FDA import refusals and alerts by country
From 2025-10 to 2026-09, FDA refused 18,224 import lines from these 20 countries. India had the most refusals (5,683), followed by China and Mexico. Figures come from FDA's Import Refusal Report, import alert lists and openFDA, updated monthly. Free to cite with a link.
| Country | Refused lines | Top refusal charge | Import alerts listing firms | Recalls, 5 yrs (food / device / drug) |
|---|---|---|---|---|
| India | 5,683 | UNAPPROVED-75 | 58 | 8 / 10 / 222 |
| China | 2,749 | TP NO PMTA-3842 | 85 | 10 / 208 / 33 |
| Mexico | 2,427 | UNSAFE COL-11 | 70 | 33 / 3 / 0 |
| South Korea | 1,347 | NOT LISTED-118 | 51 | 3 / 28 / 5 |
| Canada | 931 | UNAPPROVED-75 | 57 | 92 / 47 / 20 |
| United Kingdom | 644 | UNSAFE COL-11 | 38 | 0 / 143 / 1 |
| Germany | 512 | NOT LISTED-118 | 35 | 0 / 211 / 0 |
| Indonesia | 440 | 801CERTREQ-3910 | 34 | 0 / 0 / 0 |
| Thailand | 418 | FILTHY-249 | 50 | 0 / 0 / 0 |
| France | 408 | NOT LISTED-118 | 30 | 0 / 68 / 0 |
| Pakistan | 407 | DE IMP GMP-290 | 26 | 1 / 0 / 0 |
| Brazil | 401 | UNAPPROVED-75 | 35 | 0 / 3 / 0 |
| Vietnam | 397 | NOT LISTED-118 | 44 | 0 / 0 / 8 |
| Japan | 283 | NOT LISTED-118 | 42 | 0 / 71 / 5 |
| Italy | 273 | NOT LISTED-118 | 38 | 3 / 29 / 0 |
| Taiwan | 266 | UNFIT4FOOD-3422 | 46 | 1 / 15 / 4 |
| Turkey | 259 | UNSAFE COL-11 | 31 | 0 / 1 / 0 |
| Spain | 191 | UNAPPROVED-75 | 32 | 6 / 58 / 1 |
| Malaysia | 123 | NO 510(K)-508 | 39 | 0 / 0 / 0 |
| Israel | 65 | UNAPPROVED-75 | 21 | 82 / 90 / 0 |
Data retrieved 2026-10-21. Recalls are counted by the recalling firm's country. Refusal lines are entry lines, not shipments. License: CC BY 4.0. Cite as "US Agent Desk analysis of FDA data".
Also: New FCC grantees by country
Sources: FDA Import Refusal Report · FDA import alerts by country · openFDA enforcement API