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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
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
1/21/2026Sanofi Medley Farmaceutica Ltda.

Suzano

BRAZILLEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
1/21/2026ACHE LABORATORIOS FARMACEUTICOS

Sao Paulo

BRAZILDESVENLAFAXINE SUCCINATE
75UNAPPROVED
1/21/2026Aspen Farmaceutica S/A

Sao Paulo

BRAZILTRAZODONE HCL (ANTI-DEPRESSANT)
75UNAPPROVED
1/21/2026NOVAMED FABRICACAO DE PRODUCTOS

Manaus

BRAZILQUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
1/21/2026ODONTOLGIA CAMPAGNONE

Valinhos

BRAZILORPHENADRINE CITRATE (RELAXANT)
75UNAPPROVED
1/21/2026ODONTOLGIA CAMPAGNONE

Valinhos

BRAZILSILDENAFIL CITRATE (REGULATOR)
75UNAPPROVED
1/20/2026societatea comerciala TAINET, SRL

Comrat

MOLDOVASYRUPS AND MOLASSES, N.E.C.
3887ADDDRUGBIO
1/20/2026Shree Bhagwati Flour & Foods PVT. LTD

Changodar

INDIAGRAM FLOUR
3886FSVP VIO
1/20/2026Shree Bhagwati Flour & Foods PVT. LTD

Changodar

INDIAGRAM FLOUR
3886FSVP VIO
1/20/2026Shree Bhagwati Flour & Foods PVT. LTD

Changodar

INDIAGRAM FLOUR
3886FSVP VIO
1/20/2026Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
1/20/2026ANHUI DONG BAO FOOD CO.,LTD.

Hefei City

CHINALEAF & STEM VEGETABLES, N.E.C.
3846807REFUSAL
1/20/2026LIW INNOVATION AB

Hokerum

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
1/20/2026PT. Tamron Akuatik Produk Industri

Serang

INDONESIASHRIMP & PRAWNS, BREADED
3220NITROFURAN
1/20/2026societatea comerciala TAINET, SRL

Comrat

MOLDOVAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
1/20/2026societatea comerciala TAINET, SRL

Comrat

MOLDOVAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
1/20/2026societatea comerciala TAINET, SRL

Comrat

MOLDOVAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
1/20/2026Gui Nan Hong Company Limited

Sheung Wan

HONG KONGWOLFBERRY (CHINESE OR SOUTHEAST ASIAN BERRY OF THE CHINESE MATRIMONY VINE, W/SLIGHT LICORICE FLAVOR)
482NUTRIT LBL
1/20/2026Gui Nan Hong Company Limited

Sheung Wan

HONG KONGHERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
1/20/2026NANJING CASELA TECHNOLOGIES CORP

Nanjing

CHINAFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
1/20/2026NANJING CASELA TECHNOLOGIES CORP

Nanjing

CHINAFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
1/20/2026NANJING CASELA TECHNOLOGIES CORP

Nanjing

CHINAFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
1/20/2026Grupo Gamesa, S.A. De C.V.

San Nicolas De Los Garza

MEXICOPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
324NO ENGLISH
1/20/2026VALLON FARMDIRECT PVT LTD

Jodhpur

INDIASPICES, GROUND, CRACKED, ETC., N.E.C.
308MFR INSAN
1/20/2026CHENGDU FINC BIO-TECH CO., LTD.

Chengdu

CHINATSO GU (DRIED CHINESE GRASS MUSHROOMS, HAVE STRONGER FRAGRANCE THAN CHINESE DRIED MUSHROOMS)
295LISTERIA
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About This Page

This page displays 50 FDA import refusal records from 16 countries. Records on this page involve violations including 118 (NOT LISTED), 75 (UNAPPROVED), 3887 (ADDDRUGBIO), 3886 (FSVP VIO), 3854 (TPLKUSSLLB) and 8 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 6 of 10,077 • Showing records 251-300 of 503,850 total