Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 11/13/2025 | AbbVie Inc. North Chicago | UNITED STA | ONABOTULINUMTOXINA | |
| 11/13/2025 | Cipca Ltd Goa | INDIA | ALBUTEROL (BRONCHODILATOR) | |
| 11/13/2025 | OMEGA BIOTECH LTD Roorkee | INDIA | ERYTHROMYCIN (MACROLIDES) | |
| 11/13/2025 | Alkem Laboratories Pvt Ltd Hyderabad | INDIA | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | |
| 11/13/2025 | ALEMBIC Mumbai | INDIA | ERYTHROMYCIN (MACROLIDES) | |
| 11/13/2025 | Cipla Haridwar | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | |
| 11/13/2025 | Pfizer Manufacturing Deutschland GmbH Freiburg Im Breisgau | GERMANY | MISCELLANEOUS PATENT MEDICINES, ETC. | |
| 11/13/2025 | Astonea Labs Private Limited Distt. Panchkula | INDIA | LIDOCAINE (ANESTHETIC) | |
| 11/13/2025 | Astonea Labs Private Limited Distt. Panchkula | INDIA | BACITRACIN ZINC (PEPTIDES) | |
| 11/13/2025 | ALTRUAN GMBH Massing | GERMANY | NEEDLE, HYPODERMIC, SINGLE LUMEN | |
| 11/13/2025 | DHNP Gyeonggi-Do | SOUTH KORE | OTHER COSMETIC RAW MATERIALS, N.E.C. | |
| 11/13/2025 | GUANGZHOU PLUSLIFE BIOTECH CO. LTD. Guangzhou | CHINA | COVID-19 MULTI-ANALYTE RESPIRATORY PANEL NUCLEIC ACID DEVICES | |
| 11/13/2025 | Allergan Industrie SAS Pringy | FRANCE | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | |
| 11/13/2025 | IBSA Farmaceutici Italia Srl Lodi | ITALY | ACID, HYALURONIC, INTRAARTICULAR | |
| 11/13/2025 | SBL Private Limited East Delhi | INDIA | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | |
| 11/13/2025 | SBL Private Limited East Delhi | INDIA | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | |
| 11/13/2025 | Vichy Lab Paris 8e Arrondissement | FRANCE | ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 118NOT LISTED |
| 11/13/2025 | VICHY Vichy | FRANCE | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED |
| 11/13/2025 | Eucerin Hamburg | GERMANY | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED |
| 11/13/2025 | I.F. CANTABRIA Santander | SPAIN | ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED |
| 11/13/2025 | E11EMENT INC. Scarborough | CANADA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 11/13/2025 | Dabur India Solan | INDIA | HERBALS & BOTANICAL TEAS, N.E.C. | 75UNAPPROVED |
| 11/13/2025 | Dabur India Solan | INDIA | HERBALS & BOTANICAL TEAS, N.E.C. | 75UNAPPROVED |
| 11/13/2025 | CIPLA LTD Sikkim | INDIA | SODIUM CHLORIDE (REPLENISHER) | 75UNAPPROVED |
| 11/13/2025 | AMRUTANJAN HEALTH CARE Mylapore | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 11/13/2025 | CORAT LABORATORIES Dehradun | INDIA | BENZOCAINE (ANESTHETIC) | 75UNAPPROVED |
| 11/13/2025 | WEXCARE PHARMACEUTICAL PVT LTD Mehsana | INDIA | CHLORHEXIDINE GLUCONATE | 75UNAPPROVED |
| 11/13/2025 | WEXCARE PHARMACEUTICAL PVT LTD Mehsana | INDIA | CHLORZOXAZONE (RELAXANT) | 75UNAPPROVED |
| 11/13/2025 | Microlabs Ltd Sikkim | INDIA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 11/13/2025 | CORONA REMEDIES PVT. LTD Tehsil Solan | INDIA | ERGOTAMINE TARTRATE (ANALGESIC) | 75UNAPPROVED |
| 11/13/2025 | Eris Lifesciences Kamrup | INDIA | TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 11/13/2025 | Zydus Healthcare Rangpo Sikkim | INDIA | IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED |
| 11/13/2025 | Zydus Healthcare Rangpo Sikkim | INDIA | IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED |
| 11/13/2025 | UNISON PHARMACEUTICALS PVT LTD SANAND | INDIA | ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED |
| 11/13/2025 | Apex Laboratories Private Ltd Alathur | INDIA | ZINC (MINERAL) | 75UNAPPROVED |
| 11/13/2025 | Eris Lifesciences Kamrup | INDIA | TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 11/13/2025 | GLENMARK PHARMACEUTICAL Baddi | INDIA | TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 11/13/2025 | PURE&PURE HEALTH CARE PVT LTD Sidcul Ranipure | INDIA | ROSUVASTATIN CALCIUM | 75UNAPPROVED |
| 11/13/2025 | IPCA LABORATORIES LIMITED BHARIKHOLA | INDIA | DUTASTERIDE | 75UNAPPROVED |
| 11/13/2025 | IPCA LABORATORIES LTD Mumbai | INDIA | MIRABEGRON (ADRENERGIC) | 75UNAPPROVED |
| 11/13/2025 | CIPLA LIMITED Mumbai | INDIA | METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED |
| 11/13/2025 | CIPLA LIMITED Mumbai | INDIA | TORSEMIDE (DIURETIC) | 75UNAPPROVED |
| 11/13/2025 | Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd) Daman | INDIA | TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 11/13/2025 | SANOFI HEALTHCARE INDIA PVT LTD Verna | INDIA | RAMIPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 11/13/2025 | RPG LIFE SCIENCE LTD Ankleshwar | INDIA | SPIRONOLACTONE (DIURETIC) | 75UNAPPROVED |
| 11/13/2025 | JM LIFESCIENCES PRIVATE LIMITED Mumbai | INDIA | CYSTEINE HYDROCHLORIDE (NUTRIENT/TONIC) | 75UNAPPROVED |
| 11/13/2025 | Laborate Pharmaceu Panipat | INDIA | DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED |
| 11/13/2025 | NEON LABS Mumbai | INDIA | LIDOCAINE HCL (ANESTHETIC) | 75UNAPPROVED |
| 11/13/2025 | NOVO NORDISK Mississauga | CANADA | SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 11/13/2025 | Delpharm Milano Srl Segrate | ITALY | CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
About This Page
This page displays 50 FDA import refusal records from 9 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 75 (UNAPPROVED), 3260 (NO ENGLISH), 237 (NO PMA) and 1 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 126 of 10,077 • Showing records 6,251-6,300 of 503,850 total