Monthly digest
FDA import refusals and import alerts: September 2025
September 1, 2025 to September 30, 2025
In September 2025, FDA refused 1,472 imported shipment lines (up 23% vs August 2025), added 57 firm listings to import alerts and removed 0; India had the most refusals and MFR INJ (insanitary conditions, may be injurious) was the most common charge (as of October 25, 2026).
Data from FDA public records, last checked .
- 1,472
- shipment lines refused in September 2025
- +23%
- vs August 2025
- 57
- firm listings added to import alerts
- 0
- firm listings removed
August 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.
October 2025Countries with the most FDA refusals in September 2025
Shipment lines refused, by country of origin. Each country links to its full refusal history.
| Country | Lines | Share of month |
|---|---|---|
| India | 380 | 26% |
| Indonesia | 356 | 24% |
| Mexico | 145 | 10% |
| China | 106 | 7% |
| Canada | 57 | 4% |
| Guatemala | 49 | 3% |
| United Kingdom | 42 | 3% |
| Philippines | 41 | 3% |
| Taiwan | 40 | 3% |
| South Korea | 25 | 2% |
Most common refusal charges in September 2025
FDA records one or more charge codes on every refused line, so counts can exceed the number of lines.
| Charge code | Meaning | Lines |
|---|---|---|
| MFR INJ | Insanitary conditions, may be injurious | 463 |
| MFR INSAN | Insanitary manufacturing, processing or packing | 246 |
| UNSAFE COL | Color additive unsafe under section 721 | 188 |
| COLOR LBLG | Artificial coloring not declared | 144 |
| NUTRIT LBL | Nutrition information missing from label | 138 |
| POISONOUS | Poisonous or deleterious substance | 122 |
| UNAPPROVED | Unapproved new drug | 111 |
| SALMONELLA | Salmonella | 107 |
| FILTHY | Filthy, putrid or decomposed substance | 98 |
| PESTICIDE | Pesticide chemical residue | 97 |
Product categories refused in September 2025
| Category | Lines | Share of month |
|---|---|---|
| Fishery/Seafood Products | 453 | 31% |
| Candy without Chocolate, Candy Specialties, and Chewing Gum | 139 | 9% |
| Snack Food Items | 123 | 8% |
| Vitamins, Minerals, Proteins, and Unconventional Dietary Specialties | 116 | 8% |
| Vegetables and Vegetable Products (legumes, leaf and stem, fruit vegetables) | 101 | 7% |
| Fruit and Fruit Products (pit, subtropical and tropical fruits) | 66 | 4% |
| Bakery Products, Doughs, Bakery Mixes, and Icings | 63 | 4% |
| Multiple Food Dinners, Gravies, Sauces, and Specialties | 58 | 4% |
| Vegetables and Vegetable Products (root and tuber vegetables, fungi) | 52 | 4% |
| Spices, Flavors, and Salts | 52 | 4% |
Import alert changes in September 2025
57 firm listings added and 0 removed. Alerts with changes, most changes first.
| Alert | Covers | Added | Removed |
|---|---|---|---|
| 45-02 | Foods containing illegal and/or undeclared colors | 8 | |
| 99-08 | Processed human and animal foods for pesticides | 8 | |
| 99-05 | Raw agricultural products for pesticides | 6 | |
| 16-120 | Fish and fishery products from foreign processors (mfrs.) | 3 | |
| 16-74 | Uneviscerated fish or partially eviscerated fish | 3 | |
| 25-05 | Dried fungus (mushrooms) from Hong Kong and PROC for filth | 3 | |
| 16-50 | Molluscan bivalve shellfish | 2 | |
| 16-81 | Seafood products due to the presence of Salmonella | 2 | |
| 99-23 | Produce due to contamination with human pathogens | 2 | |
| 99-38 | Low-acid canned foods or acidified foods due to inadequate | 2 | |
| 99-39 | Imported food products that appear to be misbranded | 2 | |
| 99-42 | Foods due to heavy metal (toxic element) contamination | 2 | |
| 16-04 | Seafood products that appear to be misbranded | 1 | |
| 16-119 | Fish and fishery products for importer and foreign processor | 1 | |
| 16-124 | Aquaculture seafood products due to unapproved drugs | 1 | |
| 16-125 | Refrigerated (not frozen with proper labeling) raw fish | 1 | |
| 16-35 | Raw and cooked shrimp from India | 1 | |
| 22-01 | Cantaloupes from Mexico | 1 | |
| 33-15 | Mini-cup gel and jelly candies of firm consistency | 1 | |
| 54-14 | Dietary supplement products from firms that have not met | 1 | |
| 54-16 | Products that are marketed as foods, including products | 1 | |
| 99-22 | Foods containing undeclared major food allergens or foods | 1 | |
| 99-37 | Low-acid canned foods and acidified foods without filed | 1 | |
| 99-43 | Ready-to-eat human food products that appear to have been | 1 | |
| 99-47 | Human food products that appear to be adulterated | 1 |
Firms with the most FDA records in September 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 |
|---|---|---|
| PT. Bahari Makmur SejatiSerang | Indonesia | 346 |
| Innovative Cuisine Pvt LtdVADODARA | India | 127 |
| Labixiaoxin (Fujian) Foods Industrial Company LimitedQuanzhou | China | 60 |
| Swizzels Matlow LimitedHigh Peak | United Kingdom | 40 |
| Quality Spices & Food Exports Pvt.Ltd.Ambernath (E) | India | 40 |
| Tsang Lin Industries Corp.Taichung | Taiwan | 36 |
| Sabritas Planta CelayaCelaya | Mexico | 34 |
| Nutri-Asia, IncorporatedCabuyao | Philippines | 32 |
| Gurulucky Snacks & SweetsSurrey | Canada | 29 |
| Societe de Conserverie En Afrique (Sca S.A.)Dakar | Senegal | 22 |
Questions about September 2025
- How many shipments did FDA refuse in September 2025?
- FDA refused 1,472 imported food shipment lines in September 2025, compared with 1,195 in August 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 September 2025?
- In September 2025, the countries with the most refused shipment lines were India (380), Indonesia (356) and Mexico (145).
- Which firms were added to FDA import alerts in September 2025?
- 57 firm listings were added to FDA import alerts in September 2025, most of them on Import Alert 45-02 (8), Import Alert 99-08 (8) and Import Alert 99-05 (6). Firms with the most FDA records among those active in the month include PT. Bahari Makmur Sejati, Innovative Cuisine Pvt Ltd and Labixiaoxin (Fujian) Foods Industrial Company Limited. The alert changes are in the table on this page.
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