ImportRefusal LogoImportRefusal

Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
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
12/16/2025NGP TOBACCO APS

Norager

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
12/16/2025Donggang City Tianhong Aquatic Foodstuff Co., Ltd

Dandong

CHINACROAKER
3846807REFUSAL
12/16/2025HELIX SWEDEN AB

Helsingborg

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
12/16/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
12/16/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
12/16/2025SHANGHAI JEAN SEAN PHARMA CO.LTD.

Shanghai

CHINAOTHER PET FOOD, N.E.C.
3421MELAMINE

About This Page

This page displays 50 FDA import refusal records from 13 countries. Records on this page involve violations including 118 (NOT LISTED), 75 (UNAPPROVED), 62 (NEEDS FCE), 83 (NO PROCESS), 11 (UNSAFE COL) and 10 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 17 of 10,038 • Showing records 801-850 of 501,854 total