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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/6/2026Pfizer

Manhattan

UNITED STAMETHOTREXATE (ANTI-NEOPLASTIC)
75UNAPPROVED
1/6/2026Janytree Inc.

Geumcheon

SOUTH KOREFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
1/6/2026MEGALABS COLOMBIA SAS

Bogota

COLOMBIAANTI-HISTAMINIC N.E.C.
75UNAPPROVED
1/6/2026Tecnoquimicas S.A.

Cali

COLOMBIADICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
1/6/2026Altea Farmaceutica

Bogota

COLOMBIAGUAIFENESIN (EXPECTORANT)
75UNAPPROVED
1/6/2026TECNOFAR TQ SAS

Cauca

COLOMBIAZINC SULFATE ASTRINGENT/ANTI-PERSPIRANT)
75UNAPPROVED
1/6/2026SANOFI MEDLEY FARMACEUTICA LTDA

Sao Paulo

BRAZILFEXOFENADINE HCL (ANTI-ASTHMATIC)
75UNAPPROVED
1/6/2026MUNDIAL FARMACEUTICA

Bogota

COLOMBIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
1/6/2026SALUD PHARMA LABS

Bogota

COLOMBIAANTI-HISTAMINIC N.E.C.
75UNAPPROVED
1/6/2026LABORATORIOS RICHMOND COLOMBIA S.A.S.

Bogota

COLOMBIAANTI-HISTAMINIC N.E.C.
75UNAPPROVED
1/6/2026MUNDIAL FARMACEUTICA

Bogota

COLOMBIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
1/6/2026PHARMETIQUE SA

Bogota

COLOMBIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
1/6/2026SIEGFRIED

Bogota

COLOMBIAEXPECTORANT N.E.C.
75UNAPPROVED
1/6/2026Syntofarma

Bogata

COLOMBIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
1/6/2026COASPHARMA S.A.S.

Bogota

COLOMBIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
1/6/2026Ini Health And Nutrition Colon

Old Harbour

JAMAICAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/6/2026Ini Health And Nutrition Colon

Old Harbour

JAMAICAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/6/2026Ini Health And Nutrition Colon

Old Harbour

JAMAICAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/6/2026Ini Health And Nutrition Colon

Old Harbour

JAMAICAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/6/2026Boehringer Ingelheim Canada

Burlington

CANADAEMPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
1/6/2026Laboratorios Liomont, S.A. de C.V.

Ciudad De Mexico

MEXICOLIDOCAINE HCL (ANESTHETIC)
75UNAPPROVED
1/6/2026RABBECA BIYELA

Lusaka Kafue

ZAMBIASARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
62NEEDS FCE
83NO PROCESS
1/6/2026Taizhou Kangping Medical Science And Technology Co., Ltd.

Taizhou

CHINAISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
27DRUG GMPS
3280FRNMFGREG
1/6/2026Taizhou Kangping Medical Science And Technology Co., Ltd.

Taizhou

CHINAISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
27DRUG GMPS
3280FRNMFGREG
1/6/2026Taizhou Kangping Medical Science And Technology Co., Ltd.

Taizhou

CHINAISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL)
27DRUG GMPS
3280FRNMFGREG
1/6/2026Intas Pharmaceuticals Limited

Ahmedabad

INDIAMINOXIDIL (ANTI-HYPERTENSIVE)
27DRUG GMPS
1/6/2026Nowcos Co., Ltd

Sejong

SOUTH KOREOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
27DRUG GMPS
1/6/2026IRC WILLIAM DI CARLO SRL

Sulmona

ITALYCHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT)
11UNSAFE COL
3865COLORLABEL
1/6/2026IRC WILLIAM DI CARLO SRL

Sulmona

ITALYCHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT)
11UNSAFE COL
3865COLORLABEL
1/6/2026IRC WILLIAM DI CARLO SRL

Sulmona

ITALYCHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT)
11UNSAFE COL
3865COLORLABEL
1/6/2026IRC WILLIAM DI CARLO SRL

Sulmona

ITALYCHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT)
11UNSAFE COL
3865COLORLABEL
1/6/2026IRC WILLIAM DI CARLO SRL

Sulmona

ITALYCHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT)
11UNSAFE COL
3865COLORLABEL
1/6/2026IRC WILLIAM DI CARLO SRL

Sulmona

ITALYCHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT)
11UNSAFE COL
3865COLORLABEL
1/6/2026IRC WILLIAM DI CARLO SRL

Sulmona

ITALYCHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT)
11UNSAFE COL
3865COLORLABEL
1/6/2026IRC WILLIAM DI CARLO SRL

Sulmona

ITALYCHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT)
11UNSAFE COL
3865COLORLABEL
1/6/2026IRC WILLIAM DI CARLO SRL

Sulmona

ITALYCHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT)
11UNSAFE COL
3865COLORLABEL
1/6/2026IRC WILLIAM DI CARLO SRL

Sulmona

ITALYCHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT)
11UNSAFE COL
3865COLORLABEL
1/6/2026SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
1/6/2026SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
1/6/2026SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
1/6/2026SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
1/6/2026SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
1/6/2026SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
1/6/2026Comestibles Master Co., Ltd.

Taichung

TAIWANSTRAWBERRY, JAM, JELLY, PRESERVES, MARMALADE, BUTTER AND CANDIED
11UNSAFE COL
274COLOR LBLG
1/6/2026STC INDIA PVT LTD.

Mumbai

INDIAWHOLE SPICE, N.E.C.
11UNSAFE COL
274COLOR LBLG
1/6/2026BARCEL, S.A. DE C.V

Pueblo Infonavit Lerma

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
1/6/2026UNILEVER SOUTH AFRICA

Durban

SOUTH AFRIMUSHROOM SOUP, DRIED
11UNSAFE COL
1/6/2026UNILEVER SOUTH AFRICA

Durban

SOUTH AFRIMUSHROOM SOUP, DRIED
11UNSAFE COL
1/6/2026Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
1/6/2026Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
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About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 27 (DRUG GMPS), 3280 (FRNMFGREG) and 4 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 32 of 10,077 • Showing records 1,551-1,600 of 503,850 total