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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
12/11/2025Brands International Corporation

Newmarket

CANADADIMETHICONE 350 (SURGICAL/PROSTHETIC AID)
118NOT LISTED
3280FRNMFGREG
12/11/2025Fujifilm Corporation

Ashigarakami-Gun

JAPANTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE
118NOT LISTED
341REGISTERED
+1 more
12/11/2025NIPRO INDIA CORPORATION PVT.LTD.

Khandala

INDIADIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
118NOT LISTED
12/11/2025Alcon Research, LTD.

Sinking Spring

UNITED STAUNIT, PHACOFRAGMENTATION
118NOT LISTED
12/11/2025TAMEK GRUP GIDA URETIM A.S.

Bursa

TURKEYTZAHP CHOY (CHINESE CANNED SWEET PICKLES MADE FROM MIXED VEGETABLES) (MIXED VEGETABLES)
83NO PROCESS
12/11/2025ADEFOLORUNSHO TECH ENT

Igbala Sango Ota

NIGERIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
12/11/2025J. C. Udeozor & Sons Global Industries

Benin City

NIGERIAOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
12/11/2025MERZ AESTHETICS

Sao Paulo

BRAZILSYRINGE, ANTISTICK
75UNAPPROVED
12/11/2025MERZ AESTHETICS

Sao Paulo

BRAZILNEEDLE, HYPODERMIC, SINGLE LUMEN
75UNAPPROVED
12/11/2025MERZ AESTHETICS

Sao Paulo

BRAZILWRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
75UNAPPROVED
12/11/2025MERZ AESTHETICS

Sao Paulo

BRAZILWRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
75UNAPPROVED
12/11/2025MERZ AESTHETICS

Sao Paulo

BRAZILWRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
75UNAPPROVED
12/11/2025Novo Nordisk Pharmaceutical

Sao Paulo

BRAZILSEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
12/11/2025B. Braun Melsungen AG

Melsungen

GERMANYMONOCLONAL ANTIBODY, NEC
75UNAPPROVED
12/11/2025Biofarma Natural CMD S.A. de C.V.

Zapopan

MEXICOOXYTETRACYCLINE HYDROCHLORIDE (TETRACYCLINES)
75UNAPPROVED
12/11/2025Biofarma Natural CMD S.A. de C.V.

Zapopan

MEXICOPENICILLIN G, NATURAL
75UNAPPROVED
12/11/2025LUPIN

Duga Lilaka Sikkim

INDIAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
12/11/2025Synokem Pharmaceuticals Ltd

New Delhi

INDIAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
12/11/2025MASCOT HEALTH SERIES PVT LTD

Haridwar

INDIAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
12/11/2025GSK LABORATORY

Guatemala

GUATEMALAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
12/11/2025Amgen, Inc.

Thousand Oaks

UNITED STAANTI-RHEUMATIC N.E.C.
75UNAPPROVED
12/11/2025Merck Frosst Canada, Ltd.

Kirkland

CANADASITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
75UNAPPROVED
12/11/2025Merck Frosst Canada, Ltd.

Kirkland

CANADAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
12/11/2025Bgp Pharma Ulc

Etobicoke

CANADALEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
12/11/2025LUPIN LTD

East Mumbai

INDIARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
12/11/2025Reckitt Benckiser

Mysore

INDIADISINFECTANT N.E.C.
75UNAPPROVED
12/11/2025Reckitt Benckiser

Mysore

INDIADISINFECTANT N.E.C.
75UNAPPROVED
12/11/2025Reckitt Benckiser

Mysore

INDIADISINFECTANT N.E.C.
75UNAPPROVED
12/11/2025Reckitt Benckiser

Mysore

INDIADISINFECTANT N.E.C.
75UNAPPROVED
12/11/2025IDEALSA CALZADA AGUILAR BATRES

Guatemala

GUATEMALABEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
324NO ENGLISH
+1 more
12/11/2025Swizzels Matlow Limited

High Peak

UNITED KINLICORICE CANDY, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
321LACKS N/C
+1 more
12/11/2025Swizzels Matlow Limited

High Peak

UNITED KINLOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
321LACKS N/C
+1 more
12/11/2025Swizzels Matlow Limited

High Peak

UNITED KINLOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
321LACKS N/C
+1 more
12/11/2025Alimentos Maravilla S.A.

Escuintla

GUATEMALAORANGE, CITRUS FRUIT JUICES OR CONCENTRATES
11UNSAFE COL
253STD IDENT
+3 more
12/11/2025PAT SAF

Montreal

CANADABAKLAVA
11UNSAFE COL
218LIST INGRE
+4 more
12/11/2025Yamaharu Co., Ltd.

Koto

JAPANRADISH (ROOT & TUBER VEGETABLE)
11UNSAFE COL
12/11/2025Elim Peche

Joal-Fadiouth

SENEGALSNAILS, AQUATIC, OTHER AQUATIC SPECIES
9SALMONELLA
12/10/2025PT. Indesso Aroma - Plant 1

Banyumas

INDONESIAESSENTIAL OILS FOR FLAVORING, N.E.C.
39103910
12/10/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3851TPLACKFIRM
3854TPLKUSSLLB
12/10/2025CHAINPOP AB

Goteborg

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
12/10/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
12/10/2025HELIX SWEDEN AB

Helsingborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
12/10/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
12/10/2025HELIX SWEDEN AB

Helsingborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
12/10/2025HELIX SWEDEN AB

Helsingborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/10/2025HELIX SWEDEN AB

Helsingborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
12/10/2025Jiangsu Winnie Food Co., Ltd.

Nantong

CHINAMIXED FRUIT FLAVORED IMITATION FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED
3422UNFIT4FOOD
12/10/2025Jiangsu Winnie Food Co., Ltd.

Nantong

CHINAMIXED FRUIT FLAVORED IMITATION FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED
3422UNFIT4FOOD
12/10/2025DASENLIN FOOD CO., LTD

Jilin

CHINAICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)
3421MELAMINE
64YELLOW #5
12/10/2025DASENLIN FOOD CO., LTD

Jilin

CHINAICES, FRUIT FLAVORED, ON A STICK, (POPSICLES, ETC.)
3421MELAMINE

About This Page

This page displays 50 FDA import refusal records from 15 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 341 (REGISTERED), 508 (NO 510(K)), 83 (NO PROCESS) and 18 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 25 of 10,038 • Showing records 1,201-1,250 of 501,854 total