Monthly digest
FDA import refusals and import alerts: November 2025
November 1, 2025 to November 30, 2025
In November 2025, FDA refused 861 imported shipment lines (down 32% vs October 2025), added 38 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 25, 2026).
Data from FDA public records, last checked .
- 861
- shipment lines refused in November 2025
- −32%
- vs October 2025
- 38
- firm listings added to import alerts
- 0
- firm listings removed
October 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.
December 2025Countries with the most FDA refusals in November 2025
Shipment lines refused, by country of origin. Each country links to its full refusal history.
Most common refusal charges in November 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 | 176 |
| COLOR LBLG | Artificial coloring not declared | 124 |
| FILTHY | Filthy, putrid or decomposed substance | 101 |
| NO PROCESS | No scheduled process filed | 75 |
| UNAPPROVED | Unapproved new drug | 74 |
| MFR INSAN | Insanitary manufacturing, processing or packing | 73 |
| NUTRIT LBL | Nutrition information missing from label | 72 |
| MELAMINE | Melamine | 57 |
| PESTICIDE | Pesticide chemical residue | 56 |
| SALMONELLA | Salmonella | 52 |
Product categories refused in November 2025
| Category | Lines | Share of month |
|---|---|---|
| Snack Food Items | 115 | 13% |
| Fishery/Seafood Products | 82 | 10% |
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 80 | 9% |
| Bakery Products, Doughs, Bakery Mixes, and Icings | 79 | 9% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 66 | 8% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 56 | 7% |
| Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | 50 | 6% |
| Spices, Flavors, and Salts | 37 | 4% |
| Nuts and Edible Seeds | 34 | 4% |
| Vegetables and Vegetable Products (root and tuber vegetables, fungi) | 33 | 4% |
Import alert changes in November 2025
38 firm listings added and 0 removed. Alerts with changes, most changes first.
| Alert | Covers | Added | Removed |
|---|---|---|---|
| 99-08 | Processed human and animal foods for pesticides | 10 | |
| 45-02 | Foods containing illegal and/or undeclared colors | 4 | |
| 99-32 | Human and animal food products from foreign establishments | 3 | |
| 99-37 | Low-acid canned foods and acidified foods without filed | 3 | |
| 16-04 | Seafood products that appear to be misbranded | 2 | |
| 16-35 | Raw and cooked shrimp from India | 2 | |
| 16-74 | Uneviscerated fish or partially eviscerated fish | 2 | |
| 99-39 | Imported food products that appear to be misbranded | 2 | |
| 99-43 | Ready-to-eat human food products that appear to have been | 2 | |
| 16-125 | Refrigerated (not frozen with proper labeling) raw fish | 1 | |
| 20-07 | Juice from foreign processors not in compliance with juice | 1 | |
| 21-17 | Papaya from Mexico | 1 | |
| 33-15 | Mini-cup gel and jelly candies of firm consistency | 1 | |
| 99-19 | Food products due to the presence of Salmonella | 1 | |
| 99-38 | Low-acid canned foods or acidified foods due to inadequate | 1 | |
| 99-42 | Foods due to heavy metal (toxic element) contamination | 1 | |
| 99-45 | Food products that are or contain an unsafe food additive | 1 |
Firms with the most FDA records in November 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 |
|---|---|---|
| Shwe Hinthar Yeik Mon Co., LtdYangon | Myanmar | 54 |
| Innovative Cuisine Pvt LtdVADODARA | India | 40 |
| Sabritas Planta CelayaCelaya | Mexico | 32 |
| Comercializadora Pepsico Mexico,Ciudad De Mexico | Mexico | 26 |
| Swizzels Matlow LimitedHigh Peak | United Kingdom | 22 |
| Mado PasticcerieBari | Italy | 14 |
| Shandong Binzhou Jonnic Food Co., LtdBinzhou | China | 12 |
| Chengdu Yuanxian Food Co., LtdChendu | China | 12 |
| Sabritas S. de R.L. de C.V. Planta SaltilloSaltillo | Mexico | 11 |
| Sabritas S.A. de C.V.Saltillo | Mexico | 11 |
Questions about November 2025
- How many shipments did FDA refuse in November 2025?
- FDA refused 861 imported food shipment lines in November 2025, compared with 1,261 in October 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 November 2025?
- In November 2025, the countries with the most refused shipment lines were India (141), China (136) and Mexico (132).
- Which firms were added to FDA import alerts in November 2025?
- 38 firm listings were added to FDA import alerts in November 2025, most of them on Import Alert 99-08 (10), Import Alert 45-02 (4) and Import Alert 99-32 (3). Firms with the most FDA records among those active in the month include Shwe Hinthar Yeik Mon Co., Ltd, Innovative Cuisine Pvt Ltd and SABRITAS PLANTA CELAYA. The alert changes are in the table on this page.
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