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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
8/22/2025Aspen Pharmacare

Woodmead

SOUTH AFRIHYDROCHLOROTHIAZIDE (DIURETIC)
75UNAPPROVED
8/22/2025Orion Corporation, Orion Pharma

Espoo

FINLANDLEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
8/22/2025GLENNA GIBBONS

Toronto

CANADAALLOPURINOL SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
8/22/2025GLENNA GIBBONS

Toronto

CANADABUPROPION HCL (ANTI-DEPRESSANT)
75UNAPPROVED
8/22/2025Novo Nordisk Pharmaceutical

Sao Paulo

BRAZILSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
8/22/2025LIBBS FARMACEUTICA

Sao Paulo

BRAZILBUSPIRONE HCL (TRANQUILIZER)
75UNAPPROVED
8/22/2025LUNDBECK

Rio De Janeiro

BRAZILESCITALOPRAM OXALATE
75UNAPPROVED
8/22/2025RAYMUNDO DIAZ BORJA

Cuernavaca

MEXICOBRONCHODILATOR N.E.C.
75UNAPPROVED
8/22/2025ZYDOS HEALTHCARE LTD

Bhasmay

INDIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
8/22/2025SUN PHARMA LABORATORIES LTD

Assam

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
8/22/2025ZYDOS HEALTHCARE LTD

Bhasmay

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
8/22/2025ABOTT HEALTHCARE

Solan

INDIAFEBUXOSTAT (XANTHINE OXIDASE INHIBITOR)
75UNAPPROVED
8/22/2025HANDOK

Seoul

SOUTH KORECLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
75UNAPPROVED
8/22/2025HANMI PHARM. CO., LTD.

Hwaseong

SOUTH KOREISOTRETINOIN (KERATOLYTIC)
75UNAPPROVED
8/22/2025Popular Pharmaceuticals Ltd

Tongi

BANGLADESHCABERGOLINE (ANTI-PARKINSONIAN)
75UNAPPROVED
8/22/2025Donovan Werke

Guatemala

GUATEMALADICYCLOMINE HCL (ANTI-CHOLINERGIC)
75UNAPPROVED
8/22/2025Donovan Werke

Guatemala

GUATEMALAPIROXICAM (ANTI-INFLAMMATORY)
75UNAPPROVED
8/22/2025Donovan Werke

Guatemala

GUATEMALADEXAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
8/22/2025Merck

Guatamala

GUATEMALAIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
8/22/2025Merck

Guatamala

GUATEMALAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
8/22/2025Square Pharmaceuticals PLC

Gazipur

BANGLADESHROSUVASTATIN CALCIUM
75UNAPPROVED
8/22/2025DRUG INTERNATIONAL LTD

Dhaka

BANGLADESHMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
8/22/2025LEO PHARMA LTDA

Sao Paulo

BRAZILMETHYLPREDNISOLONE (GLUCOCORTICOID)
75UNAPPROVED
8/22/2025Thermadyne Victor Ltda.

Rio De Janeiro

BRAZILTRETINOIN (KERATOLYTIC)
75UNAPPROVED
8/22/2025SANDOZ

Sao Paulo

BRAZILDIPYRONE (ANALGESIC)
75UNAPPROVED
8/22/2025MANIPULATION PHARMACY

Limeira

BRAZILDROSPIRENONE
75UNAPPROVED
8/22/2025TORRENT PHARMA

Santo Amaro

BRAZILLAMOTRIGINE (ANTI-CONVULSANT)
75UNAPPROVED
8/22/2025BIO LIFE SA DE CV

Monterrey

MEXICOVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
8/22/2025Abbvie Biotechnology Gmbh

Ludwigshafen Am Rhein

GERMANYADALIMUMAB
75UNAPPROVED
8/22/2025SANOF MEDLEY FARM LTDA

Sao Paulo

BRAZILANALGESIC, N.E.C.
75UNAPPROVED
8/22/2025Eli Lilly

Fegersheim

FRANCETIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
8/22/2025Qingdao BAHEAL Pharmaceutical Co.,Ltd.

Qingdao

CHINAMETFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
8/22/2025Novo Nordisk Pharmaceutical Industries LP

Clayton

UNITED STASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
8/22/2025Novo Nordisk Pharmaceutical Industries LP

Clayton

UNITED STAINSULIN SUSP ISOPHANE/INSULIN BIOSYN HUM (ANTI-DIABETIC)
75UNAPPROVED
8/22/2025DAVIS SA

Guatemala City

GUATEMALAVITAMIN K (PHYTONADIONE)
75UNAPPROVED
8/22/2025Quinfica Nutramedics Boldo

Guatemala

GUATEMALAVITAMIN B12 (CYANOCOBALAMIN)
75UNAPPROVED
8/22/2025LANKETIN

Guatemala City

GUATEMALAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
8/22/2025Quinfica Nutramedics Boldo

Guatemala

GUATEMALASODIUM ASCORBATE (VITAMIN)
75UNAPPROVED
8/22/2025MPL AEREO /MASSIEL GONZALEZ

Miami

UNITED STAGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
8/22/2025ESPECIFER FERRAMENTAS E EQUIPAMENTOS ESPECIAIS

Indaiatuba

BRAZILALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS
47NON STD
8/22/2025Similasan AG

Jonen

SWITZERLANEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
27DRUG GMPS
8/22/2025DESDE EL CORAZON DEL FRUTO

Del. Cuauhtemoc

MEXICOPUNCH DRINK, CARBONATED
11UNSAFE COL
324NO ENGLISH
+1 more
8/22/2025BARCEL, S.A. DE C.V

Pueblo Infonavit Lerma

MEXICOPOTATO CHIPS,FRIED
11UNSAFE COL
274COLOR LBLG
+1 more
8/22/2025BARCEL, S.A. DE C.V

Pueblo Infonavit Lerma

MEXICOPOTATO CHIPS,FRIED
11UNSAFE COL
274COLOR LBLG
+1 more
8/22/2025Fritos Totis, S.A. de C.V.

Tizayuca

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
+1 more
8/22/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
8/22/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
8/22/2025DESDE EL CORAZON DEL FRUTO

Del. Cuauhtemoc

MEXICOPUNCH DRINK, CARBONATED
11UNSAFE COL
218LIST INGRE
+4 more
8/22/2025Fritos Totis, S.A. de C.V.

Tizayuca

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
218LIST INGRE
+2 more
8/22/2025Mametaro Co.,LTD

Honjo

JAPANGINGER ROOT (ROOT & TUBER VEGETABLE)
11UNSAFE COL

About This Page

This page displays 50 FDA import refusal records from 15 countries. Records on this page involve violations including 75 (UNAPPROVED), 47 (NON STD), 27 (DRUG GMPS), 11 (UNSAFE COL), 324 (NO ENGLISH) and 6 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 327 of 10,077 • Showing records 16,301-16,350 of 503,850 total