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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
12/19/2025MSN Laboratories Private Limited

Hyderabad

INDIAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
12/19/2025AstraZeneca Pharmaceuticals LP

Mount Vernon

UNITED STADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
12/19/2025NOVARTIS PHARMACEUTICALS CANADA

Montreal

CANADAIMMUNOLOGICAL AGENT, NEC
75UNAPPROVED
12/19/2025Marcan Pharmaceuticals

Nepean

CANADADOMPERIDONE
75UNAPPROVED
12/19/2025Boehringer Ingelheim Canada

Burlington

CANADAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
12/19/2025Janssen Inc.

North York

CANADABUPROPION HCL (ANTI-DEPRESSANT)
75UNAPPROVED
12/19/2025Janssen Inc.

North York

CANADABUPROPION HCL (ANTI-DEPRESSANT)
75UNAPPROVED
12/19/2025Janssen Inc.

North York

CANADAPRUCALOPRIDE SUCCINATE (CATHARTIC)
75UNAPPROVED
12/19/2025NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
12/19/2025ELI LILLY CANADA

Toronto

CANADAINSULIN GLARGINE
75UNAPPROVED
12/19/2025SANDOZ CANADA INCORPORATED

Saint-Hubert

CANADADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
12/19/2025NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
12/19/2025ELI LILLY CANADA

Toronto

CANADATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
12/19/2025Laboratoire du-Var Inc.

Boucherville

CANADAANALGESIC, N.E.C.
75UNAPPROVED
12/19/2025NATURETEQ INC/ MEDISTIK INC.

North York

CANADAANALGESIC, N.E.C.
75UNAPPROVED
12/19/2025MATIAS HEALTHCARE PVT LTD

Ahmedabad

INDIAFLUOXETINE (ANTI-DEPRESSANT)
27DRUG GMPS
12/19/2025Intas Pharmaceuticals Limited

Gangtok

INDIAARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
27DRUG GMPS
12/19/2025Kolmar Korea Co. Ltd.

Sejong

SOUTH KOREULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
27DRUG GMPS
12/19/2025M/S Jagsonpal Exports India Pvt. Ltd.

Delhi

INDIALEVONORGESTREL (ESTROGEN)
27DRUG GMPS
12/19/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
+1 more
12/19/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/19/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/19/2025THE ALLAN CANDY COMPANY LIMITED

Mississauga

CANADACANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
12/19/2025Navarro'S Company Sa De Cv

Guadalajara

MEXICOIMITATION SYRUPS, MOLASSES AND HONEY, N.E.C.
11UNSAFE COL
274COLOR LBLG
12/19/2025Mars Chocolate UK

Slough

UNITED KINCHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT
11UNSAFE COL
12/19/2025YA-RABI & FRERES

Lome

TOGOSESAME SEED (EDIBLE SEED)
9SALMONELLA
12/19/2025Forest Foods Co., Ltd.

Jilin

CHINAICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)
274COLOR LBLG
12/19/2025Forest Foods Co., Ltd.

Jilin

CHINAICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)
274COLOR LBLG
12/19/2025Forest Foods Co., Ltd.

Jilin

CHINAICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)
274COLOR LBLG
12/19/2025Thaitheparos Public Company Limited

Amphur Muang

THAILANDSOY SAUCE
3886FSVP VIO
12/19/2025Swedish Match North Europe

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
12/19/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
12/19/2025XQS INTERNATIONAL AB

Borlange

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
12/19/2025Swedish Match North Europe

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
12/19/2025CHAINPOP AB

Goteborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
12/19/2025CHAINPOP AB

Goteborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
12/19/2025CHAINPOP AB

Goteborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
12/19/2025HELIX SWEDEN AB

Helsingborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
12/19/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/19/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
12/19/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
12/19/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/19/2025HABIT FACTORY IN SWEDEN AB

Arsta

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/19/2025ANOTHER SNUS FACTORY STOCKHOLM AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/19/2025ANOTHER SNUS FACTORY STOCKHOLM AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/19/2025ANOTHER SNUS FACTORY STOCKHOLM AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/19/2025HELIX SWEDEN AB

Helsingborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/19/2025HELIX SWEDEN AB

Helsingborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/19/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/19/2025CHAINPOP AB

Goteborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA

About This Page

This page displays 50 FDA import refusal records from 10 countries. Records on this page involve violations including 75 (UNAPPROVED), 27 (DRUG GMPS), 11 (UNSAFE COL), 274 (COLOR LBLG), 482 (NUTRIT LBL) and 5 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 48 of 10,077 • Showing records 2,351-2,400 of 503,850 total