FDA refusal charge
FDA refusal charge NUTR UNIT
NUTR UNIT is the FDA import refusal charge for the infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to…; it cites sections 403(f) and 801(a)(3) of the FD&C Act (misbranded). FDA recorded it on 20 refused shipment lines from 7 countries between October 2016 and August 18, 2026, most often for baby food from Germany.
Data from FDA public records, last checked .
- 20
- refused shipment lines carry this charge
- 7
- countries of origin
- 1
- import alert names this charge
What NUTR UNIT means
SupplierRadar has not written a plain-English version of NUTR UNIT yet. FDA's own statement is quoted below.
- FD&C Act section
- 403(f)801(a)(3)
- Classification
- misbranded
FDA's official statement
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to use the proper units to declare the nutrients as specified in 21 CFR 107.10.
Import alerts that name NUTR UNIT
| Alert | Covers | Red | Green |
|---|---|---|---|
| 40-05 | Adulterated and misbranded infant formula | 17 |
Countries with the most NUTR UNIT refusals
| Country | Lines | Share of NUTR UNIT |
|---|---|---|
| Germany | 5 | 25% |
| United Kingdom | 5 | 25% |
| Switzerland | 4 | 20% |
| Ghana | 2 | 10% |
| Netherlands | 2 | 10% |
| Austria | 1 | 5% |
| New Zealand | 1 | 5% |
Product categories with the most NUTR UNIT refusals
| Category | Lines | Share of NUTR UNIT |
|---|---|---|
| Baby (Infant and Junior) Food Products | 19 | 95% |
| Filled Milk and Imitation Milk Products | 1 | 5% |
Latest NUTR UNIT refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Kendal Nutricare Ltd.Kendal, United Kingdom | Milk base infant formula product (0-12 months), powder formula | NUTR DEFNUTR UNIT | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), powder formula | NO ENGLISHNUTR DEFNUTR UNIT | Source | |
| Agrana Zucker GmbhVienna, Austria | Goat milk infant based formula product (0-12 months), powder formula | LACK NOTIFINCONSPICUNO ENGLISH+2 | Source | |
| Kendal Nutricare Ltd.Kendal, United Kingdom | Other formula products, n.e.c., ready to feed | FALSENUTR UNIT | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Other formula products, n.e.c., ready to feed | NUTR UNIT | Source | |
| Holle FoodRiehen, Switzerland | Milk base infant formula product (0-12 months), powder formula | NO ENGLISHNUTR UNIT | Source | |
| Holle Baby Food GmbHRiehen, Switzerland | Other formula products for sample testing (not for sale), n.e.c | FALSEALLERGENNUTR DEF+1 | Source | |
| Sam BodeIttervoort, Netherlands | Milk base infant formula product (0-12 months), powder formula | INCONSPICUNUTR UNITNUTRIT LBL | Source | |
| Holle Baby Food GmbHRiehen, Switzerland | Milk base infant formula product (0-12 months), powder formula | NO ENGLISHNUTR DEFNUTR UNIT | Source | |
| Holle Baby Food GmbHRiehen, Switzerland | Whey base infant formula product (0-12 months), powder formula | NO ENGLISHNUTR DEFNUTR UNIT | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), powder formula | NO ENGLISHNUTR UNITNUTRIT LBL | Source | |
| Kendal Nutricare Ltd.Kendal, United Kingdom | Milk base infant formula product (0-12 months), powder formula | NUTR UNITNUTRIT LBL | Source | |
| HippHurst Grove, United Kingdom | Milk base infant formula product (0-12 months), powder formula | LIST INGREFALSELACKS FIRM+5 | Source | |
| NIG Nutritionals Limited - PaerataPukekohe, New Zealand | Milk base infant formula product (0-12 months), powder formula | LACK NOTIFNUTR UNIT | Source | |
| Lisa ScholtenIttervoort, Netherlands | Filled milk, dried milk type product | LIST INGREFALSELACKS FIRM+5 | Source | |
| Kendal Nutricare Ltd.Kendal, United Kingdom | Milk base infant formula product (0-12 months), powder formula | ALLERGENNUTR DEFNUTR UNIT | Source | |
| German Nutrition GmbHMunich, Germany | Milk base infant formula product (0-12 months), powder formula | LIST INGREFALSELACKS FIRM+5 | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Baby and junior food n.e.c | NUTR DEFNUTR UNIT | Source | |
| Nestle (Gh) LtdNorth Dzorwulu, Ghana | Cereal, n.e.c. (baby) | LIST INGREFALSELACKS N/C+4 | Source | |
| Nestle (Gh) LtdNorth Dzorwulu, Ghana | Cereal, n.e.c. (baby) | LIST INGREFALSELACKS N/C+4 | Source |
Questions about NUTR UNIT
- What does NUTR UNIT mean on an FDA refusal?
- NUTR UNIT is the refusal charge “The infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to…”. FDA's official statement for the charge reads: “The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the infant formula appears to be misbranded within the meaning of Section 403 in that the labeling fails to use the proper units to declare the nutrients as specified in 21 CFR 107.10.”
- What law does NUTR UNIT cite?
- FDA's refusal charge table cites sections 403(f) and 801(a)(3) of the FD&C Act (misbranded) for NUTR UNIT, and classifies the charge as misbranded. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
- Which countries have the most NUTR UNIT refusals?
- As of October 26, 2026, the countries with the most NUTR UNIT refusal lines are Germany (5), United Kingdom (5) and Switzerland (4). The full list with links is in the table on this page.
- Is there an FDA import alert for NUTR UNIT?
- Yes. One FDA import alert names NUTR UNIT as a charge code, including Import Alert 40-05 (Adulterated and misbranded infant formula). An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.
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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.