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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
6/20/2025Titanium Technologies (India) Pvt. Ltd.A

District Alwar

INDIAVITAMIN, N.E.C.
75UNAPPROVED
6/20/2025ELI LILLY AND COMPANY LIMITED

Twickenham

UNITED KINTIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
6/20/2025E-DARMA PHARMA INDIA PVT LTD

Mumbai

INDIAOXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN)
75UNAPPROVED
6/20/2025TM Thakore Pharmaceutical Laboratories

Mumbai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/20/2025TM Thakore Pharmaceutical Laboratories

Mumbai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/20/2025ADDII BIOTECH PVT LTD

Solan

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/20/2025E-DARMA PHARMA INDIA PVT LTD

Mumbai

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/20/2025MALIK LIFESCIENCE PVT. LTD

UTTARAKHAND

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/20/2025VIOCECH FORMULATIONS

Karnal

INDIAMETHYLPREDNISOLONE (GLUCOCORTICOID)
75UNAPPROVED
6/20/2025Terrace Pharmaceuticals Private Limited

Sansarpur

INDIABETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
6/20/2025Lanark Laboratories

Sahib

INDIAFEXOFENADINE HCL (ANTI-ASTHMATIC)
75UNAPPROVED
6/20/2025LEEFORD HEALTHCARE LTD

Tehsill Baddi

INDIACLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
6/20/2025ZEISS PHARMA LIMITED

SAMBA

INDIACEPHALEXIN (CEPHALOSPORINS)
75UNAPPROVED
6/20/2025DR REDDYS LABS

Hyderabad

INDIAANTI-DIURETIC N.E.C.
75UNAPPROVED
6/20/2025Apex Laboratories Ltd

Chennai City Corporation

INDIAONDANSETRON (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
6/20/2025ZYDUS HEALTHCARE LIMITED PLOT

Ahmedabad

INDIAREPLENISHER N.E.C.
75UNAPPROVED
6/20/2025FDC LTD

Maharashtra

INDIABENZOCAINE (ANESTHETIC)
75UNAPPROVED
6/20/2025GLAXO SMITHKLEIN

Pradesh

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
6/20/2025Akums Drugs & Pharma

Ranipur

INDIACHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC)
75UNAPPROVED
6/20/2025ARISTO PHARMACEUTICALS PVT LTD

Hyderabad

INDIAMUCOLYTIC N.E.C.
75UNAPPROVED
6/20/2025HEMA LABORATORIES

Uttarakhand

INDIAMETRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
6/20/2025MEDREICH LTC

Bangalore

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
6/20/2025MIRCO LAB LIMITED

South Sikkim

INDIAAMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
6/20/2025Cosmax Inc

Gyeonggi-do

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
6/20/2025LABORATOIRES BAILLEUL SA

Bailleul

LUXEMBOURGTRETINOIN (KERATOLYTIC)
75UNAPPROVED
6/20/2025AYURVEDA PVT LTD

Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
6/20/2025TORONTO RESEARCH CHEMICALS INC

North York

CANADAXYLAZINE HCL (ANALGESIC)
75UNAPPROVED
6/20/2025Kalvert Foods India Pvt Ltd

Mumbai

INDIASYRUPS AND MOLASSES, N.E.C.
11UNSAFE COL
274COLOR LBLG
6/20/2025Fromagerie P.Jacquin & Fils

La Vernelle

FRANCESOFT RIPENED CHEESE MADE FROM GOAT'S MILK (E.G., CHEVRE, FETA, GOAT)
11UNSAFE COL
274COLOR LBLG
6/20/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+1 more
6/20/2025BRITISH AMERICAN TOBACCO

Malmo

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
39053905
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
6/20/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
6/20/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
6/20/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB

About This Page

This page displays 50 FDA import refusal records from 8 countries. Records on this page involve violations including 75 (UNAPPROVED), 11 (UNSAFE COL), 274 (COLOR LBLG), 3842 (TP NO PMTA), 3843 (TP NO SE) and 4 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 448 of 10,077 • Showing records 22,351-22,400 of 503,850 total