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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
7/2/2025HONG KONG ZOEY TRADING CO.,LIMITED

Hong Kong

HONG KONGMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
7/2/2025Fei Fah Medical Manufacturing Pte. Ltd.

Singapore

SINGAPOREHOMEOPATHIC ANALGESIC
118NOT LISTED
3280FRNMFGREG
+1 more
7/2/2025SPECS HUB

Karachi

PAKISTANLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
118NOT LISTED
3280FRNMFGREG
7/2/2025Isehan Co Ltd

Tokyo

JAPANULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
3280FRNMFGREG
7/2/2025Xenex Laboratories Inc.

Coquitlam

CANADAMENTHOL (ANTI-PRURITIC)
118NOT LISTED
7/2/2025ARAMEX- TRANSIT

Slough

UNITED KINTADALAFIL
75UNAPPROVED
7/2/2025FRAN TAILOR

Winnipeg

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
7/2/2025ZENITH DRINKS PVT LTD

New Delhi

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
7/2/2025DR REDDY LAB LTD

Baddi

INDIAMESALAMINE (ANALGESIC)
75UNAPPROVED
7/2/2025Reliance Life Sciences Private Limited

Navi Mumbai

INDIAEPOETIN ALFA
75UNAPPROVED
7/2/2025PFIZER IRELAND

Dublin

IRELANDAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
7/2/2025CADILA PHARMA LTD

Ahmedabad

INDIAHYDROQUINONE (DEPIGMENTOR)
75UNAPPROVED
7/2/2025SUN PHARMA

Mumbai

INDIATRANEXAMIC ACID (HEMOSTATIC)
75UNAPPROVED
7/2/2025Sun Pharmaceutical Industries Ltd

Mumbai

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
7/2/2025CIPLA

Hyderabad

INDIACETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC)
75UNAPPROVED
7/2/2025Ranbaxy Laboratory Ltd

Mumbai

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
7/2/2025ABBOTT INDIA

Mumbai

INDIALEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
7/2/2025Catalent Italy S.p.A.

Aprilia

ITALYDIMETHYL SULFOXIDE (ANTI-INFLAMMATORY)
75UNAPPROVED
7/2/2025NEOLPHARMA SA DE CV

Mexico City

MEXICOTELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
7/2/2025VICTORY ENTERPRISES SA

Tijuana

MEXICOAMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
7/2/2025Hetero Labs Ltd

Sanath Nagar

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
7/2/2025NEOLPHARMA SA DE CV

Mexico City

MEXICOASPIRIN (ANALGESIC)
75UNAPPROVED
7/2/2025LABORATORIO AVIVIA LAB

Mexico City

MEXICORISEDRONATE SODIUM (BONE CALCIUM REGULATOR)
75UNAPPROVED
7/2/2025Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield

UNITED STAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
7/2/2025GEOLAB

Anapolis

BRAZILITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
7/2/2025Mylan Laboratories Ltd.

Hyderabad

INDIALEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
7/2/2025Laboratorios Grossman, S.A.

Ciudad De Mexico

MEXICOLIOTHYRONINE SODIUM (THYROID HORMONE)
75UNAPPROVED
7/2/2025Monteverde Sa

Prov San Juan

ARGENTINADESVENLAFAXINE SUCCINATE
75UNAPPROVED
7/2/2025LILLY MEDICAL

Trujillo Bajo

UNITED STAOLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II
75UNAPPROVED
7/2/2025BOEHRINGER INGELHEIM FOR NOVO NO

Bagsvard

DENMARKSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
7/2/2025FOUNDATION OSWALDO CRUZ

Rio De Janeiro

BRAZILSIROLIMUS (IMMUNOSUPPRESSIVE)
75UNAPPROVED
7/2/2025FOUNDATION OSWALDO CRUZ

Rio De Janeiro

BRAZILTACROLIMUS (IMMUNOSUPPRESSIVE)
75UNAPPROVED
7/2/2025SCOTT-EDIL PHARMACIA LTD

Baddi

INDIAVITAMIN D2 (CALCIFEROL)
75UNAPPROVED
7/2/2025TORRENT PHARMA LIMITED

Sikkim

INDIAMECOBALAMIN (VITAMIN)
75UNAPPROVED
7/2/2025SADHYA AYURVED PHARMACY

Ahmedabad

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
7/2/2025AMSTER LABS

Solan

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
7/2/2025Laboratorios Farma

Maracaymaracay

VENEZUELACHLORTHALIDONE (DIURETIC)
75UNAPPROVED
7/2/2025LABORATORY FC

Asuncion

PARAGUAYCANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
7/2/2025Zentiva Group, a.s.

Prague

CZECH REPUROSUVASTATIN CALCIUM
75UNAPPROVED
7/2/2025AIC MENARINI INTERNATIONAL

Luxemburg City

LUXEMBOURGGLIPIZIDE (ANTI-DIABETIC)
75UNAPPROVED
7/2/2025Eurofarma Laboratorios S.A.

Itapevi

BRAZILRISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
7/2/2025Eurofarma Laboratorios S.A.

Itapevi

BRAZILLITHIUM (ANTI-DEPRESSANT)
75UNAPPROVED
7/2/2025Eurofarma Laboratorios S.A.

Itapevi

BRAZILESCITALOPRAM OXALATE
75UNAPPROVED
7/2/2025Gelpharma S.A. de C.V.

Zapopan

MEXICOCALCITRIOL (ANTI-HYPERCALCEMIC)
75UNAPPROVED
7/2/2025PRODUCTOS MAVER SA DE CV

Guadalajara

MEXICOBUMETANIDE (DIURETIC)
75UNAPPROVED
7/2/2025LABORATORIOS SILANES SA DE CV

Toluca

MEXICOANTI-HYPERLIPIDEMIC N.E.C.
75UNAPPROVED
7/2/2025PSICOFARMA S.A. DE C.V.

Cuidad de Mexico

MEXICOPRAVASTATIN SODIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
7/2/2025MEGALABS COLOMBIA SAS

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/2/2025LABORATPRIOS MK S.A.S

Cali

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
7/2/2025INVIMA DE LABORATORIO

Barranquilla

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 19 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 75 (UNAPPROVED). Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 429 of 10,077 • Showing records 21,401-21,450 of 503,850 total