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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
8/13/2025FARMAMEDICA SA

Guatemala

GUATEMALAVITAMIN, N.E.C.
75UNAPPROVED
8/13/2025NOVARTIS SOUTH AFRICA

Midrand

SOUTH AFRIMETFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
8/13/2025MARK (PTY) LTD

Modderfontein

SOUTH AFRIMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
8/13/2025Rottendorf Pharma Gmbh

Ennigerloh

GERMANYEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
8/13/2025Syntex

Morelos

MEXICONAPROXEN (ANTI-INFLAMMATORY)
75UNAPPROVED
8/13/2025HECHO EN MEXICO POR LABORATORIOS

Coyoacan

MEXICOACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
8/13/2025Arlex Mexico, S.A. de C.V.

Piloto

MEXICOIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
8/13/2025Kimberly-Clark De Mexico, S.A.B.

Ciudad De Mexico

MEXICOVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
8/13/2025HECHO EN MEXICO POR PRODUCTOS MA

Tlaquepaque

MEXICOBETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
8/13/2025PRODUCTOS FARMACEUTICOS

Jalisco

MEXICOLORATADINE (ANTI-ASTHMATIC)
75UNAPPROVED
8/13/2025LABORATORIOS SILANES SA DE CV

Toluca

MEXICOBENZONATATE (ANTI-TUSSIVE/COLD)
75UNAPPROVED
8/13/2025GENOMMALAB INTERNACIONAL

Ciudad De Mexico

MEXICOOMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
8/13/2025PRODUCTOS FARMACEUTICOS

Aguascalientes

MEXICOPERMETHRIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
75UNAPPROVED
8/13/2025NOVAG INFANCE SA DE CV

Mexico City

MEXICOITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
8/13/2025Farmaceutica Wandel S.A. de C.V.

Col. Ejidos de Padierna

MEXICODICLOXACILLIN (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
8/13/2025PRODUCTOS FARMACEUTICOS

Aguascalientes

MEXICODEXAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
8/13/2025ULTRA LABORATORIOS

Guadalajara

MEXICOFLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
8/13/2025LOROTEC

Guadalajara

MEXICOVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
8/13/2025MERCK INC

Taguig

PHILIPPINEMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
8/13/2025Boehringer Ingelheim

Makati City

PHILIPPINETELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
8/13/2025TORRENT PHARMACEUTICALS

Makati

PHILIPPINELOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
8/13/2025MSN Laboratories Private Limited - Formulations Division

Sangareddy

INDIAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
8/13/2025Novartis Farma S.P.A.

Torre Annunziata

ITALYEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
8/13/2025Pfizer Manufacturing Deutschland GmbH

Freiburg Im Breisgau

GERMANYAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
8/13/2025SILVINO HERNANDEZ PEREZ

Tejupilco Em

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/13/2025SILVINO HERNANDEZ PEREZ

Tejupilco Em

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/13/2025SILVINO HERNANDEZ PEREZ

Tejupilco Em

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/13/2025SILVINO HERNANDEZ PEREZ

Tejupilco Em

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/13/2025PRATI DONADUZZI LTDA

Toledo

BRAZILALBENDAZOLE (ANTIPARASITIC)
75UNAPPROVED
8/13/2025GRUPO YPENZA DE MEXICO SA DE CV

Zapopan

MEXICOFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
75UNAPPROVED
8/13/2025ULTRA LABORATORIOS

Guadalajara

MEXICOPIROXICAM (ANTI-INFLAMMATORY)
75UNAPPROVED
8/13/2025Productos Maver, S.A. de C.V.

Tlaquepaque

MEXICOBETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
8/13/2025LABORATORIOS GROSSMAN SA DE V

Deleg Coyoacan

MEXICOHYDROXOCOBALAMIN (VITAMIN)
75UNAPPROVED
8/13/2025Laboratorios Hormona

Obregon

MEXICOALBENDAZOLE (ANTIPARASITIC)
75UNAPPROVED
8/13/2025Laboratorios Hormona

Obregon

MEXICODIPYRONE (ANALGESIC)
75UNAPPROVED
8/13/2025Mylan Spa

Milan

ITALYLORAZEPAM (TRANQUILIZER)
75UNAPPROVED
8/13/2025ANGELINI PHARMA

Rome

ITALYACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
8/13/2025GLAXOSMITHKLINE SPA

Verona

ITALYAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
8/13/2025Emami Limited

Kolkata

INDIAMENTHOL (ANTI-PRURITIC)
75UNAPPROVED
8/13/2025RODIS

Lome

TOGOOTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.
75UNAPPROVED
8/13/2025El Paradis Cosmetique

Abidjan

IVORY COASCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
8/13/2025DREAM COSMETICS

Abigian

IVORY COASBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
8/13/2025Cabinet La Paix

Korhogo

IVORY COASMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
8/13/2025Nouvelle Parfumeria Gandour

Abidjan 01

IVORY COASBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
8/13/2025RODIS

Lome

TOGOFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
8/13/2025DREAM COSMETICS

Abigian

IVORY COASBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
8/13/2025H Cosmetics Ci Srl

Abidjan

IVORY COASOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
8/13/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
+1 more
8/13/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
8/13/2025INVERSIONES ASAD S DE RL DE CV

Yoro

HONDURASFLAVORED OR PARTY CRACKERS
11UNSAFE COL
274COLOR LBLG
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About This Page

This page displays 50 FDA import refusal records from 11 countries. Records on this page involve violations including 75 (UNAPPROVED), 11 (UNSAFE COL), 274 (COLOR LBLG), 320 (LACKS FIRM). Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 346 of 10,077 • Showing records 17,251-17,300 of 503,850 total