ImportRefusal LogoImportRefusal

Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
11/12/20253M Espe Dental Products

Saint Paul

UNITED STAMATERIAL, TOOTH SHADE, RESIN
118NOT LISTED
3280FRNMFGREG
11/12/20253M Espe Dental Products

Saint Paul

UNITED STAAGENT, TOOTH BONDING, RESIN
118NOT LISTED
3280FRNMFGREG
11/12/20253M Espe Dental Products

Saint Paul

UNITED STACEMENT, DENTAL
118NOT LISTED
3280FRNMFGREG
11/12/20253M Espe Dental Products

Saint Paul

UNITED STASEALANT, PIT AND FISSURE, AND CONDITIONER
118NOT LISTED
3280FRNMFGREG
11/12/2025ALTRUAN GMBH

Massing

GERMANYRESEARCH USE ONLY/MICROBIOLOGY
118NOT LISTED
3280FRNMFGREG
11/12/2025CGBIO CO

Gyeonggi-Do

SOUTH KOREFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
118NOT LISTED
3260NO ENGLISH
+2 more
11/12/2025Unicharm Corp

Higashishirakawa-gun

JAPANTAMPON, MENSTRUAL, UNSCENTED
118NOT LISTED
341REGISTERED
11/12/2025HOA NAM PHARMA

Ha Noi

VIETNAMMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
333LACKS FIRM
+2 more
11/12/2025ALLERGAN

Annecy

FRANCEOTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
237NO PMA
+2 more
11/12/2025Caregen Co., Ltd.

Gunpo

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
237NO PMA
+2 more
11/12/2025H. Lundbeck A/S

Valby

DENMARKESCITALOPRAM OXALATE
118NOT LISTED
11/12/2025Dom Duarte - Industria de Productos Alimentares, Lda

Maia

PORTUGALBARBECUE SAUCE
83NO PROCESS
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STALANSOPRAZOLE (ANTI-SECRETORY)
75UNAPPROVED
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STADULOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STARIVAROXABAN
75UNAPPROVED
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STALOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STAPREGABALIN (ANTI-CONVULSANT)
75UNAPPROVED
11/12/2025TAGI Pharma, Inc.

South Beloit

UNITED STACHLORTHALIDONE (DIURETIC)
75UNAPPROVED
11/12/2025SUN PHARMACEUTICAL (BANGLADESH)

Dhaka

BANGLADESHQUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
11/12/2025HEALING PHARMA INDIA PRIVATE

Mumbai

INDIAIVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
75UNAPPROVED
11/12/2025HEALING PHARMA INDIA PRIVATE

Mumbai

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
11/12/2025Yung Kien Industrial Corporation

Tainan

TAIWANVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
11/12/2025Yung Kien Industrial Corporation

Tainan

TAIWANVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
11/12/2025TRUE PHRMA

Pondicherry

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/12/2025Dr Reckeweg

New Delhi

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/12/2025SSB HOMEOVITALITY INDIA CO

Ap

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/12/2025Dr. Willmar Schwabe India Pvt. Ltd.

Sikandrabad

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/12/2025Dr. Willmar Schwabe India Pvt. Ltd.

Sikandrabad

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/12/2025Dr. Willmar Schwabe India Pvt. Ltd.

Sikandrabad

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/12/2025Sbl Pvt

Delhi

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/12/2025Dr. Willmar Schwabe India Pvt. Ltd.

Sikandrabad

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/12/2025Dr. Willmar Schwabe India Pvt. Ltd.

Sikandrabad

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/12/2025Dr. Willmar Schwabe India Pvt. Ltd.

Sikandrabad

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/12/2025DROGUERIA DERMATOLOGICA DE MEXIC

Coahuila

MEXICOMINOXIDIL (ANTI-HYPERTENSIVE)
75UNAPPROVED
11/12/2025SBL PVT LIMITED

East Sikkim

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/12/2025PURVANSHI INTERNAT

Nagpur

INDIASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
11/12/2025PURVANSHI INTERNAT

Nagpur

INDIASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
11/12/2025ARCHEESH HEALTHCARE

Telengana

INDIAANTI-INFECTIVE, TOPICAL N.E.C.
75UNAPPROVED
11/12/2025NEPTUNE LIFE SCIENCES PVT LTD

Thana Baddi

INDIAMUPIROCIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)
75UNAPPROVED
11/12/2025Olcare Laboratories

Dist. Surendrasagar

INDIALOVASTATIN (ANTI-CHOLESTEREMIC)
75UNAPPROVED
11/12/2025SYNOKEM PHARMACEUTICALS LTD

UTTARAKHAND

INDIAMINOCYCLINE (TETRACYCLINES)
75UNAPPROVED
11/12/2025Sun Pharmaceutical Industries

Mumbai

INDIAULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
11/12/2025REGIUM PHARMACEUTICALS OPC PVT L

New Delhi

INDIASALICYLIC ACID (KERATOLYTIC)
75UNAPPROVED
11/12/2025MALIK LIFESCIENCE PVT. LTD

UTTARAKHAND

INDIACEFPODOXIME PROXETIL (CEPHALOSPORINS)
75UNAPPROVED
11/12/2025MULTI CARGO INC

Doral

UNITED STACLINDAMYCIN PHOSPHATE (LINCOMYCINS)
75UNAPPROVED
11/12/2025QUINFICA LABORATORY

Guatemala

GUATEMALAVITAMIN B12 (CYANOCOBALAMIN)
75UNAPPROVED
11/12/2025AYURVEDA PVT LTD

Delhi

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
11/12/2025NEIMETH INT'L PHARMACEUTICAL

Lagos

NIGERIAPRAZIQUANTEL/PYRANTEL PAMOATE COMBINATION (ANTIPARASITIC)
75UNAPPROVED
11/12/2025BIOLAB SANUS FARMACEUTICA LTDA

S O Paulo

BRAZILVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
11/12/2025Om Pharma

Meyrin

SWITZERLANANTI-BACTERIAL, N.E.C.
75UNAPPROVED

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), 3260 (NO ENGLISH), 75 (UNAPPROVED), 341 (REGISTERED) and 4 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 130 of 10,077 • Showing records 6,451-6,500 of 503,850 total