Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 9/23/2025 | PROFESSIONAL DERMA Lugano | SWITZERLAN | FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED |
| 9/23/2025 | ALLERGAN Koeln | GERMANY | LIDOCAINE | 118NOT LISTED |
| 9/23/2025 | Cosmecca Korea Co., Ltd. Eumseong | SOUTH KORE | MOISTURIZING (SKIN CARE PREPARATIONS) | 118NOT LISTED |
| 9/23/2025 | PASTURE PHARMA PTE LTD Singapore | SINGAPORE | RIVAROXABAN | 75UNAPPROVED |
| 9/23/2025 | BC LTD C/O PASTURE Singapore | SINGAPORE | APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED |
| 9/23/2025 | BC LTD C/O PASTURE Singapore | SINGAPORE | APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED |
| 9/23/2025 | BC LTD C/O PASTURE Singapore | SINGAPORE | APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED |
| 9/23/2025 | BC LTD C/O PASTURE Singapore | SINGAPORE | APIXABAN (ANTI-COAGULANT) | 75UNAPPROVED |
| 9/23/2025 | Pfizer Manufacturing Belgium NV Puurs-Sint-Amands | BELGIUM | WATER, PURIFIED (EYEWASH) | 75UNAPPROVED |
| 9/23/2025 | IMPERIAL FEET B.V. Dronten | NETHERLAND | OTHER MANICURING PREPARATIONS, N.E.C. | 75UNAPPROVED |
| 9/23/2025 | Novo Nordisk A/S Bagsvard | DENMARK | SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 9/23/2025 | PROCTER Y GAMBLE LABORATORY Guatemala | GUATEMALA | SODIUM (MINERAL) | 75UNAPPROVED |
| 9/23/2025 | MEDPHARMA Guatemala | GUATEMALA | VITAMIN C (ASCORBIC ACID) | 75UNAPPROVED |
| 9/23/2025 | LATIN FARMA SA Amatitlan | GUATEMALA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED |
| 9/23/2025 | DROGUERIA Y LABORATORIOS ROLAND Guatemala | GUATEMALA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED |
| 9/23/2025 | DONOVAN WERKE San Juan | GUATEMALA | VITAMIN D2 (CALCIFEROL) | 75UNAPPROVED |
| 9/23/2025 | BDF CENTROAMERICANA SA Guatemala City | GUATEMALA | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED |
| 9/23/2025 | Alfredo Herbruger Jr Company Ltda Guatemala Ca | GUATEMALA | DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 9/23/2025 | WHANIN PHARMACEUTICAL Seoul | SOUTH KORE | HOMEOPATHIC GASTROINTESTINAL | 75UNAPPROVED |
| 9/23/2025 | KUHNIL PHARM CO Republic Of Korea | SOUTH KORE | PANCREATIN (ENZYME) | 75UNAPPROVED |
| 9/23/2025 | KOREA UNITED PHARM Sejong | SOUTH KORE | MAGNESIUM HYDROXIDE (ANTACID) | 75UNAPPROVED |
| 9/23/2025 | BUKWANG PHARM CO Ansan Si | SOUTH KORE | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED |
| 9/23/2025 | Daewoong Pharmaceutical, Co., Ltd. Seoul | SOUTH KORE | ANTI-DIURETIC N.E.C. | 75UNAPPROVED |
| 9/23/2025 | ALVOGEN KOREA Seoul | SOUTH KORE | RIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC) | 75UNAPPROVED |
| 9/23/2025 | DIPROFA Q Texcoco | MEXICO | SUCRALFATE (ANTACID) | 75UNAPPROVED |
| 9/23/2025 | MEDERI LAB SAPI DE CV Jalisco | MEXICO | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 9/23/2025 | MEDERI LAB SAPI DE CV Jalisco | MEXICO | CHLORHEXIDINE GLUCONATE | 75UNAPPROVED |
| 9/23/2025 | VEDILAB S.A. DE C.V. Queretaro | MEXICO | FUROSEMIDE (DIURETIC) | 75UNAPPROVED |
| 9/23/2025 | LANORATORIOS KIRON MEXICO SA DE Nezahualcoyotl | MEXICO | CARDIOTONIC N.E.C. | 75UNAPPROVED |
| 9/23/2025 | SERVIER LABORATORY MEXICO SA DE Mexico City | MEXICO | PERINDOPRIL ERBUMINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 9/23/2025 | ALFASIGMA LABORATORIES MEXICO SA Alvaro | MEXICO | ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED |
| 9/23/2025 | ULTRA LABORATORIOS Guadalajara | MEXICO | ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED |
| 9/23/2025 | Antibioticos de Mexico S.A. de C.V. Ciudad De Mexico | MEXICO | MEMANTINE HCI | 75UNAPPROVED |
| 9/23/2025 | UCB PHARMA COMPANY Mexico City | MEXICO | TITANIUM DIOXIDE (PROTECTANT) | 75UNAPPROVED |
| 9/23/2025 | ANCALMO LABORATORIES El Salvador | EL SALVADO | FURAZOLIDONE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED |
| 9/23/2025 | Laboratorios Ramos, S.A. Managua | NICARAGUA | PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED |
| 9/23/2025 | Laboratorios Ramos, S.A. Managua | NICARAGUA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 9/23/2025 | LABORATORIES UNIMARK Oeste | NICARAGUA | GABAPENTIN (ANTI-DEPRESSANT) | 75UNAPPROVED |
| 9/23/2025 | LABORATORIOS CEGUEL SA Managua | NICARAGUA | ALOE (HERBAL AND BOTANICAL (NOT TEAS) II (CONTINUED)) | 75UNAPPROVED |
| 9/23/2025 | P & G De Mexico (Vallejo) Mexico City | MEXICO | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 9/23/2025 | CAPLIN POINT LABORATORIES LTD Chennai | INDIA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 9/23/2025 | CAPLIN POINT LABORATORIES LTD Chennai | INDIA | LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED |
| 9/23/2025 | CAPLIN POINT LABORATORIES LTD Chennai | INDIA | IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 9/23/2025 | BALAXI PHARMACEUTICALS LIMITED Telangana | INDIA | METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED |
| 9/23/2025 | AGIO PHARMACEUTICALS LTD Bhosari | INDIA | DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 9/23/2025 | HELIX SWEDEN AB Helsingborg | SWEDEN | NICOTINE POUCH | |
| 9/23/2025 | Swedish Match Ab Stockholm | SWEDEN | NICOTINE POUCH | |
| 9/23/2025 | UNIVERDERM Paris | FRANCE | IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 39053905 |
| 9/23/2025 | UNION MEDICO APS Copenhagen | DENMARK | INTRODUCER, SYRINGE NEEDLE | |
| 9/23/2025 | HealingFarm Agriculture Company Co.,Ltd. Geochang | SOUTH KORE | HERBALS & BOTANICALS (NOT TEAS), N.E.C. |
About This Page
This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 118 (NOT LISTED), 75 (UNAPPROVED), 3842 (TP NO PMTA), 3843 (TP NO SE), 3854 (TPLKUSSLLB) and 4 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.
Viewing page 256 of 10,077 • Showing records 12,751-12,800 of 503,850 total