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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/9/2026Windlas Biotech Ltd

Dehradun

INDIACINNARIZINE (ANTI-HISTAMINIC)
75UNAPPROVED
1/9/2026LIFE VISION HEALTHCARE

SOLAN

INDIABETAHISTINE HCL (VASODILATOR)
75UNAPPROVED
1/9/2026Glassco Laboratory Equipment Behind S.D. College

Ambala Cantt

INDIASULFABENZAMIDE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026Recalcine Labs Sa

Santiago

CHILESULFABENZAMIDE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026LABORATORIOS ROEMMERS

Montevideo

URUGUAYSULFABENZAMIDE (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026OM PHARMA SA

Lima

PERUPANTOPRAZOLE SODIUM
75UNAPPROVED
1/9/2026Roemmers Lab

Buenos Aires

ARGENTINAOLMESARTAN MEDOXOMIL
75UNAPPROVED
1/9/2026Lab Mk

Cali

COLOMBIAHYDROCHLOROTHIAZIDE (DIURETIC)
75UNAPPROVED
1/9/2026Olive Healthcare

Daman

INDIAPROGESTERONE (PROGESTIN)
75UNAPPROVED
1/9/2026Shree Baidyanath Ayurved Bhawan Ltd

Jhansi

INDIAASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
1/9/2026Hiral Labs

Roorkee

INDIAFOLIC ACID (VITAMIN)
75UNAPPROVED
1/9/2026Hiral Labs

Roorkee

INDIAMECLIZINE HCL (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
1/9/2026ATHILO LIFESCIENCES LLP

Ahmedabad

INDIALOPERAMIDE (ANTI-PERISTALTIC)
75UNAPPROVED
1/9/2026Abbott India Limited

Puducherry

INDIADYDROGESTERONE (PROGESTIN)
75UNAPPROVED
1/9/2026SYSTOLE REMEDIES PVT LTD

Kala Amb

INDIADOXYLAMINE SUCCINATE (ANTI-HISTAMINIC)
75UNAPPROVED
1/9/2026GILEAD SCIENCES CANADA INC

Mississauga

CANADAEMTRICITABINE
75UNAPPROVED
1/9/2026LABORATORIO EUROFARMA EN MEXICO

Tultitlan

MEXICOCEPHALEXIN (CEPHALOSPORINS)
75UNAPPROVED
1/9/2026LABORATORIES SENOSIAN SA DE CU

Santa Rita

MEXICOLIDOCAINE HCL (ANESTHETIC)
75UNAPPROVED
1/9/2026Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
1/9/2026NOVO NORDISK SERV PROF S A DE CV

Polando

MEXICOLIRAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/9/2026ARMSTRONG LABORATORIOS DE MEXICOS.

Ciudad De Mexico

MEXICOLEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
1/9/2026DRHOMEO PVT LTD

Chandigarh

INDIACALCIUM (MINERAL)
75UNAPPROVED
1/9/2026DRHOMEO PVT LTD

Chandigarh

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/9/2026Medice Arzneimittel Puetter Gmbh

Iserlohn

GERMANYLISDEXAMFETAMINE (STIMULANT)
75UNAPPROVED
1/9/2026Glaxosmithkline

Oslo

NORWAYSUMATRIPTAN SUCCINATE (ANTIMIGRAINE AGENT)
75UNAPPROVED
1/9/2026ORIFARM GENERICS AS

Odense S

DENMARKMETOCLOPRAMIDE (ANTACID)
75UNAPPROVED
1/9/2026Pharmachemie B.V. dba Teva Pharmachemie

Haarlem

NETHERLANDLISDEXAMFETAMINE (STIMULANT)
75UNAPPROVED
1/9/2026H. Lundbeck A/S

Valby

DENMARKAMITRIPTYLINE HCL (ANTI-DEPRESSANT)
75UNAPPROVED
1/9/2026EUROFARMA LABORATORIOS LTDA

Sao Paulo

BRAZILFLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026FARMOQUIMICA

Rio De Janeiro

BRAZILANTIPARASITIC, N.E.C.
75UNAPPROVED
1/9/2026ACHE LABORATORIOS FARMACEUTICOSSA

Sao Paulo

BRAZILMINOXIDIL (ANTI-HYPERTENSIVE)
75UNAPPROVED
1/9/2026ACHE LABORATORIOS FARMACEUTICOSSA

Sao Paulo

BRAZILDUTASTERIDE
75UNAPPROVED
1/9/2026LUPIN LTD

Sikkim

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
1/9/2026Pfizer Canada

Kirkland

CANADAAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
1/9/2026CYNDEA PHARMA S.L.

Soria

SPAINPROGESTERONE (PROGESTIN)
75UNAPPROVED
1/9/2026RB Salute Mexico SA de CV

Coyoacan

MEXICOACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
1/9/2026CIPLA LTD

Ahmedabad

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
1/9/2026GLAXOSMITHKLINE PHARMACEUTICALS

Aurangabad

INDIAHOMEOPATHIC ANTI-INFECTIVE
75UNAPPROVED
1/9/2026SUN PHARMACEUTICAL INDUSTRIES

Gujarant

INDIARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026SUN PHARMACEUTICAL INDUSTRIES

Gujarant

INDIARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026SUN PHARMACEUTICAL INDUSTRIES

Gujarant

INDIARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026SUN PHARMACEUTICAL INDUSTRIES

Gujarant

INDIARIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026LABORATORIO FRANCO COLOMBIA

Valle Del Cauca

COLOMBIAFLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026NOVO NORDISK

Whitefield

BULGARIASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/9/2026WENG SENG HENG MEDICAL FACTORY

Pulau Pinang

MALAYSIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/9/2026LIDIA GOMEZ

Guatemala

GUATEMALAVITAMIN, N.E.C.
75UNAPPROVED
1/9/2026LIDIA GOMEZ

Guatemala

GUATEMALAVITAMIN, N.E.C.
75UNAPPROVED
1/9/2026PEACH HERBALS

14440

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/9/2026PEACH HERBALS

14440

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/9/2026SHREE PHARMA

Nagpur

INDIATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
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About This Page

This page displays 50 FDA import refusal records from 18 countries. Records on this page involve violations including 75 (UNAPPROVED). Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 23 of 10,077 • Showing records 1,101-1,150 of 503,850 total