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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
11/25/2025SBL Private Limited

Haridwar

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/25/2025SBL Private Limited

Haridwar

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/25/2025TAKEDA CANADA INC

Toronto

CANADAANTACID, N.E.C.
75UNAPPROVED
11/25/2025LEGRAND PHARMA INDUSTRIA

Hortolandia

BRAZILDL-PHENYLALANINE (PROTEIN)
75UNAPPROVED
11/25/2025CENTRAL FARMA

Ipatinga

BRAZILANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
11/25/2025CENTRAL FARMA

Ipatinga

BRAZILANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
11/25/2025ABBVIE INC

Madison

UNITED STALINACLOTIDE (AGONIST)
75UNAPPROVED
11/25/2025ELI LILLY CANADA

Toronto

CANADATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
11/25/2025ELI LILLY CANADA

Toronto

CANADATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
11/25/2025SWEETGRASS PHARMACY AND COMPOUND

Mt Pleasant

UNITED STATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
11/25/2025HETERO

Bogota

COLOMBIAQUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
11/25/2025Organon Pharma (UK) Ltd.

Cramlington

UNITED KINSITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
75UNAPPROVED
11/25/2025Boehringer Ingelheim S.A.

Bogota

COLOMBIAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
11/25/2025Legrand Sa

Bogota

COLOMBIAROSUVASTATIN CALCIUM
75UNAPPROVED
11/25/2025Merck Colombia Sa

Bogota

COLOMBIALEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
11/25/2025Selectepharma

Mixco

GUATEMALACLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
11/25/2025Laboratorios Farkot, S.A.

Guatemala City

GUATEMALAVITAMIN D2 (CALCIFEROL)
75UNAPPROVED
11/25/2025DRODIFARMA LAB

Guatemala City

GUATEMALAVITAMIN B1 (THIAMINE)
75UNAPPROVED
11/25/2025DRODIFARMA LAB

Guatemala City

GUATEMALANIACIN (NICOTINIC ACID) (VITAMIN)
75UNAPPROVED
11/25/2025Laboratorios Farkot, S.A.

Guatemala City

GUATEMALAVITAMIN K (PHYTONADIONE)
75UNAPPROVED
11/25/2025Verionica Lucia Vasquez Lopez

Ambato

ECUADORSARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
62NEEDS FCE
83NO PROCESS
11/25/2025Verionica Lucia Vasquez Lopez

Ambato

ECUADORSARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
62NEEDS FCE
83NO PROCESS
11/25/2025Sun Pharmaceutical Industries Ltd.

Halol

INDIATOBRAMYCIN (ANTI-MICROBIAL)
27DRUG GMPS
75UNAPPROVED
11/25/2025Sun Pharmaceutical Industries Ltd.

Halol

INDIACARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT
27DRUG GMPS
75UNAPPROVED
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Shandong Binzhou Jonnic Food Co., Ltd

Binzhou

CHINAHAW, DRIED OR PASTE
11UNSAFE COL
274COLOR LBLG
11/25/2025Mado Pasticcerie

Bari

ITALYPISTACHIO, SPREAD
11UNSAFE COL
11/25/2025Mado Pasticcerie

Bari

ITALYPISTACHIO, SPREAD
11UNSAFE COL
11/25/2025Mado Pasticcerie

Bari

ITALYPISTACHIO, SPREAD
11UNSAFE COL
11/25/2025Mado Pasticcerie

Bari

ITALYPISTACHIO, SPREAD
11UNSAFE COL
11/25/2025GALLANT OCEAN INTERNATIONAL, INC. XIAOGANG PLANT

KAOHSIUNG

TAIWANBARRAMUNDI
9SALMONELLA
11/25/2025Tongwei Hainan Aquatic Products Co., Ltd.

Chengmai County

CHINATILAPIA, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS
9SALMONELLA
11/25/2025Saidowla (Pvt.)Enterprise Limited

Choukide Khi

BANGLADESHFISH, N.E.C.
9SALMONELLA
11/25/2025Saidowla (Pvt.)Enterprise Limited

Choukide Khi

BANGLADESHFISH, N.E.C.
9SALMONELLA
11/25/2025Forest Foods Co., Ltd.

Jilin

CHINAICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)
3421MELAMINE
11/25/2025Forest Foods Co., Ltd.

Jilin

CHINAICE CREAM AND RELATED PRODUCTS, N.E.C.
3421MELAMINE
11/25/2025Forest Foods Co., Ltd.

Jilin

CHINAICE CREAM AND RELATED PRODUCTS, N.E.C.
3421MELAMINE
11/25/2025NGP TOBACCO

Aalborg Sv

DENMARKNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
11/25/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
11/25/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
1...949596...10077

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 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 95 of 10,077 • Showing records 4,701-4,750 of 503,850 total