Import Alert 40-05: Detention without physical examination of adulterated and misbranded infant formula
As of October 26, 2026, FDA Import Alert 40-05 (Adulterated and misbranded infant formula) lists 17 firms on its red list in 9 countries, covering infant formula; 0 firms were added and 0 removed in the last 90 days.
Data from FDA public records, last checked . Request a correction
- 17
- firms on the red list
- 9
- countries
- 0
- added in the last 90 days
- 0
- removed in the last 90 days
What changed in the last 90 days
Removed from Import Alert 40-05
SupplierRadar has recorded no removals from Import Alert 40-05 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page, and on the firm's own page, the day it is found.
Added to Import Alert 40-05
No firm was added to Import Alert 40-05 in the last 90 days, as of October 26, 2026.
Firms on Import Alert 40-05, by country
Listings by country
| Country | Red list | Total |
|---|---|---|
| United Kingdom | 6 | 6 |
| Germany | 2 | 2 |
| Netherlands | 2 | 2 |
| Switzerland | 2 | 2 |
| Australia | 1 | 1 |
| France | 1 | 1 |
| India | 1 | 1 |
| Ireland | 1 | 1 |
| Israel | 1 | 1 |
United Kingdom (6)
FDA refusals from United Kingdom| Firm | List | Products | Date published |
|---|---|---|---|
| BritsuperstoreDover | Red | HiPP Organic Good Night Milk; HiPP Organic Combiotic Anti-Reflux Milk Powder | |
| HippHurst Grove | Red | HiPP Organic Combiotic anti-reflux milk powder; HiPP Organic Good Night milk; Combiotic First Infant Milk | |
| Hipp Uk LtdBerkshire | Red | HiPP Organic Combiotic Hungry Infant Milk; HiPP Organic Combiotic First Infant Milk; Combiotic Follow On Milk | |
| Kendal Nutricare Ltd.Kendal | Red | First Infant Milk | |
| NannycareLondon | Red | Follow on Milk | |
| NutriciaWilshire | Red | Aptamil Breast Milk Substitute |
Germany (2)
FDA refusals from Germany| Firm | List | Products | Date published |
|---|---|---|---|
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm | Red | HiPP Combiotic PRE Infant Milk | |
| Milchwerke "Mittelelbe" GmbHStendal | Red | Powdered Infant Formula |
Netherlands (2)
FDA refusals from Netherlands| Firm | List | Products | Date published |
|---|---|---|---|
| JoannusmolenCuijk | Red | EkoBaby Zuigelingenmelk 1; EkoBaby Groeimelk 3; EkoBaby Opvolgmelk 2 | |
| Potentia Trium B.VRotterdam | Red | Loulouka Goat Follow-On Formula |
Switzerland (2)
FDA refusals from Switzerland| Firm | List | Products | Date published |
|---|---|---|---|
| Holle Baby Food GmbHRiehen | Red | Holle Organic Infant Follow-On Formula 2; Holle Goat Stage Pre Organic Infant Milk Formula (Holle Bio Pre Anfangsmilch a | |
| Holle FoodRiehen | Red | Holle Organic Infant Formula Bio-Folgemilch 2; Holle Organic Infant Powder Formula Bio 1 |
Australia (1)
FDA refusals from Australia| Firm | List | Products | Date published |
|---|---|---|---|
| Mainfreight Warehousing Dandenong SouthDandenong South | Red | LittleOak Natural Goat Milk Follow-on Formula (6-12 months); LittleOak Natural Goat Milk Infant Formula 1 (0-6 months) |
France (1)
FDA refusals from France| Firm | List | Products | Date published |
|---|---|---|---|
| Nutribio, SAMontauban | Red | Milk Base Infant Formula Product (0-12 months), Powder Formula |
India (1)
FDA refusals from India| Firm | List | Products | Date published |
|---|---|---|---|
| Nestle India LtdNew Delhi | Red | Formula Prod (Baby); Infant Formula Raw Material; Ready To Feed Formula Products; Liquid Concentrate Formula Products; P |
Ireland (1)
FDA refusals from Ireland| Firm | List | Products | Date published |
|---|---|---|---|
| NutriciaDublin 1 | Red | First Infant Milk |
Israel (1)
FDA refusals from Israel| Firm | List | Products | Date published |
|---|---|---|---|
| Maabarot Products Ltd.Ma'Abarot | Red | Formula Prod (Baby); Ready To Feed Formula Products; Liquid Concentrate Formula Products; Powder Formula Products |
Refusal charges named on this alert
| Charge code | Meaning | Refusal lines since 2016 |
|---|---|---|
| LIST INGRE | Ingredients not listed | 6,329 |
| LACKS N/C | Net quantity statement missing | 5,566 |
| LACKS FIRM | Manufacturer name and address missing | 3,082 |
| USUAL NAME | Common or usual name missing | 2,547 |
| FALSE | False or misleading labeling | 2,446 |
| POISONOUS | Poisonous or deleterious substance | 2,420 |
| ALLERGEN | Major food allergen not declared | 1,736 |
| INSANITARY | Prepared, packed or held under insanitary conditions | 898 |
| NUTR DEF | The infant formula appears to adulterated in that it does not provide the nutrients required by 21 CFR 107.100 | 25 |
| NUTR UNIT | The infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to… | 20 |
What the alert covers and why FDA issued it
- Official title
- DETENTION WITHOUT PHYSICAL EXAMINATION OF ADULTERATED AND MISBRANDED INFANT FORMULA
- Product scope
- Infant formula
- Last published
Since an infant formula shortage in early 2022, the U.S. Food and Drug Administration (FDA or the Agency) and U.S. government partners have been working to expand consumer access to infant formula products, while also ensuring that these products are safe and nutritionally adequate. As we emerged from the acute crisis, the agency has participated in numerous reviews, including an evaluation of the agencys infant formula response.
FDA has taken many steps to improve the resiliency of the infant formula supply, including by issuing multiple guidance documents intended to help facilitate the availability of safe and nutritionally adequate infant formula products in the U.S. marketplace. The agency has also taken steps to enhance the safety of powdered infant formula through the development of a Cronobacter prevention strategy, enhanced inspectional activities, increased engagement with the infant formula industry, and by pursuing regulatory action when appropriate. The revision of this import alert aligns with the Agencys ongoing commitment to enhance regulatory oversight to help ensure that the industry is producing infant formula under the safest conditions possible.
Read the rest of the reason
This import alert addresses infant formulas that appear to be adulterated and/or misbranded. A detention recommendation case should be forwarded to Human Food Program Division of Produce and Imports Enforcement, Imports Enforcement Branch.
Listing on an import alert is FDA's notice to the firm and a fact an importer must consider in its supplier evaluation under 21 CFR 1.505. What the red, green and yellow lists mean.
Questions about Import Alert 40-05
- What is Import Alert 40-05?
- Import Alert 40-05, “Detention without physical examination of adulterated and misbranded infant formula”, is an FDA import alert. FDA may detain infant formula from the firms on its red list without physical examination; FDA last published the alert on July 21, 2026.
- Which firms are on Import Alert 40-05?
- As of October 26, 2026, 17 firms are listed on Import Alert 40-05 in 9 countries; the most listings are in United Kingdom (6), Germany (2) and Netherlands (2). The full table, grouped by country, is below on this page and every firm links to its record.
- How do firms get off Import Alert 40-05?
- A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 40-05; our guide explains the steps and the evidence FDA usually asks for.
- What charge does FDA use under Import Alert 40-05?
- The charge section of Import Alert 40-05 names LIST INGRE (ingredients not listed), LACKS N/C (net quantity statement missing), LACKS FIRM (manufacturer name and address missing), USUAL NAME (common or usual name missing) and FALSE (false or misleading labeling) and 5 more. Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.
- Which firms were added to Import Alert 40-05 recently?
- No firm was added to Import Alert 40-05 in the last 90 days, as of October 26, 2026.
- Which firms were removed from Import Alert 40-05 recently?
- SupplierRadar has recorded no removals from Import Alert 40-05 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page and on the firm's page the day it is found.
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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.