ImportRefusal LogoImportRefusal

Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
10/1/2025ASCENDIS PHARMA

Johannesburg

SOUTH AFRIOLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II
118NOT LISTED
3280FRNMFGREG
10/1/2025CL DE PEAU BEAUT JAPAN

Chuo

JAPANLENS, CONTACT (OTHER MATERIAL) - DAILY
118NOT LISTED
3280FRNMFGREG
10/1/2025PATANJALI AYURVED LIMITED

Haridwar

INDIASHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
10/1/2025PATANJALI AYURVED LIMITED

Haridwar

INDIASHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
10/1/2025Reckitt Benckiser

Uttarakhand

INDIABATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/1/2025PEXVARGT S.A.

Guatemala City

GUATEMALAFRUIT BEVERAGE BASE, N.E.C.
11UNSAFE COL
482NUTRIT LBL
10/1/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/1/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/1/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/1/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
10/1/2025GURUJI PRODUCTS PVT. LTD.

Indore

INDIASYRUPS AND MOLASSES, N.E.C.
11UNSAFE COL
10/1/2025DI SANO S.R.L.

City Of Landriano

ITALYNUT, TOPPING, N.E.C.
11UNSAFE COL
10/1/2025AAKASH GLOBAL FOODS PVT.LTD.

Bardari

INDIAFRIED SNACK FOODS, N.E.C.
9SALMONELLA
10/1/2025Fujian Fuzhou Tian Shan Foods Co., Ltd

Fuzhou

CHINAFUNGUS, BLACK (CLOUD EARS), WHOLE (BUTTON) (FUNGI)
9SALMONELLA
10/1/2025Fujian Fuzhou Tian Shan Foods Co., Ltd

Fuzhou

CHINAFUNGUS, BLACK (CLOUD EARS), WHOLE (BUTTON) (FUNGI)
9SALMONELLA
9/30/2025BEIJING SPIRITLASER SCIENCE & TECHNOLOGY CO., LTD.

Shunyi

CHINASTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING
118NOT LISTED
3280FRNMFGREG
+1 more
9/30/2025Teleflex Medical Sdn. Bhd.

Kamunting

MALAYSIACATHETER, RETENTION TYPE, BALLOON
118NOT LISTED
3280FRNMFGREG
9/30/2025Stunmedical Co Ltd

Seongdong District

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
3280FRNMFGREG
9/30/2025Healthcare 4 All

Leeds

UNITED KINSOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE
118NOT LISTED
3280FRNMFGREG
9/30/2025FABINJECT INDUSTRIA E COMERCIO IMPORTACAO E EXPORTACAO LTDA

Taubate

BRAZILNEEDLE, HYPODERMIC, SINGLE LUMEN
118NOT LISTED
3260NO ENGLISH
9/30/2025Farmace - Industria Quimico-Farmaceutica Cearense Ltda.

Barbalha

BRAZILSYRINGE, PISTON, REPROCESSED
118NOT LISTED
3260NO ENGLISH
9/30/2025Dr. Korman Laboratories Ltd

Kiryat Bialik

ISRAELIMPLANT, DERMAL, FOR AESTHETIC USE IN THE HANDS
118NOT LISTED
3260NO ENGLISH
9/30/2025DERMALINE CO LTD

Gyeonggi-Do

SOUTH KOREIMPLANT, DERMAL, FOR AESTHETIC USE IN THE HANDS
118NOT LISTED
3260NO ENGLISH
9/30/2025JIANGSU JICHUN MEDICAL DEVICES CO., LTD.

Changzhou

CHINACATHETER, INTRAVASCULAR, SHORT TERM
118NOT LISTED
3260NO ENGLISH
9/30/2025biometil laboratorio

Sao Bento Do Sul

BRAZILMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
472NO ENGLISH
9/30/2025Farmace - Industria Quimico-Farmaceutica Cearense Ltda.

Barbalha

BRAZILSODIUM CHLORIDE (REPLENISHER)
118NOT LISTED
472NO ENGLISH
9/30/2025CANHAIDOM TRADING

Port Au Pprince

HAITIANALGESIC, N.E.C.
118NOT LISTED
75UNAPPROVED
9/30/2025CANHAIDOM TRADING

Port Au Pprince

HAITIANALGESIC, N.E.C.
118NOT LISTED
75UNAPPROVED
9/30/2025NICOPODS EHF

Sudurnesjabar

ICELANDNICOTINE POUCH
75UNAPPROVED
9/30/2025NICOPODS EHF

Sudurnesjabar

ICELANDNICOTINE DELIVERY PRODUCT, NEC
75UNAPPROVED
9/30/2025Hindustan Unilever Ltd

Assam

INDIAFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
9/30/2025Hindustan Unilever Ltd

Assam

INDIAFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
9/30/2025Reckitt Benckiser

Mysore

INDIADISINFECTANT N.E.C.
75UNAPPROVED
9/30/2025Reckitt Benckiser

Mysore

INDIADISINFECTANT N.E.C.
75UNAPPROVED
9/30/2025Reckitt Benckiser

Mysore

INDIADISINFECTANT N.E.C.
75UNAPPROVED
9/30/2025LAKME LEVER PVT LTD

GUJARAT

INDIABATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
9/30/2025UJALA HOUSE

Mumbai

INDIADENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
9/30/2025Dabur India Limited

Garaimari

INDIADENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
9/30/2025Dabur India Limited

Garaimari

INDIADENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
9/30/2025Dabur India Limited

Garaimari

INDIADENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
9/30/2025Dabur India Limited

Garaimari

INDIADENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
75UNAPPROVED
9/30/2025southern drugs pharmaceuticals

andhra pradesh

INDIAANTACID, N.E.C.
75UNAPPROVED
9/30/2025southern drugs pharmaceuticals

andhra pradesh

INDIAANTACID, N.E.C.
75UNAPPROVED
9/30/2025southern drugs pharmaceuticals

andhra pradesh

INDIAANTACID, N.E.C.
75UNAPPROVED
9/30/2025Hamdard Laboratories

Ghazibad

INDIAOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
9/30/2025Hamdard Laboratories

Ghazibad

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
9/30/2025Dabur India

Jammu

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
9/30/2025Dabur India

Solan

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
9/30/2025Hemani International

Karachi

PAKISTANFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
9/30/2025Abnoba GmbH

Pforzheim

GERMANYMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1...232233234...10077

About This Page

This page displays 50 FDA import refusal records from 16 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 75 (UNAPPROVED), 11 (UNSAFE COL), 482 (NUTRIT LBL) and 5 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 233 of 10,077 • Showing records 11,601-11,650 of 503,850 total