Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 1/2/2026 | Sun Pharma Laboratories Ld East-Sikkim | INDIA | ROSUVASTATIN CALCIUM | 75UNAPPROVED |
| 1/2/2026 | RAVENBHEI BIOTECH Jammu | INDIA | ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED |
| 1/2/2026 | MANKIND INDIA LTD Delhi | INDIA | AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED |
| 1/2/2026 | Exemed Pharmaceuticals Vapi | INDIA | SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED |
| 1/2/2026 | Intas Pharmaceuticals Limited Gangtok | INDIA | LAMOTRIGINE (ANTI-CONVULSANT) | 75UNAPPROVED |
| 1/2/2026 | Besins Manufacturing Belgium Drogenbos | BELGIUM | PROGESTERONE (PROGESTIN) | 75UNAPPROVED |
| 1/2/2026 | Besins Manufacturing Belgium Drogenbos | BELGIUM | ESTRADIOL (ESTROGEN) | 75UNAPPROVED |
| 1/2/2026 | VINCENTE SCAVONE & CIA SAE San Lorenzo | PARAGUAY | ZOLPIDEM TARTRATE (SEDATIVE) | 75UNAPPROVED |
| 1/2/2026 | SAVAL LAB Santiago | CHILE | BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED |
| 1/2/2026 | COLLINS S.A. GUADALAJARA | MEXICO | CEFTRIAXONE SODIUM (CEPHALOSPORINS) | 75UNAPPROVED |
| 1/2/2026 | COLLINS S.A. GUADALAJARA | MEXICO | DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED |
| 1/2/2026 | Dr. Reddy's Laboratories Hyderabad | INDIA | ROSUVASTATIN CALCIUM | 75UNAPPROVED |
| 1/2/2026 | Dr. Reddy's Laboratories Hyderabad | INDIA | GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 1/2/2026 | Sun Pharmaceutical Industries Mumbai | INDIA | ANTI-DIABETIC N.E.C. | 75UNAPPROVED |
| 1/2/2026 | Sun Pharmaceutical Industries Mumbai | INDIA | OLMESARTAN MEDOXOMIL | 75UNAPPROVED |
| 1/2/2026 | USV Private Limited Vadodara | INDIA | METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED |
| 1/2/2026 | KURUMBALA HERBAL AND RESEARCH Tamilnadu | INDIA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED |
| 1/2/2026 | KURUMBALA HERBAL AND RESEARCH Tamilnadu | INDIA | LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED |
| 1/2/2026 | KURUMBALA HERBAL AND RESEARCH Tamilnadu | INDIA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED |
| 1/2/2026 | KURUMBALA HERBAL AND RESEARCH Tamilnadu | INDIA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED |
| 1/2/2026 | KURUMBALA HERBAL AND RESEARCH Tamilnadu | INDIA | ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED |
| 1/2/2026 | KURUMBALA HERBAL AND RESEARCH Tamilnadu | INDIA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED |
| 1/2/2026 | KURUMBALA HERBAL AND RESEARCH Tamilnadu | INDIA | METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 1/2/2026 | Cipla Limited Mumbai | INDIA | TORSEMIDE (DIURETIC) | 75UNAPPROVED |
| 1/2/2026 | Sun Pharmaceutical Industries Ltd Mumbai | INDIA | ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED |
| 1/2/2026 | ERIS LIFE SCIENCE LTD Ahmedabad | INDIA | CALCIUM (MINERAL) | 75UNAPPROVED |
| 1/2/2026 | BOEHRINGER INGELHEIM INDIA PVT Mumbai | INDIA | LINAGLIPTIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 1/2/2026 | INTAS PHARMACEUTIAL Thaltej | INDIA | CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 1/2/2026 | LABORATORIOS LA SANTE Bogota | COLOMBIA | TADALAFIL | 75UNAPPROVED |
| 1/2/2026 | ANTON GLOBAL PHARMACEUTCALS PVT Mumbai | INDIA | IVERMECTIN AND COMBINATIONS (ANTIPARASITIC) | 75UNAPPROVED |
| 1/2/2026 | DUKSAN PURE CHEMICALS CO., LTD. Ansan | SOUTH KORE | ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED |
| 1/2/2026 | MARCAN PHARMACEUTICALS INC Nepean | CANADA | DOMPERIDONE | 75UNAPPROVED |
| 1/2/2026 | NOVO NORDISK Mississauga | CANADA | SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 1/2/2026 | LABORATORIOS BONIN S.A Nueva | GUATEMALA | PRAZOSIN HCL (ANTI-HYPERTENSIVE) | 75UNAPPROVED |
| 1/2/2026 | NOVO NORDISK Mississauga | CANADA | SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 1/2/2026 | SHREE PHARMA Nagpur | INDIA | TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 1/2/2026 | GLAXOSMITHKLINE Mississauga | CANADA | FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED |
| 1/2/2026 | GLAXOSMITHKLINE Mississauga | CANADA | IPRATROPIUM BROMIDE (BRONCHODILATOR) | 75UNAPPROVED |
| 1/2/2026 | ASIA HERBS Punjab | INDIA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED |
| 1/2/2026 | AJANTA PHARMA LTD Mumbai | INDIA | NETARSUDIL DIMESYLATE (ENZYME INHIBITOR) | 75UNAPPROVED |
| 1/2/2026 | Emami Limited Pantnagar | INDIA | MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED |
| 1/2/2026 | Laborate Pharmaceuticals India Ltd. Paonta Sahib | INDIA | GENTAMICIN (AMINOGLYCOSIDES) | 75UNAPPROVED |
| 1/2/2026 | METOCRAFT Baddi Solan | INDIA | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 1/2/2026 | V ARUN MEDIPEX Sirmour | INDIA | BENZALDEHYDE (PHARMACEUTIC NECESSITY - FLAVOR) | 75UNAPPROVED |
| 1/2/2026 | Ipca Laboratories Ltd Sikkim | INDIA | DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED |
| 1/2/2026 | Microlabs Ltd Sikkim | INDIA | LOPERAMIDE (ANTI-PERISTALTIC) | 75UNAPPROVED |
| 1/2/2026 | IPCA LABORATORIES LIMITED BHARIKHOLA | INDIA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 1/2/2026 | Pfizer Ltd Bangalore | INDIA | PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED |
| 1/2/2026 | Rivpra Formulation Pvt Ltd Haridwar | INDIA | CHLORPHENIRAMINE POLISTIREX (ANTI-HISTAMINIC) | 75UNAPPROVED |
| 1/2/2026 | Microlabs Ltd Sikkim | INDIA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
About This Page
This page displays 50 FDA import refusal records from 9 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 39 of 10,077 • Showing records 1,901-1,950 of 503,850 total