  3. Import refusal
    Refused, 2 lines in one entry: Other formula products, n.e.c., powder formulaLIST INGREFALSELACKS FIRMLACKS N/CEntry 1FX-8249756-1Show 2 lines
    Source
  4. Import refusal
    Refused, Other formula products, n.e.c., powder formulaFALSEEntry 1FX-4412374-3
    Source
  5. Import refusal
    Refused, Milk base infant formula product (0-12 months), ready to feedFALSEEntry 1FX-4316605-7
    Source
  6. Import refusal
    Refused, Infant formula raw material component, n.e.c.,LABELINGEntry 1FX-6943709-2
    Source
  7. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLABELINGEntry 799-7914661-3
    Source
  8. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFINCONSPICUNO ENGLISHNUTRIT LBLEntry 1FX-2605559-9
    Source
  9. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSELACKS FIRMEntry 799-9187143-8
    Source
  10. Import refusal
    Refused, 2 lines in one entry: Other formula products, n.e.c., powder formulaNUTR DEFEntry 799-1625227-9Show 2 lines
    • Refused, Other formula products, n.e.c., powder formulaNUTR DEFEntry 799-1625227-9Source
    • Refused, Other formula products, n.e.c., powder formulaNUTR DEFEntry 799-1625227-9Source
    Source
  11. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLACK NOTIFINCONSPICUNO ENGLISHNUTRIT LBLEntry 799-5119683-7
    Source
  12. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLIST INGREINCONSPICUFALSELACKS FIRMLACKS N/CNO ENGLISHEntry 799-2033496-4
    Source
  13. Import refusal
    Refused, Infant formula raw material component, n.e.c.,FALSEEntry 799-6878642-9
    Source
  14. Import refusal
    Refused, Other formula products, n.e.c., powder formulaLACK NOTIFINCONSPICUFALSELACKS N/CNUTRIT LBLEntry 799-5008057-5
    Source
  15. Import refusal
    Refused, Infant formula raw material component, n.e.c.,LIST INGREFALSELACKS FIRMLACKS N/CEntry 1FX-0189359-2
    Source
Show 71 earlier records (2016–2026)

2026

  1. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry 799-2196068-4
    Source
  2. Import refusal
    Refused, Infant formula raw material component, n.e.c.,FALSEEntry 799-8716539-9
    Source
  3. Import refusal
    Refused, Other formula products, n.e.c., ready to feedFALSEEntry 799-9695062-5
    Source
  4. Import refusal
    Refused, 2 lines in one entry: Milk base infant formula product (0-12 months), powder formulaLIST INGRENUTRIT LBLEntry 799-4234167-1Show 2 lines
    Source
  5. Import refusal
    Refused, 3 lines in one entry: Other formula products, n.e.c., powder formula; Milk base infant formula product (0-12 months), powder formulaFALSEEntry 799-3337060-6Show 3 lines
    • Refused, Other formula products, n.e.c., powder formulaFALSEEntry 799-3337060-6Source
    • Refused, Other formula products, n.e.c., powder formulaFALSEEntry 799-3337060-6Source
    • Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry 799-3337060-6Source
    Source

2025

  1. Import refusal
    Refused, 2 lines in one entry: Other formula products, n.e.c., powder formulaNUTR DEFEntry 799-0375066-2Show 2 lines
    • Refused, Other formula products, n.e.c., powder formulaNUTR DEFEntry 799-0375066-2Source
    • Refused, Other formula products, n.e.c., powder formulaNUTR DEFEntry 799-0375066-2Source
    Source
  2. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaINCONSPICUFALSEEntry SCS-5424732-0
    Source
  3. Import refusal
    Refused, 5 lines in one entry: Infant formula raw material component, n.e.c.,INCONSPICUFALSENO ENGLISHEntry 799-1264832-8Show 5 lines
    Source
  4. Import refusal
    Refused, 4 lines in one entry: Milk base infant formula product (0-12 months), powder formulaLACK NOTIFINCONSPICULACKS N/CNO ENGLISHEntry 799-8160644-6Show 4 lines
    Source
  5. Import refusal
    Refused, Other formula products, n.e.c., ready to feedFALSENUTRIT LBLEntry 799-6791363-4
    Source
  6. Import refusal
    Refused, 4 lines in one entry: Milk base infant formula product (0-12 months), powder formulaLIST INGREFALSELACKS FIRMLACKS N/CEntry SCS-6709000-5Show 4 lines
    Source

2024

  1. Import refusal
    Refused, 2 lines in one entry: Milk base infant formula product (0-12 months), powder formulaLACKS N/CNO ENGLISHEntry SCS-6641379-4Show 2 lines
    Source
  2. Import refusal
    Refused, Toddler goat milk based formula/drink product (12-36 months), powder formulaNUTR DEFEntry 799-1175925-7
    Source
  3. Import refusal
    Refused, 2 lines in one entry: Milk base infant formula product (0-12 months), powder formulaNO ENGLISHLABELINGEntry SCS-3856598-6Show 2 lines
    Source
  4. Import refusal
    Refused, Oat cereal (baby)FALSENO ENGLISHEntry 799-0176433-3
    Source
  5. Import refusal
    Refused, Milk base infant formula product (0-12 months), ready to feedLIST INGRELACKS FIRMLACKS N/CEntry 799-7773347-6
    Source
  6. Import refusal
    Refused, 2 lines in one entry: Bran flakes,shredded and other forms ready to eat; Other formula products for sample testing (not for sale), n.e.c.NO ENGLISHFALSEALLERGENNUTR DEFEntry SCS-2315905-0Show 2 lines
    Source
  7. Import refusal
    Refused, Goat milk based infant formula product (0-12 months), ready to feedLIST INGRELACKS FIRMLACKS N/CNO ENGLISHNUTR DEFEntry 799-8385387-0
    Source
  8. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHNUTR DEFNUTR UNITEntry 799-7693532-0
    Source
  9. Import refusal
    Refused, Whey base infant formula product (0-12 months), powder formulaNO ENGLISHNUTR DEFNUTR UNITEntry 799-7692452-2
    Source

2023

  1. Import refusal
    Refused, Other formula products, n.e.c., powder formulaFALSEEntry SCS-7952002-2
    Source

2022

  1. Import refusal
    Refused, 2 lines in one entry: Milk base infant formula product (0-12 months), powder formulaINCONSPICULACKS FIRMLACKS N/CNUTR DEFEntry SCS-4828382-7Show 2 lines
    Source
  2. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry 799-0592132-6
    Source

2021

  1. Import refusal
    Refused, Baby and junior food n.e.c.LACKS N/CNUTRIT LBLEntry SCS-7704696-1
    Source
  2. Import refusal
    Refused, Baby and junior food n.e.c.LACKS N/CNUTRIT LBLEntry SCS-6454900-1
    Source
  3. Import refusal
    Refused, 3 lines in one entry: Cereal, n.e.c. (baby)NO ENGLISHNUTRIT LBLEntry SCS-6332359-8Show 3 lines
    Source
  4. Import refusal
    Refused, Teething biscuits (baby)NO ENGLISHEntry SCS-6541677-0
    Source
  5. Import refusal
    Refused, Processed fruit, juice and drink, n.e.c.LACKS N/CNO ENGLISHNUTRIT LBLNO PROCESSEntry SCS-6514057-8
    Source
  6. Import refusal
    Refused, Millet grain snack (whole, split), bakedLACKS N/CNO ENGLISHNUTRIT LBLEntry SCS-6464601-3
    Source
  7. Import refusal
    Refused, Baby and junior food n.e.c.LACKS N/CNUTRIT LBLNO PROCESSEntry SCS-6512849-0
    Source
  8. Import refusal
    Refused, Baby and junior food n.e.c.LACKS N/CNO ENGLISHNUTRIT LBLNO PROCESSEntry SCS-6514125-3
    Source
  9. Import refusal
    Refused, Baby and junior food n.e.c.LACKS N/CNO ENGLISHNUTRIT LBLNO PROCESSEntry SCS-6513490-2
    Source
  10. Import refusal
    Refused, Baby and junior food n.e.c.LACKS N/CNUTRIT LBLNO PROCESSEntry SCS-6196084-7
    Source
  11. Import refusal
    Refused, Novelty teas, n.e.c.LACKS N/CEntry SCS-6464601-3
    Source
  12. Import refusal
    Refused, Baby and junior food n.e.c.LACKS N/CNUTRIT LBLNO PROCESSEntry SCS-6422094-2
    Source
  13. Import refusal
    Refused, Teething biscuits (baby)LACKS N/CNUTRIT LBLEntry SCS-6464601-3
    Source
  14. Import refusal
    Refused, 2 lines in one entry: Baby and junior food n.e.c.NUTRIT LBLNEEDS FCENO PROCESSEntry SCS-6581027-9Show 2 lines
    Source

2020

  1. Import refusal
    Refused, Rice cereal (baby)NO ENGLISHEntry AEK-8111887-6
    Source

2019

  1. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry AEK-5407913-9
    Source
  2. Import refusal
    Refused, Oats, whole grainNO ENGLISHEntry SCS-4784016-1
    Source
  3. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSELACKS N/CEntry AEK-5607996-2
    Source

2018

  1. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry UPS-8435448-0
    Source
  2. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaNO ENGLISHEntry UPS-8435484-5
    Source
  3. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaLIST INGRELACKS N/CNO ENGLISHNUTRIT LBLEntry 799-5233219-2
    Source
  4. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaINCONSPICUNUTRIT LBLEntry AEK-4221680-1
    Source
  5. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaINCONSPICUNUTRIT LBLEntry AEK-4221632-2
    Source

2017

  1. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry AEK-3932301-6
    Source
  2. Import refusal
    Refused, Milk base infant formula product (0-12 months), powder formulaFALSEEntry AEK-3847136-0
    Source
  3. Import alert listing
    Listed on Import Alert 40-05red listHolle Organic Infant Follow-On Formula 2; Holle Goat Stage Pre Organic Infant Milk Formula (Holle Bio Pre Anfangsmilch aus Ziegenmilch)
    Source

2016

  1. Import alert listing
    Listed on Import Alert 99-39red listAnfangs-milch 1 (infant formula); Holle Organic Infant Follow-On Formula 2
    Source

Refusal charges, in plain English

  • NO ENGLISH44 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.

  • FALSE34 refused lines

    False or misleading labeling

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

  • LACKS N/C32 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 LBL30 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.

  • INCONSPICU20 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.

  • LACKS FIRM13 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.

  • LIST INGRE13 refused lines

    Ingredients not listed

    The product is made from two or more ingredients and the label appeared not to list the common or usual name of each one (or, for a juice beverage, the percentage of juice).

  • NUTR DEF11 refused lines

    NUTR DEF

Questions about Holle Baby Food GmbH

Is Holle Baby Food GmbH on an FDA import alert?
Yes. As of October 26, 2026, Holle Baby Food GmbH is on the red list of FDA Import Alert 40-05, “Adulterated and misbranded infant formula”, for holle organic infant follow-on formula 2; holle goat stage pre organic infant milk formula (holle bio pre anfangsmilch aus ziegenmilch); FDA published the listing on April 14, 2017.
Has FDA refused shipments from Holle Baby Food GmbH?
Yes. FDA refused 87 shipment lines from Holle Baby Food GmbH between October 4, 2017 and August 27, 2026. The most recent, on August 27, 2026, was milk base infant formula product (0-12 months), powder formula, charged as LACK NOTIF (lack notif).
Why did FDA refuse Holle Baby Food GmbH's shipments?
The most frequent charges are NO ENGLISH (required label information not in english, 44 lines) and FALSE (false or misleading labeling, 34 lines).
What is Holle Baby Food GmbH's FEI number?
Holle Baby Food GmbH's FDA Establishment Identifier (FEI) is 3011589751.
Can shipments from Holle Baby Food GmbH still enter the U.S.?
Shipments of holle organic infant follow-on formula 2; holle goat stage pre organic infant milk formula (holle bio pre anfangsmilch aus ziegenmilch) from Holle Baby Food GmbH 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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Example subjectHolle Baby Food Gmb 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.