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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
12/1/2025BIOHEAL OTTAWA

Ottawa

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+3 more
12/1/2025GUANGDONG JIAN SU JING BIOTECHNO

Shantou

CHINAMOISTURIZING (SKIN CARE PREPARATIONS)
118NOT LISTED
75UNAPPROVED
12/1/2025Merck, S.A. de C.V.

Naucalpan De Juarez

MEXICODICLOFENAC SODIUM (ANTI-INFLAMMATORY)
118NOT LISTED
75UNAPPROVED
12/1/2025HK YU TING TECHNOLOGY CO

Hong Kong

HONG KONGIVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
118NOT LISTED
72NEW VET DR
+1 more
12/1/2025Ursapharm Arzneimittel GmbH

Saarbrucken

GERMANYANTI-INFLAMMATORY N.E.C.
118NOT LISTED
12/1/2025INTT COSMETICOS

Sao Paulo

BRAZILLUBRICANT, VAGINAL, PATIENT
118NOT LISTED
12/1/2025INTT COSMETICOS

Sao Paulo

BRAZILLUBRICANT, VAGINAL, PATIENT
118NOT LISTED
12/1/2025INTT COSMETICOS

Sao Paulo

BRAZILLUBRICANT, VAGINAL, PATIENT
118NOT LISTED
12/1/2025INTT COSMETICOS

Sao Paulo

BRAZILLUBRICANT, VAGINAL, PATIENT
118NOT LISTED
11/29/2025BAHAUDDIN AL-BASTANJI AND PARTNERS COMPANY

Amman

JORDANSOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
308MFR INSAN
9SALMONELLA
11/29/2025BAHAUDDIN AL-BASTANJI AND PARTNERS COMPANY

Amman

JORDANSOFT CANDY WITH NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
308MFR INSAN
9SALMONELLA
11/29/2025BAHAUDDIN AL-BASTANJI AND PARTNERS COMPANY

Amman

JORDANSOFT CANDY WITH NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
308MFR INSAN
9SALMONELLA
11/29/2025BAHAUDDIN AL-BASTANJI AND PARTNERS COMPANY

Amman

JORDANSESAME SEED PASTE (E.G., TAHINA), EDIBLE SEED PROD.
308MFR INSAN
9SALMONELLA
11/28/2025THAI HARBAL HONGTHAI CO.,LTD.

Bang Khae

THAILANDMENTHOL (ANTI-PRURITIC)
118NOT LISTED
3280FRNMFGREG
+1 more
11/28/2025CBI SRO

Teplice

CZECH REPUHEAT-NOT-BURN CIGARETTES SYSTEMS
3851TPLACKFIRM
3854TPLKUSSLLB
11/28/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3851TPLACKFIRM
3854TPLKUSSLLB
11/28/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3851TPLACKFIRM
3854TPLKUSSLLB
11/28/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3851TPLACKFIRM
3854TPLKUSSLLB
11/28/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3851TPLACKFIRM
3854TPLKUSSLLB
11/28/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3851TPLACKFIRM
3854TPLKUSSLLB
11/28/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3851TPLACKFIRM
3854TPLKUSSLLB
11/28/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3851TPLACKFIRM
3854TPLKUSSLLB
11/28/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3851TPLACKFIRM
3854TPLKUSSLLB
11/28/2025Fiedler & Lundgren Ab

Malmo

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/28/2025LIW INNOVATION AB

Hokerum

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
11/28/2025CHAINPOP AB

Goteborg

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/28/2025BAS NORDIC AB

Malmo

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/28/2025BAS NORDIC AB

Malmo

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/28/2025BAS NORDIC AB

Malmo

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
11/28/2025FIRST MED INSTRUMENTS

Sailkot

PAKISTANHAMMER, SURGICAL
290DE IMP GMP
11/28/2025Response Biomedical Corp.

Vancouver

CANADAGENERAL PURPOSE REAGENT
118NOT LISTED
3280FRNMFGREG
+2 more
11/28/2025DR NANDURI ANIL PRASHANT

Hyderabad

INDIAGLUCOSE OXIDASE, GLUCOSE
118NOT LISTED
3280FRNMFGREG
+1 more
11/28/2025NAOKI IWASE

Minato

JAPANLENS, CONTACT (DISPOSABLE)
118NOT LISTED
3280FRNMFGREG
+2 more
11/28/2025NAOKI IWASE

Minato

JAPANLENS, CONTACT (DISPOSABLE)
118NOT LISTED
3280FRNMFGREG
+2 more
11/28/2025NAOKI IWASE

Minato

JAPANLENS, CONTACT (DISPOSABLE)
118NOT LISTED
3280FRNMFGREG
+2 more
11/28/2025COCOONCENTER

La Veuve

FRANCESODIUM CHLORIDE (REPLENISHER)
118NOT LISTED
3280FRNMFGREG
11/28/2025SERVIER INDIA P LTD

Mumbai

INDIAGLIMEPIRIDE (ANTI-DIABETIC)
118NOT LISTED
3280FRNMFGREG
11/28/2025PURE AND CURE HEALTHCARE

Uttarakhand

INDIAMECOBALAMIN (VITAMIN)
118NOT LISTED
3280FRNMFGREG
11/28/2025ZYDUS CADILLAZYDUS HEALTHCARE LT

Kamaray Bhasmay

INDIAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
118NOT LISTED
3280FRNMFGREG
11/28/2025Sun Pharma Laboratories Ltd

Dist Kamrup

INDIALEVETIRACETAM (ANTI-CONVULSANT)
118NOT LISTED
3280FRNMFGREG
11/28/2025ERIS THERAPEUTICS LTD

Ahmedabad

INDIAMETFORMIN (ANTI-DIABETIC)
118NOT LISTED
3280FRNMFGREG
11/28/2025MANKIND PHARMA LTD DORNING

Sikkim

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
3280FRNMFGREG
11/28/2025SUSV PRIVATE LTD

Mumbai

INDIAASPIRIN (ANALGESIC)
118NOT LISTED
3280FRNMFGREG
11/28/2025CooperVision CL KFT

Gyal

HUNGARYLENS, CONTACT (DISPOSABLE)
118NOT LISTED
508NO 510(K)
11/28/2025DR NANDURI ANIL PRASHANT

Hyderabad

INDIAITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
11/28/2025COCOONCENTER

La Veuve

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
11/28/2025GILEAD SCIENCES CANDA, INC

Mississauga

CANADAEMTRICITABINE
75UNAPPROVED
11/26/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
11/26/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
11/26/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
1...909192...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), 483 (DRUG NAME), 75 (UNAPPROVED), 82 (RX LEGEND) and 11 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 91 of 10,077 • Showing records 4,501-4,550 of 503,850 total