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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
11/14/2025Viatris Pharmaceuticals LLC

Vega Baja

UNITED STAVENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT)
118NOT LISTED
75UNAPPROVED
11/14/2025Eli Lilly

Indianapolis

UNITED STALISPRO INSULIN (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
11/14/2025MEMPHIS

Bogota

COLOMBIAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
75UNAPPROVED
11/14/2025PROCTER & GAMBLE HEALTH LTD

Verna Goa

INDIALEVOCARNITINE (NUTRIENT/TONIC)
118NOT LISTED
75UNAPPROVED
11/14/2025ALLERGAN INDIA PVT

Pvt

INDIAOMEGA-3-ACID ETHYL ESTERS (ANTI-HYPERLIPIDEMIC)
118NOT LISTED
75UNAPPROVED
11/14/2025GALDERMA INDIA

D Wng

INDIADESONIDE (ANTI-INFLAMMATORY)
118NOT LISTED
75UNAPPROVED
11/14/2025PROCTER & GAMBLE HEALTH LTD

Verna Goa

INDIALEVOCARNITINE (NUTRIENT/TONIC)
118NOT LISTED
75UNAPPROVED
11/14/2025DR REDDY LABORTORIES

Baddi

INDIAOMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
118NOT LISTED
75UNAPPROVED
11/14/2025HEDGE AND HEDGE PHARMACEUTICALS

Mumbai

INDIACLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
118NOT LISTED
75UNAPPROVED
11/14/2025SUN PHARMACEUTICAL

Ri

INDIADAPAGLIFLOZIN (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
11/14/2025JB CHEMICALS

Gidc

INDIAMETRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
118NOT LISTED
75UNAPPROVED
11/14/2025SUN PHARMAEUTICALS

Nandon

INDIAMONTELUKAST SODIUM (ANTI-ASTHMATIC)
118NOT LISTED
75UNAPPROVED
11/14/2025KLM LAB PVT LTD

Mumbai

INDIAMINOXIDIL (ANTI-HYPERTENSIVE)
118NOT LISTED
75UNAPPROVED
11/14/2025NOVARTIS PHARMACEUTICALS CANADA

Montreal

CANADAANTI-INFLAMMATORY N.E.C.
118NOT LISTED
75UNAPPROVED
11/14/2025ASTHA HOSPITAL

Jalandhar

INDIAOXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
118NOT LISTED
75UNAPPROVED
11/14/2025BEST S A

Benito Juarez

MEXICODICLOFENAC SODIUM (ANTI-INFLAMMATORY)
118NOT LISTED
75UNAPPROVED
11/14/2025ULTRA LABORATORIOS

Guadalajara

MEXICOESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
118NOT LISTED
75UNAPPROVED
11/14/2025ANTIBIOTICOS DE MEXICO, S.A. DE

Coyoacan

MEXICOAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
118NOT LISTED
75UNAPPROVED
11/14/2025Antibioticos de Mexico S.A. de C.V.

Ciudad De Mexico

MEXICOAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
118NOT LISTED
75UNAPPROVED
11/14/2025Cooperation Pharmaceutique Francaise

Melun

FRANCEALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
11/14/2025Cosmetique Active Production

Creuzier-le-vieux

FRANCEOTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
75UNAPPROVED
11/14/2025Zenith Drinks Pvt.Ltd.

New Delhi

INDIADIETARY CONVENTIONAL FOODS, N.E.C.
75UNAPPROVED
11/14/2025PISA SA DE CV

Guadalajara

MEXICOSODIUM CITRATE (ALKALIZER)
75UNAPPROVED
11/14/2025GRIMMAN SA DE CV

Pueblo Infonavit Lerma

MEXICOPROGESTERONE (PROGESTIN)
75UNAPPROVED
11/14/2025PISA SA DE CV

Guadalajara

MEXICOSODIUM CITRATE (ALKALIZER)
75UNAPPROVED
11/14/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICODICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
11/14/2025TIENDA NATURISTA DE URUAPAN

Uruapan

MEXICOMENTHOL (ANTI-PRURITIC)
75UNAPPROVED
11/14/2025Importadora y Manufacturera Burluart S.A.

Tultitlan

MEXICOVITAMIN B6 (PYRIDOXINE)
75UNAPPROVED
11/14/2025Boehringer Ingelheim Canada

Burlington

CANADAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
11/14/2025Boehringer Ingelheim Canada

Burlington

CANADAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
11/14/2025Amgen Canada Inc

Mississauga

CANADAETANERCEPT
75UNAPPROVED
11/14/2025NOVARTIS PHARMACEUTICALS CANADA

Montreal

CANADAOMALIZUMAB
75UNAPPROVED
11/14/2025GLAXOSMITHKLINE

Mississauga

CANADAFLUTICASONE PROPIONATE (BRONCHODILATOR)
72NEW VET DR
11/14/2025ELI LILLY CANADA INC

Toronto

CANADAINSULIN GLARGINE
72NEW VET DR
11/14/2025Taizhou Kangping Medical Science And Technology Co., Ltd.

Taizhou

CHINAISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
27DRUG GMPS
11/14/2025Taizhou Kangping Medical Science And Technology Co., Ltd.

Taizhou

CHINAISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
27DRUG GMPS
11/14/2025Taizhou Kangping Medical Science And Technology Co., Ltd.

Taizhou

CHINAISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
27DRUG GMPS
11/14/2025Zalal Mowafaq

Herat

AFGHANISTAENERGY DRINK CAFFEINE, NONCARBONATED, N.E.C.
11UNSAFE COL
274COLOR LBLG
+2 more
11/14/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/14/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
11/14/2025GHRAWI GROUP FOR CHOCOLATE & SWEETS CO., SAL

Kfarshima

LEBANONCHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT
11UNSAFE COL
260FALSE
+3 more
11/14/2025Swizzels Matlow Limited

High Peak

UNITED KINLICORICE CANDY, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
11/14/2025Swizzels Matlow Limited

High Peak

UNITED KINCANDY WITHOUT CHOCOLATE N.E.C.
11UNSAFE COL
11/14/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
11/14/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
11/14/2025FUZHOU DONG ZHI WEI FOODS CO.,LTD

Fujian

CHINAHAW, JUICES OR CONCENTRATES
11UNSAFE COL
11/14/2025Mado Pasticcerie

Bari

ITALYPISTACHIO, PASTE
11UNSAFE COL
11/14/2025Mado Pasticcerie

Bari

ITALYPISTACHIO, SPREAD
11UNSAFE COL
11/14/2025Mado Pasticcerie

Bari

ITALYPISTACHIO, PASTE
11UNSAFE COL
11/14/2025Mado Pasticcerie

Bari

ITALYPISTACHIO, SPREAD
11UNSAFE COL
1...798081...10038

About This Page

This page displays 50 FDA import refusal records from 11 countries. Records on this page involve violations including 118 (NOT LISTED), 75 (UNAPPROVED), 72 (NEW VET DR), 27 (DRUG GMPS), 11 (UNSAFE COL) and 4 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 80 of 10,038 • Showing records 3,951-4,000 of 501,854 total