Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 9/23/2025 | Morepen Laboratories Limited Solan | INDIA | THEOPHYLLINE (BRONCHODILATOR) | 75UNAPPROVED |
| 9/23/2025 | Ind Swift Ltd Samba | INDIA | MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED |
| 9/23/2025 | ACME Formulation Private Limited Solan | INDIA | OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED |
| 9/23/2025 | Shree Dhootapapeshwar Ltd Mumbai | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/23/2025 | MS AROGYODAYAM HERBAL PRODUCT Kerala | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/23/2025 | THE ARYA VAIDYA PHARMACY Kerala | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/23/2025 | THE ARYA VAIDYA PHARMACY Kerala | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/23/2025 | AASHIRWAD AYURVEDA PHARMACY Coimbatore | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/23/2025 | AVN Ayurveda Formulations Private Limited Madurai | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/23/2025 | Gufic Biosciences Limited Belgaum | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/23/2025 | Gufic Biosciences Limited Belgaum | INDIA | BOSWELLIA (HERBAL & BOTANICAL TEAS) | 75UNAPPROVED |
| 9/23/2025 | THE ARYA VAIDYA PHARMACY (COIMBA Kerala Pin | MALAYSIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 9/23/2025 | AASHIRWAD AYURVEDA PHARMACY Coimbatore | INDIA | TRIBULUS (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED |
| 9/23/2025 | Incepta Pharmaceuticals Ltd Dhaka | BANGLADESH | LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 9/23/2025 | BEXIMCO PHARMACEUTICALS LIMITED Dhaka | BANGLADESH | ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED |
| 9/23/2025 | Novartis (Bangladesh Limited Gazipur | BANGLADESH | METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 9/23/2025 | Incepta Pharmaceuticals Ltd Dhaka | BANGLADESH | ESCITALOPRAM OXALATE | 75UNAPPROVED |
| 9/23/2025 | SUN PHARMACEUTICALS LTD Dhaka | BANGLADESH | MIRTAZAPINE (ANTI-DEPRESSANT) | 75UNAPPROVED |
| 9/23/2025 | ACI LIMITED Tejgaon Industrial Ar | BANGLADESH | PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED |
| 9/23/2025 | BOHERINGER INGELHEIM Mexico City | MEXICO | EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 9/23/2025 | Laboratorios Liomont, S.A. de C.V. Ciudad De Mexico | MEXICO | PIOGLITAZONE HCL | 75UNAPPROVED |
| 9/23/2025 | Laboratorios Farmaceuticos Rovi S.A. Alcala De Henares | SPAIN | ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED |
| 9/23/2025 | Merck, S.A. de C.V. Naucalpan De Juarez | MEXICO | LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED |
| 9/23/2025 | Laboratoires Mayoly- Spindler Chatou | FRANCE | BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED |
| 9/23/2025 | IPR Pharmaceuticals, Inc. Canovanas | UNITED STA | ROSUVASTATIN CALCIUM | 75UNAPPROVED |
| 9/23/2025 | ABOTT INDIA LIMITED Puducherry | INDIA | DYDROGESTERONE (PROGESTIN) | 75UNAPPROVED |
| 9/23/2025 | MEDPHARMA Guatemala | GUATEMALA | VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED |
| 9/23/2025 | Industria Farmaceutica, S.A. Mixco | GUATEMALA | CAMPHOR (ANTI-PRURITIC) | 75UNAPPROVED |
| 9/23/2025 | GENOMA LAB GUATEMALA Guatemala | GUATEMALA | VITAMIN B6 (PYRIDOXINE) | 75UNAPPROVED |
| 9/23/2025 | DROGUERIA Y LABORATORIOS ROLAND Guatemala | GUATEMALA | VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED |
| 9/23/2025 | KARMA AYURVEDA Delhi | INDIA | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 75UNAPPROVED |
| 9/23/2025 | Mesosystems Sa Porto | PORTUGAL | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED |
| 9/23/2025 | Quinfica Nutramedics Boldo Guatemala | GUATEMALA | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED |
| 9/23/2025 | LANKETIN Guatemala City | GUATEMALA | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED |
| 9/23/2025 | DAVIS S.A. Zona | GUATEMALA | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED |
| 9/23/2025 | Quinfica Nutramedics Boldo Guatemala | GUATEMALA | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED |
| 9/23/2025 | BAYER Bogota | COLOMBIA | DEVICE, INTRAUTERINE, CONTRACEPTIVE AND INTRODUCER | 75UNAPPROVED |
| 9/23/2025 | CRUZ VERDE Cdad | GUATEMALA | TETRACYCLINE (TETRACYCLINES) | 75UNAPPROVED |
| 9/23/2025 | UNIDOS GT San Lucas Toliman | GUATEMALA | DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED |
| 9/23/2025 | CRUZ VERDE Cdad | GUATEMALA | DIIODOHYDROXYQUIN (ANTI-AMEBIC) | 75UNAPPROVED |
| 9/23/2025 | UNIDOS GT San Lucas Toliman | GUATEMALA | CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED |
| 9/23/2025 | FARMAZA Cdad | GUATEMALA | FOSFOMYCIN TROMETHAMINE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 9/23/2025 | UNIDOS GT San Lucas Toliman | GUATEMALA | REPLENISHER N.E.C. | 75UNAPPROVED |
| 9/23/2025 | UNIDOS GT San Lucas Toliman | GUATEMALA | REPLENISHER N.E.C. | 75UNAPPROVED |
| 9/23/2025 | Sami-Sabinsa Group Limited MEDCHAL-MALKAJGIRI DT | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 9/23/2025 | CARL ZEISS MICROSCOPY GMBH Stadtroda | GERMANY | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD |
| 9/23/2025 | Rits Lifesciences Private Limited Olpad | INDIA | GINSENG (HERBAL & BOTANICALS, NOT TEAS) | |
| 9/23/2025 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. Ambernath (E) | INDIA | COCONUT, SHELLED | 9SALMONELLA |
| 9/23/2025 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. Ambernath (E) | INDIA | COCONUT, SHELLED | 9SALMONELLA |
| 9/23/2025 | Bessan Makarna Gida San. Ve Tic. A.S. Sehitkamil | TURKEY | SEMOLINA, WHEAT | 9SALMONELLA |
About This Page
This page displays 50 FDA import refusal records from 12 countries. Records on this page involve violations including 75 (UNAPPROVED), 47 (NON STD), 11 (UNSAFE COL), 9 (SALMONELLA). Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 253 of 10,077 • Showing records 12,601-12,650 of 503,850 total