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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/21/2026BELLROS TRADING LTD N0372787B

Argentona

SPAINIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
3280FRNMFGREG
+1 more
1/21/2026SCHAAN HEALTHCARE PRODUCTS

Saskatoon

CANADADIAPHRAGM, CONTRACEPTIVE (AND ACCESSORIES)
118NOT LISTED
3280FRNMFGREG
+1 more
1/21/2026COOPERVISION DO BRASIL LTDA

Sao Paulo

BRAZILLENSES, SOFT CONTACT, DAILY WEAR
118NOT LISTED
3280FRNMFGREG
+1 more
1/21/2026CREGANNA MEDICALSR

Edificio

COSTA RICAACCESSORIES, CATHETER, G-U
118NOT LISTED
3280FRNMFGREG
+2 more
1/21/2026BUTTERFLY NETWORK

Burlington

UNITED STASYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
118NOT LISTED
3280FRNMFGREG
+2 more
1/21/2026H DHARI SHAH PHARMACY

Ambala Cantt

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
3280FRNMFGREG
+1 more
1/21/2026Beiersdorf Thailand Co Ltd

Bangkok

THAILANDASTRINGENT/ANTI-PERSPIRANT N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
1/21/2026Beiersdorf Thailand Co Ltd

Bangkok

THAILANDASTRINGENT/ANTI-PERSPIRANT N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
1/21/2026DRW SKINCARE

Jakarta Barat

INDONESIAPROTECTANT N.E.C.
118NOT LISTED
3280FRNMFGREG
1/21/2026IP ROSHAL SVETLANA EVGENEVNA

St Petersburg

RUSSIADIETARY CONVENTIONAL FOODS, N.E.C.
118NOT LISTED
3260NO ENGLISH
+2 more
1/21/2026AERIM JUNG

Seoul

SOUTH KOREMOISTURIZING (SKIN CARE PREPARATIONS)
118NOT LISTED
3260NO ENGLISH
+2 more
1/21/2026Baxter Productos Medicos, Ltda.

Cartago

COSTA RICACATHETER ACCESS COVER, TAMPER-RESISTANT
118NOT LISTED
508NO 510(K)
1/21/2026GLOBAL-E C/O SWATI COSMETICS

Skurup

SWEDENLENS, CONTACT (OTHER MATERIAL) - DAILY
118NOT LISTED
237NO PMA
+2 more
1/21/2026VASYL KUTS

Azeitao

PORTUGALIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
1/21/2026METHODOLOGY

Seoul

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
1/21/2026AbbVie Inc.

North Chicago

UNITED STAIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
1/21/2026Across Co., Ltd

Chuncheon-si

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
1/21/2026YOU DRUG MART

Winnipeg

CANADASEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
1/21/2026GALDERMA WT MORUMBI

Sao Paulo

BRAZILONABOTULINUMTOXINA
118NOT LISTED
75UNAPPROVED
1/21/2026Altea Farmaceutica

Bogota

COLOMBIAALLANTOIN (PROTECTANT)
118NOT LISTED
75UNAPPROVED
1/21/2026TERAMED SA DE CV

Merliot

EL SALVADOFLUNARIZINE HCL (VASODILATOR)
118NOT LISTED
75UNAPPROVED
1/21/2026Dr Gustav Klein Gmbh & Co

Zell am Harmersbach

GERMANYHOMEOPATHIC N.E.C.
118NOT LISTED
75UNAPPROVED
1/21/2026XINJIANG NUZILINE BIO-PHARMACEUT

Yili

CHINACONJUGATED ESTROGENS (ESTROGEN)
118NOT LISTED
75UNAPPROVED
1/21/2026MED PHARMA LABORATORY

Guatemala

GUATEMALAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
1/21/2026Reckitt Benckiser

Bangkok

THAILANDIODINATED GLYCEROL (EXPECTORANT)
118NOT LISTED
75UNAPPROVED
1/21/2026LABORATORIOS SUIZOS S.A. DE C.V.

Antiguo Cuscatlan

EL SALVADOVITAMIN, N.E.C.
118NOT LISTED
75UNAPPROVED
1/21/2026LABORATORIOS VIJOSA

Santa Tecla

EL SALVADOVITAMIN, N.E.C.
118NOT LISTED
75UNAPPROVED
1/21/2026LABORATORIOS VIJOSA

Santa Tecla

EL SALVADOVITAMIN, N.E.C.
118NOT LISTED
75UNAPPROVED
1/21/2026HECHO EN GUATEMALA POR PIERSAN C

Guatemala

GUATEMALAMEDROXYPROGESTERONE ACETATE (PROGESTIN)
118NOT LISTED
75UNAPPROVED
1/21/2026Abbvie Corporation

Saint-Laurent

CANADAANTIMIGRAINE, NEC
118NOT LISTED
75UNAPPROVED
1/21/2026Novartis Farma S.P.A.

Torre Annunziata

ITALYCARBAMAZEPINE (ANALGESIC)
118NOT LISTED
75UNAPPROVED
1/21/2026ARCUTIS BIOTHERAPEUTLCS

Westlake Village

UNITED STAROFLUMILAST (ENZYME INHIBITOR)
118NOT LISTED
75UNAPPROVED
1/21/2026Boehringer Ingelheim Canada

Burlington

CANADAEMPAGLIFLOZIN (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
1/21/2026LABORATORIOS PISA SA DE CV

Guadalajara

MEXICORASAGILINE MESYLATE (ANTI-PARKINSONIAN)
118NOT LISTED
75UNAPPROVED
1/21/2026FARMACIAS SIMILARES LAB S A

Ciudad De Mexic

MEXICOPROBIOTICS (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)
118NOT LISTED
75UNAPPROVED
1/21/2026GRUNENTHAL DE MEXICO S A DE CV

Tlalpan

MEXICOAMANTADINE HCL (ANTI-VIRAL)
118NOT LISTED
75UNAPPROVED
1/21/2026AMSA LABORATORIES

Coyoacan

MEXICOPRAMIPEXOLE (ANTI-PARKINSONIAN)
118NOT LISTED
75UNAPPROVED
1/21/2026PSICOFARMA

C.P.

MEXICOBIPERIDEN (ANTI-CHOLINERGIC)
118NOT LISTED
75UNAPPROVED
1/21/2026Olcare Laboratories

Dist. Surendrasagar

INDIAXYLOMETAZOLINE HCL (ADRENERGIC)
118NOT LISTED
75UNAPPROVED
1/21/2026IPCA LABORATORIES LTD

Mumbai

INDIAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
75UNAPPROVED
1/21/2026GLAXOSMITHLINE CONSUMER HEALTHCA

Patiala

INDIAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
75UNAPPROVED
1/21/2026Macleods Pharmaceuticals Ltd

Mumbai

INDIAFEXOFENADINE HCL (ANTI-ASTHMATIC)
118NOT LISTED
75UNAPPROVED
1/21/2026IPCA LABORATORIES LTD

Mumbai

INDIAAZITHROMYCIN (MACAROLIDES)
118NOT LISTED
75UNAPPROVED
1/21/2026BC LTD C/O PASTURE

Singapore

SINGAPOREMIRABEGRON (ADRENERGIC)
75UNAPPROVED
1/21/2026unilever

Ho Chi Minh

VIETNAMSODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
75UNAPPROVED
1/21/2026Vaidyaratnam Nursing Home

Thrissur Kerala

INDIACALCIUM (MINERAL)
75UNAPPROVED
1/21/2026Maharishi Ayurveda Products

New Delhi

INDIACAMPHOR (ANTI-PRURITIC)
75UNAPPROVED
1/21/2026THE ARYA VAIDYA PHARMACY CBE LTD

Kanjikode Palakkad Ke

INDIAASPIRIN (ANALGESIC)
75UNAPPROVED
1/21/2026Kottakkal Arya Vaidya Sala

Kerala

INDIAMETFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
1/21/2026THE ARYA VAIDYA PHARMACY CBE LTD

Kanjikode Palakkad Ke

INDIAPROSTAGLANDIN N.E.C.
75UNAPPROVED
1...456...10077

About This Page

This page displays 50 FDA import refusal records from 21 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 508 (NO 510(K)), 341 (REGISTERED), 75 (UNAPPROVED) and 2 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 5 of 10,077 • Showing records 201-250 of 503,850 total