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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
12/17/2025MEGABUSINESS PERU S.A.C.

Ventanilla

PERUPEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)
241PESTICIDE
12/17/2025Empresas Villar Concepcion

La Vega

DOMINICAN PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)
241PESTICIDE
12/17/2025Empresas Villar Concepcion

La Vega

DOMINICAN PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)
241PESTICIDE
12/17/2025MEGABUSINESS PERU S.A.C.

Ventanilla

PERUPEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)
241PESTICIDE
12/17/2025Kahi & Qaymer Al-baghdadi Inc.

Windsor

CANADAMILK AND CREAM, N.E.C.
218LIST INGRE
321LACKS N/C
+2 more
12/17/2025NELL TRADING LIMITED

Cheung Sha Wan

HONG KONGLENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
3280FRNMFGREG
+1 more
12/17/2025VYSOTSKA VIKTORIIA ANDRIIVNA

Warsaw

POLANDSTERILIZER, STEAM
118NOT LISTED
3280FRNMFGREG
+1 more
12/17/2025BECTON DICKINSON

Gurgaon

INDIAINTRODUCER, SYRINGE NEEDLE
118NOT LISTED
3280FRNMFGREG
+1 more
12/17/2025Lianshui Huisheng Imp & Exp Co Ltd

Lianshui Jaingsu

CHINABANDAGE, ELASTIC
118NOT LISTED
3280FRNMFGREG
+1 more
12/17/2025Lianshui Huisheng Imp & Exp Co Ltd

Lianshui Jaingsu

CHINABANDAGE, ELASTIC
118NOT LISTED
3280FRNMFGREG
+1 more
12/17/2025Laboratorios Vijosa, S.A. de C.V.

Antiguo Cuscatlan

EL SALVADOACETAMINOPHEN (ANALGESIC)
118NOT LISTED
3280FRNMFGREG
+1 more
12/17/2025SUNRISED MEDICAL GMBH & CO KG

Malsch

GERMANYCOMPONENTS, WHEELCHAIR
118NOT LISTED
3280FRNMFGREG
12/17/2025SUNRISED MEDICAL GMBH & CO KG

Malsch

GERMANYCOMPONENTS, WHEELCHAIR
118NOT LISTED
3280FRNMFGREG
12/17/2025SUNRISED MEDICAL GMBH & CO KG

Malsch

GERMANYCOMPONENTS, WHEELCHAIR
118NOT LISTED
3280FRNMFGREG
12/17/2025SUNRISED MEDICAL GMBH & CO KG

Malsch

GERMANYCOMPONENTS, WHEELCHAIR
118NOT LISTED
3280FRNMFGREG
12/17/2025SUNRISED MEDICAL GMBH & CO KG

Malsch

GERMANYCOMPONENTS, WHEELCHAIR
118NOT LISTED
3280FRNMFGREG
12/17/2025SUNRISED MEDICAL GMBH & CO KG

Malsch

GERMANYCOMPONENTS, WHEELCHAIR
118NOT LISTED
3280FRNMFGREG
12/17/2025Lactona Europe

Bergen Op Zoom

NETHERLANDTOOTHBRUSH, MANUAL
118NOT LISTED
3280FRNMFGREG
12/17/2025NINEONECOSMEDI

Gwangju Si Bu

SOUTH KOREULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
3280FRNMFGREG
12/17/2025B-K Medical A/S

Herlev

DENMARKNEEDLE CATHETER JEJUNOSTOMY KIT
118NOT LISTED
3280FRNMFGREG
12/17/2025Seed Company, Ltd.

Bunkyo

JAPANCASE, CONTACT LENS
118NOT LISTED
237NO PMA
+2 more
12/17/2025Westcomb Outerwear

Vancouver

CANADALENS, CONTACT (OTHER MATERIAL) - DAILY
118NOT LISTED
237NO PMA
+1 more
12/17/2025LABORATORY ECOMED

San Salvador

EL SALVADOMETFORMIN (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
12/17/2025PRAMELA, TERA LIDIA

Hyderabad

INDIAROSUVASTATIN CALCIUM
118NOT LISTED
75UNAPPROVED
12/17/2025SUN PHARMA LABORATORIES LTD

Palasbari

INDIALEVETIRACETAM (ANTI-CONVULSANT)
118NOT LISTED
75UNAPPROVED
12/17/2025SUN PHARMA LABORATORIES LTD

Palasbari

INDIAVALPROATE SODIUM (ANTI-CONVULSANT)
118NOT LISTED
75UNAPPROVED
12/17/2025Tecnoquimicas S.A.

San Nicolas Cali

COLOMBIAVALSARTAN (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
75UNAPPROVED
12/17/2025MARCILIO DE ALMEIDA PEREIRA

Sabara

BRAZILISOTRETINOIN (KERATOLYTIC)
118NOT LISTED
75UNAPPROVED
12/17/2025MARCILIO DE ALMEIDA PEREIRA

Sabara

BRAZILANTI-INFLAMMATORY N.E.C.
118NOT LISTED
75UNAPPROVED
12/17/2025MARCILIO DE ALMEIDA PEREIRA

Sabara

BRAZILMETRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
118NOT LISTED
75UNAPPROVED
12/17/2025PISA SA DE CV

Jalisco

MEXICOURSODIOL (CHOLINERGIC)
118NOT LISTED
75UNAPPROVED
12/17/2025LABORATORIOS SENOSIAIN SA DE CV

Chapultepec

MEXICOSUCRALFATE (ANTACID)
118NOT LISTED
75UNAPPROVED
12/17/2025Laboratorios Bioserum Mexico, S.A. de C.V.

Xochimanca

MEXICOLEVOTHYROXINE SODIUM (THYROID HORMONE)
118NOT LISTED
75UNAPPROVED
12/17/2025F. Hoffmann - La Roche Ltd.

Kaiseraugst

SWITZERLANISOTRETINOIN (KERATOLYTIC)
118NOT LISTED
75UNAPPROVED
12/17/2025Bgp Pharma Ulc

Etobicoke

CANADALEVOTHYROXINE SODIUM (THYROID HORMONE)
118NOT LISTED
75UNAPPROVED
12/17/2025Pfizer Canada Inc. - Kirkland, QC Administrative Site

Kirkland

CANADACONJUGATED ESTROGENS (ESTROGEN)
118NOT LISTED
75UNAPPROVED
12/17/2025laboratorio Qualipharm

de Guatemala

GUATEMALADOXYLAMINE SUCCINATE (ANTI-HISTAMINIC)
118NOT LISTED
75UNAPPROVED
12/17/2025ELI LILLY CANADA

Toronto

CANADATIRZEPATIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
12/17/2025VIIV HEALTHCARE ULC

Montreal

CANADAABACAVIR SULFATE; DOLUTEGRAVIR; LAMIVUDINE (ANTI-VIRAL)
118NOT LISTED
75UNAPPROVED
12/17/2025SANDOZ CANADA INCORPORATED

Saint-Hubert

CANADAAPIXABAN (ANTI-COAGULANT)
118NOT LISTED
75UNAPPROVED
12/17/2025ASTRAZENECA PHARMA

BANGALORE

INDIALIDOCAINE (ANESTHETIC)
118NOT LISTED
75UNAPPROVED
12/17/2025Bristol-Myers Squibb Manufacturing Company Unlimited Company

Humacao

UNITED STAAPIXABAN (ANTI-COAGULANT)
118NOT LISTED
75UNAPPROVED
12/17/2025SANDOZ CANADA INCORPORATED

Saint-Hubert

CANADAAPIXABAN (ANTI-COAGULANT)
118NOT LISTED
75UNAPPROVED
12/17/2025Amgen, Inc.

Thousand Oaks

UNITED STAROMOSOZUMAB-AQQG
118NOT LISTED
75UNAPPROVED
12/17/2025Synokem Pharmaceuticals Ltd

Haridwar

INDIAROSUVASTATIN CALCIUM
118NOT LISTED
12/17/2025SL SAMARTH LIFE SCIENCES PVT LTD

Pradesh

INDIAPYRIDOSTIGMINE BROMIDE (CHOLINERGIC)
118NOT LISTED
12/17/2025Sanofi Winthrop Industrie

Carbon Blanc CEDEX

FRANCECLOPIDOGREL BISULFATE (ANTI-COAGULANT)
118NOT LISTED
12/17/2025Windlas Biotech Ltd

Dehradun

INDIAMETOPROLOL (ANTI-ADRENERGIC)
118NOT LISTED
12/17/2025Cadila Pharmaceuticals Limited

Ahmedabad

INDIAVITAMIN, N.E.C.
118NOT LISTED
12/17/2025UNIVERSAL NUTRISCIENCE

Mumbai

INDIAEVENING PRIMROSE OIL (FATS AND LIPID SUBSTANCES)
118NOT LISTED

About This Page

This page displays 50 FDA import refusal records from 20 countries. Records on this page involve violations including 241 (PESTICIDE), 218 (LIST INGRE), 321 (LACKS N/C), 328 (USUAL NAME), 3300 (ALLERGEN) and 5 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 16 of 10,038 • Showing records 751-800 of 501,854 total