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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/9/2026Guangzhou Bause Cosmetics Co., Ltd.

Guangzhou

CHINAEYE SHADOW (EYE MAKEUP PREPARATIONS)
197COSM COLOR
1/9/2026Guangzhou Bause Cosmetics Co., Ltd.

Guangzhou

CHINAEYE SHADOW (EYE MAKEUP PREPARATIONS)
197COSM COLOR
1/9/2026Guangzhou Bause Cosmetics Co., Ltd.

Guangzhou

CHINAEYE SHADOW (EYE MAKEUP PREPARATIONS)
197COSM COLOR
1/9/2026Guangzhou Bause Cosmetics Co., Ltd.

Guangzhou

CHINAEYE SHADOW (EYE MAKEUP PREPARATIONS)
197COSM COLOR
1/9/2026GLOBAL-E C/O SWATI COSMETICS

Skurup

SWEDENLENS, CONTACT (DISPOSABLE)
118NOT LISTED
3280FRNMFGREG
+1 more
1/9/2026WEDERM

Seoul

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
2380NO PMA/PDP
+1 more
1/9/2026E-FILLERS SA

Athens

GREECEOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
118NOT LISTED
237NO PMA
+2 more
1/9/2026E-FILLERS SA

Athens

GREECEOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
118NOT LISTED
237NO PMA
+2 more
1/9/2026E-FILLERS SA

Athens

GREECEIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
1/9/2026MAP LOGISTICS

Guatemala

GUATEMALAVITAMIN B12 (CYANOCOBALAMIN)
75UNAPPROVED
1/9/2026MAP LOGISTICS

Guatemala

GUATEMALADICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
1/9/2026MAP LOGISTICS

Guatemala

GUATEMALAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
1/9/2026PZ CUSSONS NIGERIA PLC

Lagos

NIGERIACAMPHOR (ANTI-PRURITIC)
75UNAPPROVED
1/9/2026ABBOTT INDIA LIMITED

Thane

INDIAMENTHOL (ANTI-PRURITIC)
75UNAPPROVED
1/9/2026ABBOTT INDIA LIMITED

Thane

INDIATHYROXINE I 125 (RADIOACTIVE AGENT)
75UNAPPROVED
1/9/2026Intas Pharmaceuticals Ltd

South Sikkim

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
1/9/2026DR REDDYS LABORATORIES

Miyapur Hyderabad

INDIARABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER)
75UNAPPROVED
1/9/2026Cipla Ltd

Solapur

INDIAOFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026ALKEM HEALTH SCIENCE

Namthang

INDIACEFIXIME (CEPHALOSPORINS)
75UNAPPROVED
1/9/2026Mankind Pharma Ltd.

New Delhi

INDIACEFIXIME (CEPHALOSPORINS)
75UNAPPROVED
1/9/2026RELAX PHARMACEUTICALS PVT LTD

Pradesh

INDIACEFIXIME (CEPHALOSPORINS)
75UNAPPROVED
1/9/2026COPMED PHARMA PVT LTD

SIRMOUR

INDIACEFUROXIME AXETIL (CEPHALOSPORINS)
75UNAPPROVED
1/9/2026PUROBIEN LIFESCIENCES

Baddi

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
1/9/2026ZEISS PHARMA LIMITED

SAMBA

INDIACEFIXIME (CEPHALOSPORINS)
75UNAPPROVED
1/9/2026PUROBIEN LIFESCIENCES

Baddi

INDIACEFPODOXIME PROXETIL (CEPHALOSPORINS)
75UNAPPROVED
1/9/2026MED MANOR ORGANICS PVT LTD

Haridwar

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
1/9/2026WALLACE PHARMACEUTICALS PVT LTD

Solan

INDIACHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC)
75UNAPPROVED
1/9/2026Intas Pharmaceuticals Limited

Gangtok

INDIACINNARIZINE (ANTI-HISTAMINIC)
75UNAPPROVED
1/9/2026SUN PHARMA LTD

Solan

INDIACIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
1/9/2026Alkem Laboratories Limited

Namthang

INDIAANTI-EMETIC/NAUSEANT N.E.C.
75UNAPPROVED
1/9/2026ERIS THERAPEUTICS LTD

Ahmedabad

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
1/9/2026SUN PHARMACEUTICAL LTD

Kalan

INDIACIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
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
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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 197 (COSM COLOR), 118 (NOT LISTED), 3280 (FRNMFGREG), 508 (NO 510(K)), 2380 (NO PMA/PDP) and 2 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 25 of 10,077 • Showing records 1,201-1,250 of 503,850 total