Monthly digest
FDA import refusals and import alerts: December 2025
December 1, 2025 to December 31, 2025
In December 2025, FDA refused 984 imported shipment lines (up 14% vs November 2025), added 67 firm listings to import alerts and removed 0; India had the most refusals and UNSAFE COL (color additive unsafe under section 721) was the most common charge (as of October 26, 2026).
Data from FDA public records, last checked .
- 984
- shipment lines refused in December 2025
- +14%
- vs November 2025
- 67
- firm listings added to import alerts
- 0
- firm listings removed
November 2025
Counts can rise after publication because FDA's refusal data includes only final actions and is updated weekly. We recompute every month on each run.
January 2026Countries with the most FDA refusals in December 2025
Shipment lines refused, by country of origin. Each country links to its full refusal history.
| Country | Lines | Share of month |
|---|---|---|
| India | 267 | 27% |
| Mexico | 156 | 16% |
| China | 87 | 9% |
| Armenia | 35 | 4% |
| Nigeria | 35 | 4% |
| United Kingdom | 25 | 3% |
| Turkey | 25 | 3% |
| El Salvador | 23 | 2% |
| Guatemala | 22 | 2% |
| Indonesia | 20 | 2% |
Most common refusal charges in December 2025
FDA records one or more charge codes on every refused line, so counts can exceed the number of lines.
| Charge code | Meaning | Lines |
|---|---|---|
| UNSAFE COL | Color additive unsafe under section 721 | 174 |
| COLOR LBLG | Artificial coloring not declared | 130 |
| FSVP VIO | Importer not in compliance with FSVP | 119 |
| FILTHY | Filthy, putrid or decomposed substance | 112 |
| NUTRIT LBL | Nutrition information missing from label | 99 |
| SALMONELLA | Salmonella | 93 |
| UNAPPROVED | Unapproved new drug | 91 |
| POISONOUS | Poisonous or deleterious substance | 90 |
| PESTICIDE | Pesticide chemical residue | 85 |
| LACKS N/C | Net quantity statement missing | 53 |
Product categories refused in December 2025
| Category | Lines | Share of month |
|---|---|---|
| Snack Food Items | 175 | 18% |
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 114 | 12% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 107 | 11% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 79 | 8% |
| Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | 72 | 7% |
| Fishery/Seafood Products | 66 | 7% |
| Bakery Products, Doughs, Bakery Mixes, and Icings | 45 | 5% |
| Vegetables and Vegetable Products (root and tuber vegetables, fungi) | 38 | 4% |
| Multiple Food Dinners, Gravies, Sauces, and Specialties | 35 | 4% |
| Fruit and Fruit Products (berries, citrus and core fruits) | 28 | 3% |
Import alert changes in December 2025
67 firm listings added and 0 removed. Alerts with changes, most changes first.
| Alert | Covers | Added | Removed |
|---|---|---|---|
| 99-05 | Raw agricultural products for pesticides | 8 | |
| 45-02 | Foods containing illegal and/or undeclared colors | 7 | |
| 99-32 | Human and animal food products from foreign establishments | 7 | |
| 99-39 | Imported food products that appear to be misbranded | 7 | |
| 99-08 | Processed human and animal foods for pesticides | 6 | |
| 99-38 | Low-acid canned foods or acidified foods due to inadequate | 5 | |
| 16-119 | Fish and fishery products for importer and foreign processor | 4 | |
| 21-17 | Papaya from Mexico | 4 | |
| 99-42 | Foods due to heavy metal (toxic element) contamination | 3 | |
| 16-125 | Refrigerated (not frozen with proper labeling) raw fish | 2 | |
| 99-22 | Foods containing undeclared major food allergens or foods | 2 | |
| 99-43 | Ready-to-eat human food products that appear to have been | 2 | |
| 99-46 | Imported human foods due to filth | 2 | |
| 12-10 | Cheese due to microbiological contamination | 1 | |
| 16-120 | Fish and fishery products from foreign processors (mfrs.) | 1 | |
| 16-124 | Aquaculture seafood products due to unapproved drugs | 1 | |
| 16-129 | Seafood products due to nitrofurans | 1 | |
| 16-18 | Raw shrimp | 1 | |
| 16-81 | Seafood products due to the presence of Salmonella | 1 | |
| 99-23 | Produce due to contamination with human pathogens | 1 | |
| 99-35 | Fresh produce that appears to have been prepared, packed | 1 |
Firms with the most FDA records in December 2025
Counts are FDA records dated in the month (refusals, import alert listings and other events), not a ranking of quality.
| Firm | Country | Records in month |
|---|---|---|
| Bikanervala Foods Pvt. Ltd.Greater Noida | India | 64 |
| kirtiraj snacks pvt.ltdAnand | India | 41 |
| Ijevan Wine-Brandy FactoryIjevan | Armenia | 35 |
| Sabritas Planta CelayaCelaya | Mexico | 33 |
| Dulces Reni SA de CVGuadalajara | Mexico | 24 |
| Sichuan Savory Biotechnology Co., LtdChengdu | China | 17 |
| Swizzels Matlow LimitedHigh Peak | United Kingdom | 16 |
| Innovative Cuisine Pvt LtdVADODARA | India | 15 |
| Productos tipicos de centroamerica sa de cvSan Salvador | El Salvador | 14 |
| Hemmakvall ABLandskrona | Sweden | 14 |
Questions about December 2025
- How many shipments did FDA refuse in December 2025?
- FDA refused 984 imported food shipment lines in December 2025, compared with 861 in November 2025. Counts can rise after publication because FDA's refusal data includes only final actions and is updated weekly.
- Which countries had the most FDA refusals in December 2025?
- In December 2025, the countries with the most refused shipment lines were India (267), Mexico (156) and China (87).
- Which firms were added to FDA import alerts in December 2025?
- 67 firm listings were added to FDA import alerts in December 2025, most of them on Import Alert 99-05 (8), Import Alert 45-02 (7) and Import Alert 99-32 (7). Firms with the most FDA records among those active in the month include BIKANERVALA FOODS PVT. LTD., kirtiraj snacks pvt.ltd and IJEVAN WINE-BRANDY FACTORY. The alert changes are in the table on this page.
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