Import Refusal Records
501,854 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 12/18/2025 | Roche Diagnostics GmbH Mannheim | GERMANY | INVESTIGATIONAL USE ONLY - IMMUNOLOGY | |
| 12/18/2025 | AstraZeneca AB Sodertalje | SWEDEN | DAPAGLIFLOZIN (ANTI-DIABETIC) | |
| 12/18/2025 | DN TANKS LLC Halifax | CANADA | KIT, FIRST AID, TALKING | |
| 12/18/2025 | DN TANKS LLC Halifax | CANADA | KIT, FIRST AID, TALKING | |
| 12/18/2025 | WellsPharmtech Co., Ltd Geumcheon | SOUTH KORE | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | |
| 12/18/2025 | STOCKX ASIA LIMITED Tsuen Wan | HONG KONG | SUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | |
| 12/18/2025 | NEOPHARMA SA DE CV Vallejo | MEXICO | LEVOTHYROXINE SODIUM (THYROID HORMONE) | |
| 12/18/2025 | NEOPHARMA SA DE CV Vallejo | MEXICO | TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | |
| 12/18/2025 | NEOPHARMA SA DE CV Vallejo | MEXICO | HYDROCHLOROTHIAZIDE (DIURETIC) | |
| 12/18/2025 | AVITUS Gustavo A Madero | MEXICO | LORATADINE (ANTI-ASTHMATIC) | |
| 12/18/2025 | ECO MEDI GLOVE SDN BHD Taiping | MALAYSIA | GLOVE, PATIENT EXAMINATION, POLY | 118NOT LISTED |
| 12/18/2025 | Himalaya Wellness Company Nelamangala Taluk | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/18/2025 | HIMALAYA WELLNESS COMPANY Kiadb | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/18/2025 | HIMALAYA WELLNESS COMPANY Kiadb | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/18/2025 | J. C. Udeozor & Sons Global Industries Benin City | NIGERIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 12/18/2025 | IBN HERBALS Baddi | INDIA | PROTEIN N.E.C. | 75UNAPPROVED |
| 12/18/2025 | MICROLABS PVT LTD Namthangroad | INDIA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 12/18/2025 | DR REDDY LABORATORIE API Jinnaram | INDIA | ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED |
| 12/18/2025 | SANOFI CONSUMER HEALTHCARE INDIA Mumbai | INDIA | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/18/2025 | ABBOTT INDIA LTD GOA | INDIA | LACTULOSE (CATHARTIC) | 75UNAPPROVED |
| 12/18/2025 | CILPA LTD Mumbai | INDIA | IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/18/2025 | CADILA HEALTHCARE LTD Goa | INDIA | AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED |
| 12/18/2025 | GlaxoSmith Kline Nashik | INDIA | MUPIROCIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 12/18/2025 | Ipg Life Science Ltd Ankleshwar | INDIA | NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/18/2025 | PURE AND CURE HEALTH CARE PVT LT Ranipur Haridwar | INDIA | MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED |
| 12/18/2025 | CIPLA LTD Ahmedabad | INDIA | BACITRACIN ZINC (PEPTIDES) | 75UNAPPROVED |
| 12/18/2025 | CIPLA LTD Ahmedabad | INDIA | CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 12/18/2025 | ZYDUS HEALTHCARE LTD East Sikkim | INDIA | PANTOPRAZOLE SODIUM | 75UNAPPROVED |
| 12/18/2025 | Abbvie Corporation Saint-Laurent | CANADA | CALCITONIN (ANTI-HYPERCALCEMIC) | 75UNAPPROVED |
| 12/18/2025 | NOVO NORDISK Latina Scalo | ITALY | TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/18/2025 | PURE AND CURE HEALTHCARE Delhi | INDIA | BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED |
| 12/18/2025 | PURE AND CURE HEALTHCARE Delhi | INDIA | CIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 12/18/2025 | SUN PHARMA LABORATORIES LTD Palasbari | INDIA | AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED |
| 12/18/2025 | EMCARE PHARMACEUTICALS Bari Brahmana | INDIA | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/18/2025 | EMCARE PHARMACEUTICALS Bari Brahmana | INDIA | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/18/2025 | Mankind Pharma Ltd. New Delhi | INDIA | CEFPODOXIME PROXETIL (CEPHALOSPORINS) | 75UNAPPROVED |
| 12/18/2025 | TACTUS NUTRASCIENCES LLP Ahmedabad | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/18/2025 | TORRENT PHARMACEUTICALS LTD Gangtok Sikkim | INDIA | LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 12/18/2025 | Niranta Mumbai | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/18/2025 | AYUCARE PHARMACEUTICALS PVT Ahmedabad | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/18/2025 | AUSHADHI BHAVAN AYURVED Nashik | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/18/2025 | AUSHADHI BHAVAN AYURVED Nashik | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/18/2025 | SHREE MAHANARAYAN Ahmedabad | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/18/2025 | Vyas Pharmaceuticals Indore | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/18/2025 | MEWAD AYURVEDIC WORKS Baliya | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/18/2025 | ABBOTT INDIA BADDI | INDIA | THYROXINE I 125 (RADIOACTIVE AGENT) | 75UNAPPROVED |
| 12/18/2025 | Alkem Health Science Sikkim | INDIA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 12/18/2025 | Alkem Health Science Sikkim | INDIA | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/18/2025 | MEDREICH LIMITED Bengaluru | INDIA | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/18/2025 | AstraZeneca Canada Inc. Mississauga | CANADA | PANTOPRAZOLE SODIUM | 75UNAPPROVED |
About This Page
This page displays 50 FDA import refusal records from 10 countries. Records on this page involve violations including 118 (NOT LISTED), 508 (NO 510(K)), 472 (NO ENGLISH), 341 (REGISTERED), 237 (NO PMA) and 3 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 14 of 10,038 • Showing records 651-700 of 501,854 total