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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
6/30/2025Aprica Pharmaceuticals Pvt Ltd

Ahmedabad City

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/30/2025FRANCO INDIAN PHARMA PVT LTD

Ahmedabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/30/2025LIFESAN MEDICAL DEVICES INDIA PV

Mumbai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/30/2025PARRY PHARMA PVT LTD

Gujarat

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/30/2025ZENFO MED REMEDIES PRIVATE LIMIT

Hyderabad

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
6/30/2025Biocon Limited

Bangalore

INDIAINSULIN (INJ) (ANTI-DIABETIC)
75UNAPPROVED
6/30/2025Novo Nordisk

Bangalore

INDIAINSULIN (INJ) (ANTI-DIABETIC)
75UNAPPROVED
6/30/2025ARISTA PHARMACEUTICALS PVT LTD

Bangalore

INDIACEFTRIAXONE SODIUM (CEPHALOSPORINS)
75UNAPPROVED
6/30/2025Micro Labs Ltd

Bangalore

INDIAACENOCOUMAROL (ANTI-COAGULANT)
75UNAPPROVED
6/30/2025CILPA LTD

Mumbai

INDIAIPRATROPIUM BROMIDE (BRONCHODILATOR)
75UNAPPROVED
6/30/2025CILPA LTD

Mumbai

INDIABUDESONIDE (ANTI-ASTHMATIC)
75UNAPPROVED
6/30/2025GLAXO SMITHKLINE LTD

Mumbai

INDIACEFUROXIME SODIUM (CEPHALOSPORINS)
75UNAPPROVED
6/30/2025ALAMBIC

Vadodara

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
6/30/2025Sanofi India Ltd

Mumbai

INDIAFEXOFENADINE HCL (ANTI-ASTHMATIC)
75UNAPPROVED
6/30/2025SUN PHARMA INDUSTRIES LIMITED

Ranipool

INDIAMONTELUKAST SODIUM (ANTI-ASTHMATIC)
75UNAPPROVED
6/30/2025ALKEM LABORATORIES LTD

Mumbai

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
6/30/2025CELIA HERNANDEZ AGUIRRE

Jalisco

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/30/2025Eurofarma Laboratorios S.A.

Itapevi

BRAZILLITHIUM CARBONATE (ANTI-DEPRESSANT)
75UNAPPROVED
6/30/2025ZYDUS CADILA

Gandhinagar

INDIAVITAMIN B12 (CYANOCOBALAMIN)
75UNAPPROVED
6/30/2025Troikaa Pharmaceuticals Ltd

Ahmedabad

INDIADICYCLOMINE HCL (ANTI-CHOLINERGIC)
75UNAPPROVED
6/30/2025Allergan India Pvt Ltd

Bangalore

INDIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
6/30/2025Allergan India Pvt Ltd

Bangalore

INDIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
6/30/2025Troikaa Pharmaceuticals Ltd

Ahmedabad

INDIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
6/30/2025Troikaa Pharmaceuticals Ltd

Ahmedabad

INDIADOMPERIDONE
75UNAPPROVED
6/30/2025Mankind Pharma Ltd.

New Delhi

INDIAMONTELUKAST SODIUM (ANTI-ASTHMATIC)
75UNAPPROVED
6/30/2025ALLERGAN INDIA PRIVATE LIMITED

Bangalore

INDIAGLUCOCORTICOID N.E.C.
75UNAPPROVED
6/30/2025Mankind Pharma Ltd.

New Delhi

INDIALEVOFLOXACIN (ANTI-BACTERIAL, PART III)
75UNAPPROVED
6/30/2025Mankind Pharma Ltd.

New Delhi

INDIACHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC)
75UNAPPROVED
6/30/2025Mankind Pharma Ltd.

New Delhi

INDIACEFPODOXIME PROXETIL (CEPHALOSPORINS)
75UNAPPROVED
6/30/2025RECKITT BENKISER

Gurugram

INDIACHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
6/30/2025ASCADE INDIA PHARMA

Pradesh

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
6/30/2025ITC LIMITED

Kolkata

INDIACHLORHEXIDINE GLUCONATE
75UNAPPROVED
6/30/2025SAF FERMION LTD

Bengal

INDIAPOVIDONE IODINE (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
6/30/2025SUN PHARMA LAB

Kokhjhar

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
6/30/2025OIOCURIS PHARMA PVT

Ranipool

INDIAKETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY)
75UNAPPROVED
6/30/2025SANOFI CONSUMER HEALTHCARE INDIA

Ahmedabad

INDIAFEXOFENADINE HCL (ANTI-ASTHMATIC)
75UNAPPROVED
6/30/2025EXCEL HEALTHCARE

Mumbai

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
6/30/2025SHANDONG ZHENFU MEDICAL DEVICE C

Rizhao City

CHINAGENERAL PURPOSE REAGENT
75UNAPPROVED
6/30/2025SAMIR KOJAK SONS COMPANY

Damascus

SYRIACORE FRUIT JAM/JELLY CANDIED (PRICKLE PEAR CACTUS)
62NEEDS FCE
6/30/2025SAMIR KOJAK SONS COMPANY

Damascus

SYRIACORE FRUIT JAM/JELLY CANDIED (PRICKLE PEAR CACTUS)
62NEEDS FCE
6/30/2025SAMIR KOJAK SONS COMPANY

Damascus

SYRIACORE FRUIT JAM/JELLY CANDIED (PRICKLE PEAR CACTUS)
62NEEDS FCE
6/30/2025Glenmark Pharmaceuticals Limited

Solan

INDIAGUAIFENESIN (EXPECTORANT)
27DRUG GMPS
6/30/2025Intas Pharmaceuticals Limited

Ahmedabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
6/30/2025TOUKAI TSUKEMONO CO., LTD TAHARA PLANT.

ATSUMI-GUN

JAPANGINGER ROOT (ROOT & TUBER VEGETABLE)
11UNSAFE COL
274COLOR LBLG
6/30/2025SANMING CHUSHEN FOOD CO, LTD

Sanming

CHINANOODLES, INSTANT
9SALMONELLA
6/30/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
6/30/2025SAHARA PIONEER VENTURES

Accra

GHANAMELON SEEDS (EDIBLE SEED)
9SALMONELLA
6/30/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
6/30/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
6/30/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
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About This Page

This page displays 50 FDA import refusal records from 8 countries. Records on this page involve violations including 75 (UNAPPROVED), 62 (NEEDS FCE), 27 (DRUG GMPS), 11 (UNSAFE COL), 274 (COLOR LBLG) and 2 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 433 of 10,077 • Showing records 21,601-21,650 of 503,850 total