Import Refusal Records
501,854 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 11/25/2025 | HETERO Bogota | COLOMBIA | QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED |
| 11/25/2025 | Organon Pharma (UK) Ltd. Cramlington | UNITED KIN | SITAGLIPTIN PHOSPHATE (ANTI-DIABETIC) | 75UNAPPROVED |
| 11/25/2025 | Boehringer Ingelheim S.A. Bogota | COLOMBIA | EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 11/25/2025 | Legrand Sa Bogota | COLOMBIA | ROSUVASTATIN CALCIUM | 75UNAPPROVED |
| 11/25/2025 | Merck Colombia Sa Bogota | COLOMBIA | LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED |
| 11/25/2025 | Selectepharma Mixco | GUATEMALA | CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 11/25/2025 | Laboratorios Farkot, S.A. Guatemala City | GUATEMALA | VITAMIN D2 (CALCIFEROL) | 75UNAPPROVED |
| 11/25/2025 | DRODIFARMA LAB Guatemala City | GUATEMALA | VITAMIN B1 (THIAMINE) | 75UNAPPROVED |
| 11/25/2025 | DRODIFARMA LAB Guatemala City | GUATEMALA | NIACIN (NICOTINIC ACID) (VITAMIN) | 75UNAPPROVED |
| 11/25/2025 | Laboratorios Farkot, S.A. Guatemala City | GUATEMALA | VITAMIN K (PHYTONADIONE) | 75UNAPPROVED |
| 11/25/2025 | Verionica Lucia Vasquez Lopez Ambato | ECUADOR | SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | |
| 11/25/2025 | Verionica Lucia Vasquez Lopez Ambato | ECUADOR | SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.) | |
| 11/25/2025 | Sun Pharmaceutical Industries Ltd. Halol | INDIA | TOBRAMYCIN (ANTI-MICROBIAL) | |
| 11/25/2025 | Sun Pharmaceutical Industries Ltd. Halol | INDIA | CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Shandong Binzhou Jonnic Food Co., Ltd Binzhou | CHINA | HAW, DRIED OR PASTE | |
| 11/25/2025 | Mado Pasticcerie Bari | ITALY | PISTACHIO, SPREAD | 11UNSAFE COL |
| 11/25/2025 | Mado Pasticcerie Bari | ITALY | PISTACHIO, SPREAD | 11UNSAFE COL |
| 11/25/2025 | Mado Pasticcerie Bari | ITALY | PISTACHIO, SPREAD | 11UNSAFE COL |
| 11/25/2025 | Mado Pasticcerie Bari | ITALY | PISTACHIO, SPREAD | 11UNSAFE COL |
| 11/25/2025 | GALLANT OCEAN INTERNATIONAL, INC. XIAOGANG PLANT KAOHSIUNG | TAIWAN | BARRAMUNDI | 9SALMONELLA |
| 11/25/2025 | Tongwei Hainan Aquatic Products Co., Ltd. Chengmai County | CHINA | TILAPIA, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS | 9SALMONELLA |
| 11/25/2025 | Saidowla (Pvt.)Enterprise Limited Choukide Khi | BANGLADESH | FISH, N.E.C. | 9SALMONELLA |
| 11/25/2025 | Saidowla (Pvt.)Enterprise Limited Choukide Khi | BANGLADESH | FISH, N.E.C. | 9SALMONELLA |
| 11/25/2025 | NGP TOBACCO Aalborg Sv | DENMARK | NICOTINE DELIVERY PRODUCT, NEC | 3854TPLKUSSLLB |
| 11/25/2025 | XQS INTERNATIONAL AB Borlange | SWEDEN | NICOTINE POUCH | 3854TPLKUSSLLB |
| 11/25/2025 | XQS INTERNATIONAL AB Borlange | SWEDEN | NICOTINE POUCH | 3854TPLKUSSLLB |
| 11/25/2025 | XQS INTERNATIONAL AB Borlange | SWEDEN | NICOTINE POUCH | 3854TPLKUSSLLB |
| 11/25/2025 | Swedish Match Ab Stockholm | DENMARK | NICOTINE POUCH | 3854TPLKUSSLLB |
| 11/25/2025 | Swedish Match Ab Stockholm | DENMARK | NICOTINE POUCH | 3854TPLKUSSLLB |
| 11/25/2025 | Swedish Match Ab Stockholm | DENMARK | NICOTINE POUCH | 3854TPLKUSSLLB |
| 11/25/2025 | Swedish Match Ab Stockholm | DENMARK | NICOTINE POUCH | 3854TPLKUSSLLB |
| 11/25/2025 | XQS INTERNATIONAL AB Borlange | SWEDEN | NICOTINE POUCH | 3854TPLKUSSLLB |
| 11/25/2025 | XQS INTERNATIONAL AB Borlange | SWEDEN | NICOTINE POUCH | 3854TPLKUSSLLB |
| 11/25/2025 | XQS INTERNATIONAL AB Borlange | SWEDEN | NICOTINE POUCH | 3854TPLKUSSLLB |
| 11/25/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE POUCH | |
| 11/25/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE POUCH | |
| 11/25/2025 | NGP TOBACCO APS Norager | DENMARK | NICOTINE POUCH | |
| 11/25/2025 | NGP TOBACCO APS Norager | DENMARK | NICOTINE POUCH | |
| 11/25/2025 | NGP TOBACCO APS Norager | DENMARK | NICOTINE POUCH |
About This Page
This page displays 50 FDA import refusal records from 11 countries. Records on this page involve violations including 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 27 (DRUG GMPS), 11 (UNSAFE COL) and 4 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 56 of 10,038 • Showing records 2,751-2,800 of 501,854 total