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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
3/21/2025Nutri-Asia

Bulacan

PHILIPPINEBARBECUE SAUCE
238UNSAFE ADD
3/21/2025Nutri-Asia

Bulacan

PHILIPPINEBARBECUE SAUCE
238UNSAFE ADD
3/21/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
238UNSAFE ADD
3/21/2025Nutri-Asia, Incorporated dba UFC Philippines

Laguna

PHILIPPINEBANANA SAUCE
238UNSAFE ADD
3/21/2025Daqing Ruby Ice Cream Co., Ltd.

Daqing

CHINAICE CREAM BARS
218LIST INGRE
324NO ENGLISH
+3 more
3/21/2025FUJIAN LONGWANG FOOD&BEVERAGE CO.,LTD

Fuzhou

CHINAICE CREAM BARS
218LIST INGRE
324NO ENGLISH
+3 more
3/21/2025Daqing Ruby Ice Cream Co., Ltd.

Daqing

CHINAICE CREAM BARS
218LIST INGRE
324NO ENGLISH
+2 more
3/21/2025FUJIAN LONGWANG FOOD&BEVERAGE CO.,LTD

Fuzhou

CHINAICE CREAM BARS
218LIST INGRE
324NO ENGLISH
+2 more
3/21/2025FUJIAN LONGWANG FOOD&BEVERAGE CO.,LTD

Fuzhou

CHINAICE CREAM BARS
218LIST INGRE
324NO ENGLISH
+2 more
3/21/2025Jiangmen Xinhui Shuangying Sugar Co., Ltd

Jiang Men

CHINASALTED CRACKERS
218LIST INGRE
256INCONSPICU
+3 more
3/21/2025Jiangmen Xinhui Shuangying Sugar Co., Ltd

Jiang Men

CHINASALTED CRACKERS
218LIST INGRE
256INCONSPICU
+2 more
3/21/2025SILVERFILDENTAL PRODUCTS

Petaling

MALAYSIAALLOY, AMALGAM
118NOT LISTED
3280FRNMFGREG
+2 more
3/21/2025SILVERFILDENTAL PRODUCTS

Petaling

MALAYSIAALLOY, AMALGAM
118NOT LISTED
3280FRNMFGREG
+2 more
3/21/2025Dollar Company Pvt Ltd

Tamil Nadu

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
3/21/2025SUNSTAR IBERIA

Barcelona

SPAINSODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
3280FRNMFGREG
3/21/2025SUNSTAR IBERIA

Barcelona

SPAINSODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
3280FRNMFGREG
3/21/2025BIGAMART

Ayr

UNITED KINRELINER, DENTURE, OTC
118NOT LISTED
3280FRNMFGREG
3/21/2025TYROMONT ALPIN TECHNIK

Thaur

AUSTRIABED, MANUAL
118NOT LISTED
3280FRNMFGREG
3/21/2025TYROMONT ALPIN TECHNIK

Thaur

AUSTRIABED, MANUAL
118NOT LISTED
3280FRNMFGREG
3/21/2025SINOTRANS AIR FREIGHT CO NB

Ningbo

CHINADRESSING, WOUND, DRUG
118NOT LISTED
3280FRNMFGREG
3/21/2025SUN PHARMA LABORATORIES LTD

Assam

INDIAAMANTADINE HCL (ANTI-VIRAL)
118NOT LISTED
75UNAPPROVED
3/21/2025TECNOQUIMICAS DOMINICANA AV.

Santo Domingo

DOMINICAN CLOPIDOGREL BISULFATE (ANTI-COAGULANT)
118NOT LISTED
75UNAPPROVED
3/21/2025GEFARCA INDUSRIAL FARMACEUTICA

Santo Domingo De Guzman

DOMINICAN CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
75UNAPPROVED
3/21/2025Novartis Argentina

Buenos Aires

ARGENTINAMETFORMIN HCL (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
3/21/2025Ursapharm Arzneimittel GmbH

Saarbrucken

GERMANYSOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE
118NOT LISTED
3/21/2025Shan Foods (Private) Limited

Karachi

PAKISTANMANGO (SUBTROPICAL AND TROPICAL FRUIT)
83NO PROCESS
3/21/2025BERTHA OSPINA

Bogota

COLOMBIACARVEDILOL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
3/21/2025LABORATORIOS RAFFO INT CEL

Aires

ARGENTINAEZETIMIBE
75UNAPPROVED
3/21/2025BOEHRINGER INGELHEIM PROMECO S.A. de C.V.

Ciudad De Mexico

MEXICOLINAGLIPTIN (ANTI-DIABETIC)
75UNAPPROVED
3/21/2025LABORATORIOS LIEMONT

Cuajimalpa de Marelos

MEXICOPIOGLITAZONE HCL
75UNAPPROVED
3/21/2025LABORATORIOS SALFARN SA ALTOS HO

Jalisco

MEXICOOMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
3/21/2025Sanofi-Aventis De Mexico

Ocoyoacac

MEXICOACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
3/21/2025MERC

Naucalpan De Juarez

MEXICOLEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
3/21/2025SRI RAMA HEALTH CARE PVT LTD

Solan

INDIANEOMYCIN (AMINOGLYCOSIDES)
75UNAPPROVED
3/21/2025RAJIV SHVSHANKAR THAKAR

Gandhinagar

INDIAFLUTICASONE PROPIONATE (BRONCHODILATOR)
75UNAPPROVED
3/21/2025Cpla Ltd

Goa

INDIACIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
3/21/2025MSN Laboratories Private Limited (Formulations Division, Unit-II)

Rangareddy District

INDIAEPLERENONE
75UNAPPROVED
3/21/2025Cpla Ltd

Goa

INDIATORSEMIDE (DIURETIC)
75UNAPPROVED
3/21/2025Microlabs Ltd

Sikkim

INDIABISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
3/21/2025Cpla Ltd

Goa

INDIAAMIODARONE HYDROCHLORIDE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC))
75UNAPPROVED
3/21/2025AJANTA PHARMA LTD

Kamrup Assam

INDIADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
3/21/2025UNISON PHARMACUETICALS PVT LTD

Ahmedabad

INDIARABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER)
75UNAPPROVED
3/21/2025Torrent Pharmaceuticals

Gangtok

INDIAPRASUGREL HYDROCHLORIDE (ANTI-COAGULANT)
75UNAPPROVED
3/21/2025UNISON PHARMACUETICALS PVT LTD

Ahmedabad

INDIAVALSARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
3/21/2025INTAS PHARMACEUTICALS LTD

South Sikkim

INDIAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
3/21/2025RAJIV SHVSHANKAR THAKAR

Gandhinagar

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
3/21/2025ELI LILLY AND COMPANY LIMITED

Twickenham

UNITED KINTIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
3/21/2025ELI LILLY AND COMPANY LIMITED

Twickenham

UNITED KINTIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
3/21/2025ELI LILLY AND COMPANY LIMITED

Twickenham

UNITED KINTIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
3/21/2025THE HIMALAYA WELLNESS LTD

Industrial Area Banga

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 13 countries. Records on this page involve violations including 238 (UNSAFE ADD), 218 (LIST INGRE), 324 (NO ENGLISH), 328 (USUAL NAME), 3300 (ALLERGEN) and 10 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 624 of 10,077 • Showing records 31,151-31,200 of 503,850 total