Import Refusal Records
501,854 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 12/5/2025 | THERMAEX FARMACEUTICAL Sao Paulo | BRAZIL | ESTRADIOL (ESTROGEN) | 75UNAPPROVED |
| 12/5/2025 | BIOLAB SANUS Sao Paulo | BRAZIL | ESTROGEN N.E.C. | 75UNAPPROVED |
| 12/5/2025 | Farmoquimica S.A. Rio De Janeiro | BRAZIL | PROGESTERONE (PROGESTIN) | 75UNAPPROVED |
| 12/5/2025 | EMS PHARMA Hortolandia | BRAZIL | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/5/2025 | ELABORADO POR LA FABRIFARMA SA Bogota | COLOMBIA | VALPROIC ACID (ANTI-CONVULSANT) | 75UNAPPROVED |
| 12/5/2025 | Swati Spentose Private Limited Vapi | INDIA | PENTOSAN POLYSULFATE SODIUM (URICOSURIC) | 75UNAPPROVED |
| 12/5/2025 | CALOX LABORATORIES SA Tenango | GUATEMALA | KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/5/2025 | RAMOS LABORATORIES SA Managua | NICARAGUA | AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED |
| 12/5/2025 | RAMOS LABORATORIES SA Managua | NICARAGUA | DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED |
| 12/5/2025 | ASPEN LABORATORIES Tecla | GUATEMALA | MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED |
| 12/5/2025 | NICATE LABORATORIES Managua | NICARAGUA | ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED |
| 12/5/2025 | LARRY LABORATORIES SA Santa Fe | EL SALVADO | MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED |
| 12/5/2025 | Colgate Palmolive Centro America Sa Guatemala | GUATEMALA | ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED |
| 12/5/2025 | NATURAL MEDICALS LABORATORIES SA Managua | NICARAGUA | ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED |
| 12/5/2025 | MARLEN LEMUR LABORATORIES SA San Jose | COSTA RICA | NICOTINAMIDE (NIACINAMIDE) (VITAMIN) | 75UNAPPROVED |
| 12/5/2025 | PHARMA INTERNAYTIONAL LABORATORI Salvador | EL SALVADO | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/5/2025 | MERCK-MEXICO SA Mexico Df | MEXICO | VITAMIN B1 (THIAMINE) | 75UNAPPROVED |
| 12/5/2025 | BIOMEDIKAL LABORATORIES S Salvador | EL SALVADO | VITAMIN B1 (THIAMINE) | 75UNAPPROVED |
| 12/5/2025 | PRO LABS Guatemala City | GUATEMALA | CALCIUM (MINERAL) | 75UNAPPROVED |
| 12/5/2025 | ANPHAR LABORATORIES SA MEDICAL C Tegucigalpa | HONDURAS | AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/5/2025 | CAPLIN POINT LABORATORIES OF GUA Guatemala City | GUATEMALA | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/5/2025 | LANCASCO LABORATORIES SA Mixco | GUATEMALA | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/5/2025 | CAPLIN POINT LABORATORIES OF GUA Guatemala City | GUATEMALA | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 12/5/2025 | Alkem Laboratories Ltd Mumbai | INDIA | VIT D | 75UNAPPROVED |
| 12/5/2025 | VANGUARD THERAPUETICS PVT LTD Hyderabad | INDIA | LOPERAMIDE (ANTI-PERISTALTIC) | 75UNAPPROVED |
| 12/5/2025 | Micro Labs Ltd Bangalore | INDIA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 12/5/2025 | ADINEX HEALTHCARE New Delhi | INDIA | DOMPERIDONE | 75UNAPPROVED |
| 12/5/2025 | ABBOTT INDIA Mumbai | INDIA | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 12/5/2025 | Blue Cross Lab Ltd Mumbai | INDIA | DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED |
| 12/5/2025 | THE HIMALAYA DRUG COMPANY Tehsil Paonta Sahib | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/5/2025 | THE HIMALAYA DRUG COMPANY Tehsil Paonta Sahib | INDIA | AMLA (HERBAL & BOTANICALS, NOT TEAS II) | 75UNAPPROVED |
| 12/5/2025 | THE HIMALAYA DRUG COMPANY Tehsil Paonta Sahib | INDIA | HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED |
| 12/5/2025 | OPTHO LIFE SCIENCES PVT LTD Noida | INDIA | CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 75UNAPPROVED |
| 12/5/2025 | AJANTA PHARMA LTD MUMBAI | INDIA | GATIFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 12/5/2025 | ENTOD PHARM Mumbai | INDIA | EMOLLIENT, LUBRICANT, N.E.C. | 75UNAPPROVED |
| 12/5/2025 | AVYUKT PHARMACEUTICALS Karnataka | INDIA | BETAHISTINE HCL (VASODILATOR) | 75UNAPPROVED |
| 12/5/2025 | RABNEW PHARMA Panchkula | INDIA | LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED |
| 12/5/2025 | CIPLA LTD Mumbai | INDIA | EMPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/5/2025 | Apex Laboratories Private Ltd Alathur | INDIA | VITAMIN B2 (RIBOFLAVIN) | 75UNAPPROVED |
| 12/5/2025 | Icpa Health Products Ltd Ankleshwar | INDIA | ACONITE (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED |
| 12/5/2025 | Procter & Gamble India Ltd Mumbai | INDIA | VITAMIN B1 (THIAMINE) | 75UNAPPROVED |
| 12/5/2025 | FABRICADO POR PHARMA Guatamala | UNITED STA | PREDNISOLONE TEBUTATE (GLUCOCORTICOID) | 75UNAPPROVED |
| 12/5/2025 | JB PHARMA Nagpur | INDIA | TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/5/2025 | CIPLA PHARMA AND LIFE SCIENCE LT Mumbai | INDIA | METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/5/2025 | ESSENCIAL FARMUS Goiania | BRAZIL | TESTOSTERONE (ANDROGEN) | 75UNAPPROVED |
| 12/5/2025 | Sanofi Canada Laval | CANADA | INSULIN (INJ) (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/5/2025 | AstraZeneca Canada Inc. Mississauga | CANADA | DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/5/2025 | ELI LILLY CANADA INC Toronto | CANADA | TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 12/5/2025 | PHARMACY DOT CLOUD Winnipeg | CANADA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 12/5/2025 | Dr Reckeweg New Delhi | INDIA | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
About This Page
This page displays 50 FDA import refusal records from 11 countries. Records on this page involve violations including 75 (UNAPPROVED). Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 35 of 10,038 • Showing records 1,701-1,750 of 501,854 total