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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
11/1/2025Forever 18 International

Seoul

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
237NO PMA
+1 more
11/1/2025Piramal Pharma Limited

Pithampur

INDIALORATADINE (ANTI-ASTHMATIC)
75UNAPPROVED
11/1/2025SUN PHARMA LABORATIROES

Sikkim

INDIARISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
11/1/2025ABBOTT INDIA LIMITED

Bhiwandi

INDIAFLUVOXAMINE MALEATE (ANTI-DEPRESSANT)
75UNAPPROVED
11/1/2025NATCO PHARMA LIMITED

Hyderabad

INDIATRIFLUMIDATE (ANTI-INFLAMMATORY)
75UNAPPROVED
11/1/2025MERZ THERAPEUTICS

Raleigh

UNITED STAINCOBOTULINUMTOXINA
75UNAPPROVED
11/1/2025Farmaceutica Wandel S.A. de C.V.

Col. Ejidos de Padierna

MEXICOAMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
11/1/2025Farmaceutica Wandel S.A. de C.V.

Col. Ejidos de Padierna

MEXICOAMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
11/1/2025Eli Lilly

Fegersheim

FRANCETIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
10/31/2025HALDIRAM SNACKS PVT LTD

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
3821MFR INJ
10/31/2025HALDIRAM SNACKS PVT LTD

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
3821MFR INJ
10/31/2025HALDIRAM SNACKS PVT LTD

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
3821MFR INJ
10/31/2025HALDIRAM SNACKS PVT LTD

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
3821MFR INJ
10/31/2025HALDIRAM SNACKS PVT LTD

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
3821MFR INJ
10/31/2025HALDIRAM SNACKS PVT LTD

Noida

INDIASNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
308MFR INSAN
3821MFR INJ
10/31/2025HOLLE FOOD

Riehen

SWITZERLANOTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA
260FALSE
488HEALTH C
10/31/2025PLANTAS MEDICINALES DE MEXICO

DELEGACION XOCHIMILCO C.P

MEXICOMULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
256INCONSPICU
324NO ENGLISH
+3 more
10/31/2025PLANTAS MEDICINALES DE MEXICO

DELEGACION XOCHIMILCO C.P

MEXICOMULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
256INCONSPICU
324NO ENGLISH
+3 more
10/31/2025DM-DROGERIE MARKT GMBH + CO. KG

Karlsruhe

GERMANYVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
256INCONSPICU
324NO ENGLISH
+1 more
10/31/2025PAIMING TRADING CO LTD

Huzhou

CHINACHOCOLATE AND CHOCOLATE COVERED CANDY, WITHOUT NUTS AND FRUIT, N.E.C.
251POISONOUS
3421MELAMINE
10/31/2025Amor Nino International Trading Inc

Tarlac

PHILIPPINEANCHOVY
249FILTHY
10/31/2025GREEN MINI MART

Telangana

INDIATAMARIND, DRIED OR PASTE
249FILTHY
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025PT Beiersdorf Indonesia

Malang

INDONESIADEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
218LIST INGRE
2280DIRSEXMPT
+1 more
10/31/2025JOHNSON AND JOHNSON ID MEDICAL DIVISION

Jakarta Selatan

INDONESIAMOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
197COSM COLOR
75UNAPPROVED
10/31/2025PT. Johnson & Johnson Indonesia

Jakarta

INDONESIAMOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
197COSM COLOR
75UNAPPROVED
10/31/2025PT. Johnson & Johnson Indonesia

Jakarta

INDONESIAMOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
197COSM COLOR
75UNAPPROVED
10/31/2025Coopervision, Inc.

Pleasanton

UNITED STALENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
3280FRNMFGREG
+1 more
10/31/2025Johnson & Johnson Vision Care, Inc.

Jacksonville

UNITED STALENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
3280FRNMFGREG
+1 more
10/31/2025ALLERS GROUP

Bogota

COLOMBIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+2 more
10/31/2025Forever 18 International

Seoul

SOUTH KOREMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
10/31/2025Colgate Palmolive

Warsaw

POLANDDENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
118NOT LISTED
3280FRNMFGREG
+1 more
10/31/2025Colgate-Palmolive China

Guangzhou

CHINASTANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
3280FRNMFGREG
10/31/2025Advanced Ambulatory, Inc.

Houston

UNITED STAOXIMETER, TISSUE SATURATION
118NOT LISTED
508NO 510(K)
10/31/2025Aesculap AG

Tuttlingen

GERMANYTAPE, TELEVISION & VIDEO, CLOSED-CIRCUIT, USED DURING ENDOSCOPIC PROCEDURE
118NOT LISTED
341REGISTERED
10/31/2025JOHONSON & JOHNSON MEDICAL

Brampton

CANADALENS, CONTACT (OTHER MATERIAL) - DAILY
118NOT LISTED
341REGISTERED
10/31/2025SPECSAVERS OPTICAL GROUP LIMITED

Guernsey

UNITED KINLENS, CONTACT (DISPOSABLE)
118NOT LISTED
341REGISTERED
10/31/2025Dr. Reddy's Laboratories

Hyderabad

INDIARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
118NOT LISTED
10/31/2025BC LTD C/O PASTURE

Singapore

SINGAPORERIVAROXABAN
75UNAPPROVED
10/31/2025Marico Limited

Sila

INDIAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 15 countries. Records on this page involve violations including 118 (NOT LISTED), 237 (NO PMA), 3280 (FRNMFGREG), 75 (UNAPPROVED), 308 (MFR INSAN) and 17 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 159 of 10,077 • Showing records 7,901-7,950 of 503,850 total