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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
12/8/2025MF COMERCIO FARMACEUTICO

Vila Velha

BRAZILTESTOSTERONE (ANDROGEN)
75UNAPPROVED
12/8/2025MF COMERCIO FARMACEUTICO

Vila Velha

BRAZILTESTOSTERONE (ANDROGEN)
75UNAPPROVED
12/8/2025MF COMERCIO FARMACEUTICO

Vila Velha

BRAZILSPIRONOLACTONE (DIURETIC)
75UNAPPROVED
12/8/2025MF COMERCIO FARMACEUTICO

Vila Velha

BRAZILTESTOSTERONE (ANDROGEN)
75UNAPPROVED
12/8/2025MF COMERCIO FARMACEUTICO

Vila Velha

BRAZILTADALAFIL
75UNAPPROVED
12/8/2025Eli Lilly Export S.A.

Vernier

SWITZERLANTIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
12/8/2025SAROKI AVENTIS OF MEXICO

Ocouoacac

MEXICONEOMYCIN PALMITATE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
12/8/2025LABORATORIO NOVARTIS CHILE SA

Santiago

CHILEENDOCRINE-METABOLIC AGENT, NEC
75UNAPPROVED
12/6/2025KARINLI INTERNATIONAL FOODS SAC

Lima

PERUSAUCES, N.E.C.
249FILTHY
12/5/2025JNCT INC

Surrey

CANADAPUMP, INFUSION
118NOT LISTED
3280FRNMFGREG
12/5/2025HANGZHOU BUS LOGISTICS TECHNOLOGY

Yiwu

CHINATOOTHBRUSH, MANUAL
118NOT LISTED
3280FRNMFGREG
12/5/2025VANNESSA VALDEZ NAVARRETE

Ciudad De Mexico

MEXICOMATERIAL, IMPRESSION
118NOT LISTED
3280FRNMFGREG
12/5/2025PASSIFLORA LIMITED

London

UNITED KINOVER-THE-COUNTER RADIOFREQUENCY COAGULATION DEVICE FOR WRINKLE REDUCTION
118NOT LISTED
3280FRNMFGREG
12/5/2025MLS MED SERVICES SDN BHD

Petaling Jaya

MALAYSIAASPIRATION THROMBECTOMY CATHETER
118NOT LISTED
3280FRNMFGREG
12/5/2025DILAN

Jungnang District

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
12/5/2025Nibec Co., Ltd.

Jincheon

SOUTH KOREEXPANDER, TISSUE, ORBITAL
118NOT LISTED
237NO PMA
+1 more
12/5/2025NAUTIUS INC

Santa Clara

UNITED STADENSITOMETER, BONE
118NOT LISTED
126FAILS STD
+2 more
12/5/2025LABORATORIOS SANTA FE S.A.

Guatemala

GUATEMALAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
118NOT LISTED
12/5/2025CONAMEP LABORATORY

Villa Nueva

GUATEMALAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
118NOT LISTED
12/5/2025LAFAGE

Guatemala

GUATEMALAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
12/5/2025IBEBU

Doum 5-Ro

SOUTH KOREAMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
12/5/2025RIVIEW LAB

Ahmedabad

INDIACLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
12/5/2025UNIMEDIA PHARMACEUTICALS

Ahmedabad

INDIACLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
12/5/2025AROVEA FORMULATIONS PVT. LTD.

Gujarat

INDIAMOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
12/5/2025BONSAI LIFE SCIENCES

Solan

INDIACLINDAMYCIN PHOSPHATE (LINCOMYCINS)
75UNAPPROVED
12/5/2025TRIOHIX CRITICAL CARE

Solan

INDIACEFIXIME (CEPHALOSPORINS)
75UNAPPROVED
12/5/2025BONSAI PHARMA

Solon

INDIALEVOCETIRIZINE DIHYDROCHLORIDE
75UNAPPROVED
12/5/2025SUCANTIS BIOTECH PVT

Karidwar

INDIAISOTRETINOIN (KERATOLYTIC)
75UNAPPROVED
12/5/2025MULTISTREAM LTD

Lagos

NIGERIAVITAMIN, N.E.C.
75UNAPPROVED
12/5/2025JIGSIMUR HEALTH PLUS DRINK

Cape Town

SOUTH AFRIVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
12/5/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICODICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
12/5/2025LABORATORY NEOETHICALS

Mixco

GUATEMALAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
12/5/2025GLAXOSMITHKLINE GUATEMALA SA

Ciudad Vieja

GUATEMALAMAGNESIUM SULFATE (ANTI-CONVULSANT)
75UNAPPROVED
12/5/2025LABORATORIO SAN CRSITOBAL

Guatemala

GUATEMALANAPROXEN (ANTI-INFLAMMATORY)
75UNAPPROVED
12/5/2025Farmacaps, S.A.

San Lucas

GUATEMALAIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
12/5/2025Laboratorios Farkot, S.A.

Guatemala City

GUATEMALAPHENYLEPHRINE HCL (ADRENERGIC)
75UNAPPROVED
12/5/2025Farmacaps, S.A.

San Lucas

GUATEMALADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
12/5/2025Laboratorios Roland Louis S.A.

Guatemala

GUATEMALAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
12/5/2025Sun Pharma Laboratories Ld

East-Sikkim

INDIACARVEDILOL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
12/5/2025Sangrose Laboratories Pvt. Ltd.

Mavelikara

INDIAVITAMIN B1 (THIAMINE)
75UNAPPROVED
12/5/2025LUPIN LTD

Sikkim

INDIAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
12/5/2025Morepen Laboratories Limited

Solan

INDIADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
12/5/2025ALKEM LABORATORIES

SIKKIM

INDIAMULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
75UNAPPROVED
12/5/2025Sun Pharma Laboratories Ltd

Dist Kamrup

INDIACLOPIDOGREL BISULFATE (ANTI-COAGULANT)
75UNAPPROVED
12/5/2025USV PVT LTD

Manjubar

INDIAMETFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
12/5/2025SUNGLOW LIFESCIENCE

Kattankulam

INDIAGABAPENTIN (ANTI-DEPRESSANT)
75UNAPPROVED
12/5/2025Samarth Life Sciences Pvt Ltd

Solan

INDIALEUCOVORIN CALCIUM (ANTI-ANEMIC)
75UNAPPROVED
12/5/2025Bajaj Healthcare Ltd

Vadodara

INDIASITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
75UNAPPROVED
12/5/2025SIDMAK LABORATORIES

Abrama

INDIANITROGLYCERIN (TAB) (VASODILATOR)
75UNAPPROVED
12/5/2025EMS PHARMA

Hortolandia

BRAZILCLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 15 countries. Records on this page involve violations including 75 (UNAPPROVED), 249 (FILTHY), 118 (NOT LISTED), 3280 (FRNMFGREG), 237 (NO PMA) and 2 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 34 of 10,038 • Showing records 1,651-1,700 of 501,854 total