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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/9/2026Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
1/9/2026NOVO NORDISK SERV PROF S A DE CV

Polando

MEXICOLIRAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/9/2026ARMSTRONG LABORATORIOS DE MEXICOS.

Ciudad De Mexico

MEXICOLEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
1/9/2026DRHOMEO PVT LTD

Chandigarh

INDIACALCIUM (MINERAL)
75UNAPPROVED
1/9/2026DRHOMEO PVT LTD

Chandigarh

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/9/2026Medice Arzneimittel Puetter Gmbh

Iserlohn

GERMANYLISDEXAMFETAMINE (STIMULANT)
75UNAPPROVED
1/9/2026Glaxosmithkline

Oslo

NORWAYSUMATRIPTAN SUCCINATE (ANTIMIGRAINE AGENT)
75UNAPPROVED
1/9/2026ORIFARM GENERICS AS

Odense S

DENMARKMETOCLOPRAMIDE (ANTACID)
75UNAPPROVED
1/9/2026Pharmachemie B.V. dba Teva Pharmachemie

Haarlem

NETHERLANDLISDEXAMFETAMINE (STIMULANT)
75UNAPPROVED
1/9/2026H. Lundbeck A/S

Valby

DENMARKAMITRIPTYLINE HCL (ANTI-DEPRESSANT)
75UNAPPROVED
1/9/2026EUROFARMA LABORATORIOS LTDA

Sao Paulo

BRAZILFLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026FARMOQUIMICA

Rio De Janeiro

BRAZILANTIPARASITIC, N.E.C.
75UNAPPROVED
1/9/2026ACHE LABORATORIOS FARMACEUTICOSSA

Sao Paulo

BRAZILMINOXIDIL (ANTI-HYPERTENSIVE)
75UNAPPROVED
1/9/2026ACHE LABORATORIOS FARMACEUTICOSSA

Sao Paulo

BRAZILDUTASTERIDE
75UNAPPROVED
1/9/2026LUPIN LTD

Sikkim

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
1/9/2026Pfizer Canada

Kirkland

CANADAAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
1/9/2026CYNDEA PHARMA S.L.

Soria

SPAINPROGESTERONE (PROGESTIN)
75UNAPPROVED
1/9/2026RB Salute Mexico SA de CV

Coyoacan

MEXICOACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
1/9/2026CIPLA LTD

Ahmedabad

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
1/9/2026GLAXOSMITHKLINE PHARMACEUTICALS

Aurangabad

INDIAHOMEOPATHIC ANTI-INFECTIVE
75UNAPPROVED
1/9/2026SUN PHARMACEUTICAL INDUSTRIES

Gujarant

INDIARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026SUN PHARMACEUTICAL INDUSTRIES

Gujarant

INDIARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026SUN PHARMACEUTICAL INDUSTRIES

Gujarant

INDIARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026SUN PHARMACEUTICAL INDUSTRIES

Gujarant

INDIARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026LABORATORIO FRANCO COLOMBIA

Valle Del Cauca

COLOMBIAFLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026NOVO NORDISK

Whitefield

BULGARIASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/9/2026WENG SENG HENG MEDICAL FACTORY

Pulau Pinang

MALAYSIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/9/2026LIDIA GOMEZ

Guatemala

GUATEMALAVITAMIN, N.E.C.
75UNAPPROVED
1/9/2026LIDIA GOMEZ

Guatemala

GUATEMALAVITAMIN, N.E.C.
75UNAPPROVED
1/9/2026PEACH HERBALS

14440

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/9/2026PEACH HERBALS

14440

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/9/2026SHREE PHARMA

Nagpur

INDIATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
1/9/2026Torrent Pharmaceuticals

Gangtok

INDIACHYMOTRYPSIN (ENZYME)
75UNAPPROVED
1/9/2026LLANTRISANT MANUFACTURING PLT

Pontyclun

UNITED KINLED, GENERAL PURPOSE ILLUMINATION, GENERAL OPTICAL PRODUCTS, NON-MEDICAL
47NON STD
1/9/2026Lufthansa Technik

Hamburg

GERMANYLED, GENERAL PURPOSE ILLUMINATION, GENERAL OPTICAL PRODUCTS, NON-MEDICAL
47NON STD
1/9/2026Kolmar Korea Co. Ltd.

Sejong

SOUTH KOREULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
27DRUG GMPS
1/9/2026Nestle Canada Inc. - Toronto Sterling Rd factory

Toronto

CANADACHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT
11UNSAFE COL
274COLOR LBLG
1/9/2026PRODUCTOS DE LECHE ALDAMA

Guanajuato

MEXICOPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
11UNSAFE COL
274COLOR LBLG
1/9/2026ZENITH DRINKS PVT LTD

New Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
11UNSAFE COL
75UNAPPROVED
1/9/2026ZENITH DRINKS PVT LTD

New Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
11UNSAFE COL
75UNAPPROVED
1/9/2026ZENITH DRINKS PVT LTD

New Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
11UNSAFE COL
75UNAPPROVED
1/9/2026ZENITH DRINKS PVT LTD

New Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
11UNSAFE COL
75UNAPPROVED
1/9/2026ZENITH DRINKS PVT LTD

New Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
11UNSAFE COL
75UNAPPROVED
1/9/2026NESTLE NIGERIA

Ilupeju

NIGERIAMIXED SPICES AND SEASONING WITH SALT, N.E.C.
11UNSAFE COL
1/8/2026ANHUI DONG BAO FOOD CO.,LTD.

Hefei City

CHINACHESTNUT, SHELLED
3600REFUSE EI
3846807REFUSAL
1/8/2026Parkacre Limited

Gainsborough

UNITED KINVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
3560SUPPL GMP
1/8/2026H&J CO., LTD

Dalian

CHINACORN, HOMINY GRITS
3421MELAMINE
1/8/2026Fujian Dongshui Food Co., Ltd.

Fuzhou City

CHINACROAKER
2860VETDRUGRES
1/8/2026NIPRO INDIA CORPORATION PVT.LTD.

Khandala

INDIADIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
2780DEVICEGMPS
1/8/2026PT. VAN AROMA

Bogor

INDONESIAESSENTIAL OILS FOR FLAVORING, N.E.C.
2420RADIONUC
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About This Page

This page displays 50 FDA import refusal records from 18 countries. Records on this page involve violations including 75 (UNAPPROVED), 47 (NON STD), 27 (DRUG GMPS), 11 (UNSAFE COL), 274 (COLOR LBLG) and 7 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 26 of 10,077 • Showing records 1,251-1,300 of 503,850 total