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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
11/13/2025Dabur India

Solan

INDIAHERBALS & BOTANICAL TEAS, N.E.C.
75UNAPPROVED
11/13/2025Dabur India

Solan

INDIAHERBALS & BOTANICAL TEAS, N.E.C.
75UNAPPROVED
11/13/2025CIPLA LTD

Sikkim

INDIASODIUM CHLORIDE (REPLENISHER)
75UNAPPROVED
11/13/2025AMRUTANJAN HEALTH CARE

Mylapore

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
11/13/2025CORAT LABORATORIES

Dehradun

INDIABENZOCAINE (ANESTHETIC)
75UNAPPROVED
11/13/2025WEXCARE PHARMACEUTICAL PVT LTD

Mehsana

INDIACHLORHEXIDINE GLUCONATE
75UNAPPROVED
11/13/2025WEXCARE PHARMACEUTICAL PVT LTD

Mehsana

INDIACHLORZOXAZONE (RELAXANT)
75UNAPPROVED
11/13/2025Microlabs Ltd

Sikkim

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
11/13/2025CORONA REMEDIES PVT. LTD

Tehsil Solan

INDIAERGOTAMINE TARTRATE (ANALGESIC)
75UNAPPROVED
11/13/2025Eris Lifesciences

Kamrup

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/13/2025Zydus Healthcare

Rangpo Sikkim

INDIAIPRATROPIUM BROMIDE (BRONCHODILATOR)
75UNAPPROVED
11/13/2025Zydus Healthcare

Rangpo Sikkim

INDIAIPRATROPIUM BROMIDE (BRONCHODILATOR)
75UNAPPROVED
11/13/2025UNISON PHARMACEUTICALS PVT LTD

SANAND

INDIAATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
11/13/2025Apex Laboratories Private Ltd

Alathur

INDIAZINC (MINERAL)
75UNAPPROVED
11/13/2025Eris Lifesciences

Kamrup

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/13/2025GLENMARK PHARMACEUTICAL

Baddi

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/13/2025PURE&PURE HEALTH CARE PVT LTD

Sidcul Ranipure

INDIAROSUVASTATIN CALCIUM
75UNAPPROVED
11/13/2025IPCA LABORATORIES LIMITED

BHARIKHOLA

INDIADUTASTERIDE
75UNAPPROVED
11/13/2025IPCA LABORATORIES LTD

Mumbai

INDIAMIRABEGRON (ADRENERGIC)
75UNAPPROVED
11/13/2025CIPLA LIMITED

Mumbai

INDIAMETOPROLOL (ANTI-ADRENERGIC)
75UNAPPROVED
11/13/2025CIPLA LIMITED

Mumbai

INDIATORSEMIDE (DIURETIC)
75UNAPPROVED
11/13/2025Unique Pharmaceutical Laboratories (A Div. of JB Chemicals & Pharmaceuticals Ltd)

Daman

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/13/2025SANOFI HEALTHCARE INDIA PVT LTD

Verna

INDIARAMIPRIL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/13/2025RPG LIFE SCIENCE LTD

Ankleshwar

INDIASPIRONOLACTONE (DIURETIC)
75UNAPPROVED
11/13/2025JM LIFESCIENCES PRIVATE LIMITED

Mumbai

INDIACYSTEINE HYDROCHLORIDE (NUTRIENT/TONIC)
75UNAPPROVED
11/13/2025Laborate Pharmaceu

Panipat

INDIADEXAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
11/13/2025NEON LABS

Mumbai

INDIALIDOCAINE HCL (ANESTHETIC)
75UNAPPROVED
11/13/2025NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
11/13/2025Delpharm Milano Srl

Segrate

ITALYCARVEDILOL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/13/2025SESDERMA SL

Pucol

SPAINOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/13/2025GILEAD SCIENCES IRELAND UC

Cork

IRELANDDASATINIB
75UNAPPROVED
11/13/2025NOVAG INFANCIA SA

Coyoacan Mexica City

MEXICOMETOCLOPRAMIDE HCL (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
11/13/2025PRODUCTOS CIENTIFICOS SA DE

Del Vale

MEXICOSIMETHICONE (ANTI-FLATULENT)
75UNAPPROVED
11/13/2025ULTRA LABORATORY

Guadalajara

MEXICOESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
75UNAPPROVED
11/13/2025Aventis Pharma

Guatemala

GUATEMALADIPYRONE (ANALGESIC)
75UNAPPROVED
11/13/2025GILEAD SCIENCES IRELAND UC

Cork

IRELANDEFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL)
75UNAPPROVED
11/13/2025SURE SHOT HERBALS

Yamunanagar

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
11/13/2025Infarma

Tegucigalpa

HONDURASFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
75UNAPPROVED
11/13/2025COSRX INC

Seongnam

SOUTH KORESALICYLIC ACID (KERATOLYTIC)
75UNAPPROVED
11/13/2025GABARIT LASER

Laubach

FRANCELASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS
47NON STD
476NO REGISTR
11/13/2025Swizzels Matlow Limited

High Peak

UNITED KINCANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
11/13/2025Swizzels Matlow Limited

High Peak

UNITED KINCANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
11/13/2025Swizzels Matlow Limited

High Peak

UNITED KINCANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
11/13/2025Swizzels Matlow Limited

High Peak

UNITED KINCANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
11/13/2025Stc India Pvt. Ltd.

Mumbai

INDIAMINT CANDY, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
11/13/2025AGROMOD, S.A. DE C.V. - Ranch Santa Teresa

Suchiate

MEXICOPAPAYA (PAPAW) (SUBTROPICAL AND TROPICAL FRUIT)
9SALMONELLA
11/13/2025Fujian Fuzhou Tian Shan Foods Co., Ltd

Fuzhou

CHINAFUNGUS, BLACK (CLOUD EARS), WHOLE (BUTTON) (FUNGI)
9SALMONELLA
11/13/2025Con. I. Ioannidis S.A.

Kalochori

GREECEOLIVES, BLACK, (PIT FRUIT)
3898INADPRCCTL
11/13/2025Con. I. Ioannidis S.A.

Kalochori

GREECEOLIVES, BLACK, (PIT FRUIT)
3898INADPRCCTL
11/13/2025SOCIETE DE CONSERVERIE EN AFRIQUE (SCA S.A.)

Dakar

SENEGALTUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
3878POISONORD
3898INADPRCCTL
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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), 47 (NON STD), 476 (NO REGISTR), 11 (UNSAFE COL), 9 (SALMONELLA) and 3 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 87 of 10,038 • Showing records 4,301-4,350 of 501,854 total