Import Refusal Records
503,850 FDA import refusal records
| Date | Firm | Country | Product | Violations |
|---|---|---|---|---|
| 11/10/2025 | MANKIND PHARMA LTD DORNING Sikkim | INDIA | MECOBALAMIN (VITAMIN) | 75UNAPPROVED |
| 11/10/2025 | Usv Limited Bangalore | INDIA | ASPIRIN (ANALGESIC) | 75UNAPPROVED |
| 11/10/2025 | SBL Private Limited East Delhi | INDIA | ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED |
| 11/10/2025 | INTAS PHARMACEUTICALS LTD Ahmedabad | INDIA | DIVALPROEX SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED |
| 11/10/2025 | EXIZEN LIFESCIENCES LLP Hyderabad | INDIA | ESCITALOPRAM OXALATE | 75UNAPPROVED |
| 11/10/2025 | Square Pharmaceuticals PLC Gazipur | BANGLADESH | ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED |
| 11/10/2025 | The ACME Laboratories Ltd. Dhaka | BANGLADESH | ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED |
| 11/10/2025 | Kolmar Korea Co., Ltd. Bucheon Factory Bucheon | SOUTH KORE | HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED |
| 11/10/2025 | KOLMAR BNH CO.,LTD.(SBT) Sejong | SOUTH KORE | AVOBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED |
| 11/10/2025 | Kolmar Korea Co., Ltd. - Gwanjeong Factory Chungcheongnam-Do | SOUTH KORE | ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED |
| 11/10/2025 | Bayer S.A. Sao Paulo | BRAZIL | RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED |
| 11/10/2025 | Abbott Laboratorios do Brasil Ltda Sao Paulo | BRAZIL | VALPROATE SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED |
| 11/10/2025 | GELPHARMA S. A. DE C. V. Zapopan | MEXICO | VITAMIN, N.E.C. | 75UNAPPROVED |
| 11/10/2025 | LABORATORIO ALPHARMA PNT Azcapotzalco | MEXICO | ACARBOSE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED |
| 11/10/2025 | LABORATORIO SILANES Hidalgo | MEXICO | GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 11/10/2025 | Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) Tlajomulco De Zuniga | MEXICO | METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED |
| 11/10/2025 | ELANCO US INC Indianapolis | UNITED STA | TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 11/10/2025 | SANOTH CONSUMER HEALTHCARE INDIA Goa | INDIA | FEXOFENADINE HCL (ANTI-ASTHMATIC) | 75UNAPPROVED |
| 11/10/2025 | TANMED PHARMA IP Nagar | INDIA | NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 11/10/2025 | SUN PHARMA LABORATORIES LTD Assam | INDIA | LEVOCETIRIZINE DIHYDROCHLORIDE | 75UNAPPROVED |
| 11/10/2025 | ZYDUS MEDICA ZYDUS HEALTH CARE Ahmedabad | INDIA | DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED |
| 11/10/2025 | ELI LILLY CANADA INC Toronto | CANADA | TIRZEPATIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 11/10/2025 | SANDOZ CANADA INC Boucherville | CANADA | ESTRADIOL (ESTROGEN) | 75UNAPPROVED |
| 11/10/2025 | HELIX BIOPHARMA CORP Toronto | CANADA | ANTI-ECZEMATIC N.E.C. | 75UNAPPROVED |
| 11/10/2025 | HAYAT PHARMACEUTICAL IND Amman | JORDAN | CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS) | 75UNAPPROVED |
| 11/10/2025 | BGP PHARMA ULC Halifax | CANADA | PANCRELIPASE | 75UNAPPROVED |
| 11/10/2025 | Merz Pharmaceuticals GmbH Frankfurt Am Main | GERMANY | OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED |
| 11/10/2025 | Merz North America, Inc. Franksville | UNITED STA | OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED |
| 11/10/2025 | Takeda Canada Oakville | CANADA | VEDOLIZUMAB | 75UNAPPROVED |
| 11/10/2025 | Pfizer Ltd. Mumbai | INDIA | MEFENAMIC ACID (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 11/10/2025 | Pfizer Ltd. Mumbai | INDIA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 11/10/2025 | SUN PHARMA LABORATORIES LTD Karnruo | INDIA | LEVETIRACETAM (ANTI-CONVULSANT) | 75UNAPPROVED |
| 11/10/2025 | Auro Pharma Inc. Woodbridge | CANADA | TADALAFIL | 75UNAPPROVED |
| 11/10/2025 | IBTJ CO LTD Osaka | JAPAN | EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED |
| 11/10/2025 | GSK LABORATORIES Guatemala | GUATEMALA | ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED |
| 11/10/2025 | OMEGA NUTRITION Hidalgo Del Parral | MEXICO | VITAMIN, N.E.C. | 75UNAPPROVED |
| 11/10/2025 | NOVO NORDISK Mississauga | CANADA | SEMAGLUTIDE (ANTI-DIABETIC) | 75UNAPPROVED |
| 11/10/2025 | REYOUNG PHARCEUTICAL CO LTD San Pedro | HONDURAS | AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED |
| 11/10/2025 | REYOUNG PHARCEUTICAL CO LTD San Pedro | HONDURAS | IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED |
| 11/10/2025 | Ursapharm Arzneimittel GmbH Saarbrucken | GERMANY | DEXPANTHENOL (CHOLINERGIC) | 75UNAPPROVED |
| 11/10/2025 | PHARA SA Quetzaltenango | GUATEMALA | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 75UNAPPROVED |
| 11/10/2025 | LOPEZ LABORATORY Zona 10 | GUATEMALA | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 75UNAPPROVED |
| 11/10/2025 | LABORATORY PROMISE Guatemala | GUATEMALA | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS | 75UNAPPROVED |
| 11/10/2025 | MMG HEALTHCARE Pradesh | INDIA | CARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT | 75UNAPPROVED |
| 11/10/2025 | QUINFICA LABORATORY Guatemala | GUATEMALA | VITAMIN B12 (CYANOCOBALAMIN) | 75UNAPPROVED |
| 11/10/2025 | CNF CO., LTD. Gunpo | SOUTH KORE | OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED |
| 11/10/2025 | Seoul Cosmetics Co., Ltd. Namdong District | SOUTH KORE | OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 75UNAPPROVED |
| 11/10/2025 | Cosmecca Korea Co., Ltd. Eumseong | SOUTH KORE | CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED |
| 11/10/2025 | Ursapharm Arzneimittel GmbH Saarbrucken | GERMANY | MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED |
| 11/10/2025 | Viatris, Inc. Canonsburg | UNITED STA | LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED |
About This Page
This page displays 50 FDA import refusal records from 12 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 135 of 10,077 • Showing records 6,701-6,750 of 503,850 total