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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
12/17/2025Synokem Pharmaceuticals Ltd

Haridwar

INDIAROSUVASTATIN CALCIUM
118NOT LISTED
12/17/2025SL SAMARTH LIFE SCIENCES PVT LTD

Pradesh

INDIAPYRIDOSTIGMINE BROMIDE (CHOLINERGIC)
118NOT LISTED
12/17/2025Sanofi Winthrop Industrie

Carbon Blanc CEDEX

FRANCECLOPIDOGREL BISULFATE (ANTI-COAGULANT)
118NOT LISTED
12/17/2025Windlas Biotech Ltd

Dehradun

INDIAMETOPROLOL (ANTI-ADRENERGIC)
118NOT LISTED
12/17/2025Cadila Pharmaceuticals Limited

Ahmedabad

INDIAVITAMIN, N.E.C.
118NOT LISTED
12/17/2025UNIVERSAL NUTRISCIENCE

Mumbai

INDIAEVENING PRIMROSE OIL (FATS AND LIPID SUBSTANCES)
118NOT LISTED
12/17/2025CADILA PHARMACEUTICAL LTD

Ahmedabad

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
12/17/2025ESCITALTNE BRAND

Ahmedabad

INDIAESCITALOPRAM OXALATE
118NOT LISTED
12/17/2025Zydus Cadila Healthcare Ltd

Ahmedabad

INDIARABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER)
118NOT LISTED
12/17/2025IPCA LABORATORIES LTD

Mumbai

INDIAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
12/17/2025CADILA PHARMACEUTICAL LTD

Ahmedabad

INDIACALCITRIOL (ANTI-HYPERCALCEMIC)
118NOT LISTED
12/17/2025Themis Pharmaceuticals

Vapi

INDIAMECOBALAMIN (VITAMIN)
75UNAPPROVED
12/17/2025FARM CIA YANOMELO LTDA

Goiania

BRAZILMINOXIDIL (ANTI-HYPERTENSIVE)
75UNAPPROVED
12/17/2025FAGRON DO BRASIL FARMACEUITICA L

Sao Paulo

BRAZILVITAMIN, N.E.C.
75UNAPPROVED
12/17/2025BAYER SA

Guatemala City

GUATEMALAVITAMIN D2 (CALCIFEROL)
75UNAPPROVED
12/17/2025BAYER SA

Guatemala City

GUATEMALAVITAMIN E (TOCOPHEROL)
75UNAPPROVED
12/17/2025BAYER SA

Guatemala City

GUATEMALAVITAMIN A
75UNAPPROVED
12/17/2025Emami Limited

Silvassa

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
12/17/2025SANSKAR AYUSHI MEDICARE PVT. LMT

Haridwar

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
12/17/2025SHREE DHANWANTRI HERBALS PRIVATE LIMITED

AMRITSAR

INDIACETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC)
75UNAPPROVED
12/17/2025Planet Ayurveda Private Limited

Sas Nagar (Mohali)

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
12/17/2025Planet Ayurveda Private Limited

Sas Nagar (Mohali)

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
12/17/2025Planet Ayurveda Private Limited

Sas Nagar (Mohali)

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
12/17/2025Planet Ayurveda Private Limited

Sas Nagar (Mohali)

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
12/17/2025FERNANDO DEL PIANO

Providencia

CHILEPHENFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
12/17/2025Phoenix International Trading Co., Ltd.

Ho Chi Minh

VIETNAMSAUCES, N.E.C.
62NEEDS FCE
83NO PROCESS
12/17/2025Phoenix International Trading Co., Ltd.

Ho Chi Minh

VIETNAMTOMATO SAUCE (WITH OTHER INGREDIENTS)
11UNSAFE COL
324NO ENGLISH
+2 more
12/17/2025STC INDIA PVT LTD.

Mumbai

INDIAMIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
11UNSAFE COL
274COLOR LBLG
12/17/2025STC INDIA PVT LTD.

Mumbai

INDIAMIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
11UNSAFE COL
274COLOR LBLG
12/17/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/17/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/17/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/17/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/17/2025SABRITAS PLANTA CELAYA

Celaya

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/17/2025Astra Sweets n.v.

Turnhout

BELGIUMJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
12/17/2025Jake S. A.

Molina De Segura

SPAINJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
12/17/2025Jake S. A.

Molina De Segura

SPAINJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
12/17/2025Jake S. A.

Molina De Segura

SPAINJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
12/17/2025Jake S. A.

Molina De Segura

SPAINJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
12/17/2025Jake S. A.

Molina De Segura

SPAINJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
12/17/2025Jake S. A.

Molina De Segura

SPAINJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
12/17/2025Jake S. A.

Molina De Segura

SPAINJELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
12/17/2025Bebidas Internacionales Bepensa, S.A. de C.V.

Santiago De Queretaro

MEXICOLIQUORS, N.E.C.
11UNSAFE COL
274COLOR LBLG
12/17/2025Stc India Pvt. Ltd.

Mumbai

INDIAMIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C.
11UNSAFE COL
274COLOR LBLG
12/17/2025Chupa Chups

SANT ESTEVE SESROVIRES

SPAINFLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
12/17/2025Chupa Chups

SANT ESTEVE SESROVIRES

SPAINFLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
12/17/2025Phoenix International Trading Co., Ltd.

Ho Chi Minh

VIETNAMCHILI SAUCE
11UNSAFE COL
12/17/2025Shan Foods (Private) Limited

Karachi

PAKISTANCUSTARD MIX
11UNSAFE COL
12/17/2025Shan Foods (Private) Limited

Karachi

PAKISTANCUSTARD MIX
11UNSAFE COL
12/16/2025Wadi El Nile for Food Industries

Sadat

EGYPTOLIVES (PIT FRUIT)
3898INADPRCCTL
83NO PROCESS

About This Page

This page displays 50 FDA import refusal records from 11 countries. Records on this page involve violations including 118 (NOT LISTED), 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 11 (UNSAFE COL) and 5 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 56 of 10,077 • Showing records 2,751-2,800 of 503,850 total