FDA import alert
Import Alert 40-05
***�DETENTION WITHOUT PHYSICAL EXAMINATION OF ADULTERATED AND MISBRANDED INFANT FORMULA"***
19
Red-list entries
0
Green-list entries
9
Countries
2026-07-21
Last change seen
What being on this list means
Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →
A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.
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Red-list entries by country
| Country | Entries |
|---|---|
| United Kingdom | 7 |
| Switzerland | 3 |
| Germany | 2 |
| Netherlands | 2 |
| Australia | 1 |
| France | 1 |
| India | 1 |
| Ireland | 1 |
| Israel | 1 |
Firms on this red list
Showing 19 of 19 entries — search a specific firm on the free checker.
- Mainfreight Warehousing Dandenong South
11/16/2023
Australia · Fluid/Dry Milk Products Not Elsewhere Mentioned, N.E.C.; Milk Base Infant Formula Product (0-12 months), Powder Formula; Other Formula Products, N.E.C., Powder Formula
- Nutribio, SA
07/21/2026
France · Milk Base Infant Formula Product (0-12 months), Powder Formula
- Hipp GmbH & CO Vertrieb KG
04/03/2019
Germany · Milk Base Infant Formula Product (0-12 months), Ready to Feed; Other Formula Products, N.E.C., Ready to Feed; Baby and Junior Food N.E.C.
- Milchwerke "Mittelelbe" GmbH
06/26/2026
Germany · Milk Base Infant Formula Product (0-12 months), Powder Formula
- Nestle India Ltd
10/15/2021
India · Formula Prod (Baby); Infant Formula Raw Material; Ready To Feed Formula Products
- Nutricia
05/10/2017
Ireland · Ready To Feed Formula Products
- Maabarot Products Ltd.
09/18/2009
Israel · Formula Prod (Baby); Ready To Feed Formula Products; Liquid Concentrate Formula Products
- JOANNUSMOLEN
09/20/2018
Netherlands · Infant Formula Raw Material; Ready To Feed Formula Products; Liquid Concentrate Formula Products
- Potentia Trium B.V
11/15/2021
Netherlands · Milk Base Infant Formula Product (0-12 months), Powder Formula; Other Formula Products, N.E.C., Powder Formula
- HOLLE FOOD
02/13/2017
Switzerland · Infant Formula Raw Material Component, N.E.C.,; Milk Base Infant Formula Product (0-12 months), Ready to Feed; Other Formula Products, N.E.C., Ready to Feed
- Holle Baby Food GmbH
04/14/2017
Switzerland · Instant Cereal Made With Formula (Baby); Infant Formula Raw Material Component, N.E.C.,; Milk Base Infant Formula Product (0-12 months), Ready to Feed
- Holle Baby Food GmbH
05/10/2024
Switzerland · Milk Base Infant Formula Product (0-12 months), Powder Formula; Potassium (Mineral)
- Britsuperstore
06/06/2017
United Kingdom · Milk Base Infant Formula Product (0-12 months), Powder Formula
- Hipp
06/06/2017
United Kingdom · Milk Base Infant Formula Product (0-12 months), Powder Formula
- Hipp
05/10/2017
United Kingdom · Ready To Feed Formula Products
- Hipp Uk Ltd
04/05/2016
United Kingdom · Other Formula Products, N.E.C., Ready to Feed; Milk Base Infant Formula Product (0-12 months), Powder Formula
- Kendal Nutricare Ltd.
12/15/2017
United Kingdom · Milk Base Infant Formula Product (0-12 months), Powder Formula
- Nannycare
05/09/2017
United Kingdom · Goat Milk; Baby Food Products
- Nutricia
09/15/2015
United Kingdom · Baby and Junior Food N.E.C.
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