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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
11/10/2025ELI LILLY CANADA INC

Toronto

CANADATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
11/10/2025SANDOZ CANADA INC

Boucherville

CANADAESTRADIOL (ESTROGEN)
75UNAPPROVED
11/10/2025HELIX BIOPHARMA CORP

Toronto

CANADAANTI-ECZEMATIC N.E.C.
75UNAPPROVED
11/10/2025HAYAT PHARMACEUTICAL IND

Amman

JORDANCLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)
75UNAPPROVED
11/10/2025BGP PHARMA ULC

Halifax

CANADAPANCRELIPASE
75UNAPPROVED
11/10/2025Merz Pharmaceuticals GmbH

Frankfurt Am Main

GERMANYOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/10/2025Merz North America, Inc.

Franksville

UNITED STAOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/10/2025Takeda Canada

Oakville

CANADAVEDOLIZUMAB
75UNAPPROVED
11/10/2025Pfizer Ltd.

Mumbai

INDIAMEFENAMIC ACID (ANTI-INFLAMMATORY)
75UNAPPROVED
11/10/2025Pfizer Ltd.

Mumbai

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
11/10/2025SUN PHARMA LABORATORIES LTD

Karnruo

INDIALEVETIRACETAM (ANTI-CONVULSANT)
75UNAPPROVED
11/10/2025Auro Pharma Inc.

Woodbridge

CANADATADALAFIL
75UNAPPROVED
11/10/2025IBTJ CO LTD

Osaka

JAPANEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
11/10/2025GSK LABORATORIES

Guatemala

GUATEMALAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
11/10/2025OMEGA NUTRITION

Hidalgo Del Parral

MEXICOVITAMIN, N.E.C.
75UNAPPROVED
11/10/2025NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
11/10/2025REYOUNG PHARCEUTICAL CO LTD

San Pedro

HONDURASAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
11/10/2025REYOUNG PHARCEUTICAL CO LTD

San Pedro

HONDURASIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
11/10/2025Ursapharm Arzneimittel GmbH

Saarbrucken

GERMANYDEXPANTHENOL (CHOLINERGIC)
75UNAPPROVED
11/10/2025PHARA SA

Quetzaltenango

GUATEMALAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
75UNAPPROVED
11/10/2025LOPEZ LABORATORY

Zona 10

GUATEMALAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
75UNAPPROVED
11/10/2025LABORATORY PROMISE

Guatemala

GUATEMALAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
75UNAPPROVED
11/10/2025MMG HEALTHCARE

Pradesh

INDIACARBOXYMETHYLCELLULOSE SODIUM, EMOLLIENT,LUBRICANT
75UNAPPROVED
11/10/2025QUINFICA LABORATORY

Guatemala

GUATEMALAVITAMIN B12 (CYANOCOBALAMIN)
75UNAPPROVED
11/10/2025CNF CO., LTD.

Gunpo

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/10/2025Seoul Cosmetics Co., Ltd.

Namdong District

SOUTH KOREOTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KORECLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025Ursapharm Arzneimittel GmbH

Saarbrucken

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/10/2025Viatris, Inc.

Canonsburg

UNITED STALEVONORGESTREL (ESTROGEN)
75UNAPPROVED
11/10/2025ADIUVO

Tegucigalpa

HONDURASANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
11/10/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICOVITAMIN, N.E.C.
75UNAPPROVED
11/10/2025SANOFI MEDLEY

Suzano

BRAZILDIPYRONE (ANALGESIC)
75UNAPPROVED
11/10/2025ADIUVO COLONIA

Tegucigalpa

HONDURASDEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD)
75UNAPPROVED
11/10/2025PHARMA

Tegucigalpa

HONDURASAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
11/10/2025CAPLIN POINT LABORATORIES LTD

Chennai

INDIAIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
11/10/2025Seoul Cosmetics Co., Ltd.

Namdong District

SOUTH KORETONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREMOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025Dr. Babor GmbH & Co. KG

Aachen

GERMANYULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
11/10/2025AJANTA PHARMA LIMITED

Dehradun

INDIASHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
11/10/2025MONICHEM HEALTHCARE PVT LTD

Nagar

INDIABATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KORECLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025A.S.P. Internation Herbal Soap Co.,Ltd.]

Bang Bua Thong

THAILANDBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
11/10/2025UNFOLDED CIRCLE APS

Frederiksberg

DENMARKREMOTE CONTROLLER, LASER, DATA MEASUREMENT, TRANSMIT
47NON STD
11/10/2025UNFOLDED CIRCLE APS

Frederiksberg

DENMARKREMOTE CONTROLLER, LASER, DATA MEASUREMENT, TRANSMIT
47NON STD
11/10/2025Universal Laser Systems Co Ltd.

Yokohama-shi

JAPANGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
11/10/2025DALIAN YOUOPTO TECHNOLOGY CO LTD

Dalian

CHINAGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
11/10/2025Intas Pharmaceuticals Limited

Ahmedabad

INDIAEMOLLIENT, LUBRICANT, N.E.C.
27DRUG GMPS
11/10/2025Kolmar Korea Co. Ltd.

Sejong

SOUTH KOREULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
27DRUG GMPS
11/10/2025Swizzels Matlow Limited

High Peak

UNITED KINJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
11/10/2025Swizzels Matlow Limited

High Peak

UNITED KINJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
1...959697...10038

About This Page

This page displays 50 FDA import refusal records from 15 countries. Records on this page involve violations including 75 (UNAPPROVED), 47 (NON STD), 27 (DRUG GMPS), 11 (UNSAFE COL). Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 96 of 10,038 • Showing records 4,751-4,800 of 501,854 total