FDA import refusals
FDA import refusals: baby food from Germany
FDA refused 149 baby food shipment lines from Germany between October 2016 and October 2, 2026, 28 of them in 2026; the most refused products were milk base infant formula product and baby and junior food n.e.c., most often for NO ENGLISH (required label information not in English).
Data from FDA public records, last checked .
- 149
- baby food lines refused since October 2016
- 28
- refused so far in 2026
- 3
- firms with the most records, listed below
Baby food refusals from Germany by year
| Year | Refusal lines | vs prior year |
|---|---|---|
| 2026 (to date) | 28 | |
| 2025 | 26 | +37% |
| 2024 | 19 | +375% |
| 2023 | 4 | +33% |
| 2022 | 3 | -40% |
| 2021 | 5 | +25% |
| 2020 | 4 | -67% |
| 2019 | 12 | +71% |
| 2018 | 7 | -81% |
| 2017 | 37 | |
| 2016 (from Oct) | 4 |
Milk base infant formula product refusals from Germany
| FDA product description | Lines | Share of baby food |
|---|---|---|
| Milk base infant formula product (0-12 months), powder formula | 81 | 54.4% |
| Milk base infant formula product (0-12 months), ready to feed | 20 | 13.4% |
Recent milk base infant formula product refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Milchwerke "Mittelelbe" GmbHStendal, Germany | Milk base infant formula product (0-12 months), powder formula | INSANITARY | Source | |
| Milchwerke "Mittelelbe" GmbHStendal, Germany | Milk base infant formula product (0-12 months), powder formula | INSANITARY | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), ready to feed | LACK NOTIFFALSENO ENGLISH | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), powder formula | INCONSPICULACKS N/C | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), powder formula | INCONSPICULACKS N/C | Source |
Baby and junior food n.e.c. refusals from Germany
| FDA product description | Lines | Share of baby food |
|---|---|---|
| Baby and junior food n.e.c. | 17 | 11.4% |
Other formula products refusals from Germany
| FDA product description | Lines | Share of baby food |
|---|---|---|
| Other formula products, n.e.c., ready to feed | 8 | 5.4% |
| Other formula products, n.e.c., powder formula | 6 | 4.0% |
Recent other formula products refusals
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Other formula products, n.e.c., ready to feed | LABELING | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Other formula products, n.e.c., ready to feed | FALSE | Source |
Other baby food products refused from Germany
| Product group | Lines | Share |
|---|---|---|
| Infant formula raw material component | 4 | 2.7% |
| Goat milk infant based formula product | 2 | 1.3% |
| Instant cereal made with formula | 2 | 1.3% |
| Vegetables | 2 | 1.3% |
| Wheat cereal | 2 | 1.3% |
Why FDA refused baby food from Germany
| Charge code | Meaning | Lines | Share |
|---|---|---|---|
| NO ENGLISH | Required label information not in English | 84 | 28% |
| LACKS N/C | Net quantity statement missing | 47 | 16% |
| FALSE | False or misleading labeling | 43 | 15% |
| NUTRIT LBL | Nutrition information missing from label | 40 | 14% |
| INCONSPICU | Required information not conspicuous | 21 | 7% |
| LACK NOTIF | Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification… | 16 | 5% |
| USUAL NAME | Common or usual name missing | 15 | 5% |
| ALLERGEN | Major food allergen not declared | 14 | 5% |
| LABELING | Fair Packaging and Labeling Act | 8 | 3% |
| LACKS FIRM | Manufacturer name and address missing | 7 | 2% |
Import alerts for baby food that list Germany firms
| Alert | Covers | Red | Green |
|---|---|---|---|
| 40-05 | Adulterated and misbranded infant formula | 2 |
Germany baby food firms with the most FDA records
| Firm | City | FDA records |
|---|---|---|
| Hipp GmbH & CO Vertrieb KG | Pfaffenhofen A.d.ilm | 123 |
| Organic Baby Food GmbH | Hanover | 7 |
| Milchwerke "Mittelelbe" GmbH | Stendal | 2 |
Latest baby food refusals from Germany
| Date | Firm | Product | Charges | |
|---|---|---|---|---|
| Holle Europe GmbHLorrach, Germany | Goat milk infant based formula product (0-12 months), powder formula | LIST INGREFALSELACKS N/C | Source | |
| Milchwerke "Mittelelbe" GmbHStendal, Germany | Milk base infant formula product (0-12 months), powder formula | INSANITARY | Source | |
| Milchwerke "Mittelelbe" GmbHStendal, Germany | Milk base infant formula product (0-12 months), powder formula | INSANITARY | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), ready to feed | LACK NOTIFFALSENO ENGLISH | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), powder formula | INCONSPICULACKS N/C | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), powder formula | INCONSPICULACKS N/C | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Vegetables, n.e.c. (baby) | NEEDS FCENO PROCESS | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Vegetables, n.e.c. (baby) | NEEDS FCENO PROCESS | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Fruit flavored drink | NEEDS FCENO PROCESS | 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 | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), powder formula | LACK NOTIFNO ENGLISHNUTRIT LBL | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), powder formula | LACKS N/CNO ENGLISH | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), powder formula | LACKS N/CNO ENGLISH | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), ready to feed | NUTRIT LBL | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Other formula products, n.e.c., ready to feed | LABELING | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), ready to feed | LABELING | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Whey base infant formula product (0-12 months), ready to feed | FALSENO ENGLISH | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Other formula products, n.e.c., ready to feed | FALSE | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), powder formula | FALSE | Source | |
| Hipp GmbH & CO Vertrieb KGPfaffenhofen A.d.ilm, Germany | Milk base infant formula product (0-12 months), powder formula | LACK NOTIFINCONSPICUNO ENGLISH | Source |
Questions about baby food refusals from Germany
- How many baby food shipments from Germany did FDA refuse in 2026?
- FDA refused 28 shipment lines of baby food from Germany in 2026 through October 2, 2026, compared with 26 in 2025.
- Why does FDA refuse baby food from Germany?
- FDA records a charge code on every refused shipment line. For baby food from Germany the most frequent are NO ENGLISH (required label information not in English, 84 lines), LACKS N/C (net quantity statement missing, 47 lines) and FALSE (false or misleading labeling, 43 lines). A charge describes what FDA's reference table says about one shipment line, not about every firm.
- Which import alerts cover baby food from Germany?
- As of October 26, 2026, the FDA import alerts for this category that list Germany firms are Import Alert 40-05 (2 firms). General food alerts numbered 99-xx can list Germany firms too; see the country page.
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