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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/22/2026FRESENIUS KABI BIDIPHAR JSC

Quy Nhon City

VIETNAMSODIUM CHLORIDE (REPLENISHER)
118NOT LISTED
3280FRNMFGREG
+1 more
1/22/2026WWW.R3JUVEN8.ET

Herston

AUSTRALIAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
1/22/2026LDI LAPUKE DRUG INC

Quezon

PHILIPPINEEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
1/22/2026LDI LAPUKE DRUG INC

Quezon

PHILIPPINEEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
3280FRNMFGREG
+1 more
1/22/2026HL CORP SHENZHEN

Shenzhen

CHINACOMPONENTS, WHEELCHAIR
118NOT LISTED
3280FRNMFGREG
1/22/2026Merz North America, Inc.

Franksville

UNITED STAIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
3280FRNMFGREG
1/22/2026GUANDONG BESTEK TECHNOLOGY CO.,LTD

Heyuan

CHINAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
3280FRNMFGREG
1/22/2026GLIDEWELL MEXICO

Mexico City

MEXICOMOUTHGUARD
118NOT LISTED
3280FRNMFGREG
1/22/2026COIZ Co., Ltd.

Seoul

SOUTH KORETITANIUM DIOXIDE (PROTECTANT)
118NOT LISTED
3280FRNMFGREG
1/22/2026COSRX INC

Seongnam

SOUTH KOREULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
3280FRNMFGREG
1/22/2026SUZHOU HEALTHLINE MEDICAL CO.,LTD.

Suzhou

CHINABANDAGE, ELASTIC
118NOT LISTED
3280FRNMFGREG
1/22/2026NATURAL MEDY DISTRIBUCIONES SAS

Cali

COLOMBIAVITAMIN, N.E.C.
118NOT LISTED
3260NO ENGLISH
+2 more
1/22/2026INDISTRIAL VALLERA DE MEXICALI S

Mexicali

MEXICOMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
118NOT LISTED
508NO 510(K)
1/22/2026INDISTRIAL VALLERA DE MEXICALI S

Mexicali

MEXICOMONITOR, PHYSIOLOGICAL, PATIENT (WITHOUT ARRHYTHMIA DETECTION OR ALARMS)
118NOT LISTED
508NO 510(K)
1/22/2026INDISTRIAL VALLERA DE MEXICALI S

Mexicali

MEXICOOXIMETER
118NOT LISTED
508NO 510(K)
1/22/2026EXCELLENT HI CARE

Chennai

INDIALENS, INTRAOCULAR
118NOT LISTED
237NO PMA
+1 more
1/22/2026TAIZHOU IUQIAO INNOVATION GLASSES CO.,LTD.

Yiwu City

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
+2 more
1/22/2026Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREPROTECTANT N.E.C.
118NOT LISTED
1/22/2026Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREPROTECTANT N.E.C.
118NOT LISTED
1/22/2026BC LTD C/O PASTURE

Singapore

SINGAPOREMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/22/2026Abbvie Biotechnology Gmbh

Ludwigshafen Am Rhein

GERMANYADALIMUMAB
75UNAPPROVED
1/22/2026Gillette Diversified Operations Private Limited

Ahmedabad

INDIACAMPHOR (ANTI-PRURITIC)
75UNAPPROVED
1/22/2026PLIZER HEALTHCARE INDIA

Mumbai

INDIAMETHYLPREDNISOLONE (GLUCOCORTICOID)
75UNAPPROVED
1/22/2026ZYDUS HEALTH CARE LTD

East Sikkim

INDIATHEOPHYLLINE (BRONCHODILATOR)
75UNAPPROVED
1/22/2026Unison Pharmaceuticals

Ahmedabad

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
1/22/2026ALEMBIC PHARMACEUTICALS

Namchi

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
1/22/2026Cipla Pvt Ltd

Solan

INDIAALBUTEROL (BRONCHODILATOR)
75UNAPPROVED
1/22/2026AstraZeneca Pharmaceuticals LP

Mount Vernon

UNITED STADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
1/22/2026MSD PHARMACEUTICALS PVT LTD

T Begur

INDIASITAGLIPTIN PHOSPHATE (ANTI-DIABETIC)
75UNAPPROVED
1/22/2026CHINOIN LABORATORIES

Mexico City

MEXICODEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID)
75UNAPPROVED
1/22/2026CHINOIN LABORATORIES

Mexico City

MEXICOVITAMIN B12 (CYANOCOBALAMIN)
75UNAPPROVED
1/22/2026Laboratorios Paill

San Salvador

EL SALVADODICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
1/22/2026HAUT PHARMA

Guatamala City

GUATEMALATRIAMCINOLONE (GLUCOCORTICOID)
75UNAPPROVED
1/22/2026Laboratorios Quimico Farmaceuticos Lancasco SA

Guatemala

GUATEMALAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
1/22/2026KYOWA KIRIN HOLDINGS B.V. ON BEHALF OF KYOWA KIRIN CO., LTD

Hoofddorp

NETHERLANDBUROSUMAB-TWZA
75UNAPPROVED
1/22/2026Novo Nordisk A/S

Kalundborg

DENMARKINSULIN DEGLUDEC
75UNAPPROVED
1/22/2026Caregen Co., Ltd.

Gunpo

SOUTH KOREWRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
75UNAPPROVED
1/22/2026ALEMBIC

Baroda

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
1/22/2026SUN PHARMA LABORATIROES

Sikkim

INDIALEVOCETIRIZINE DIHYDROCHLORIDE
75UNAPPROVED
1/22/2026Alkem Health Science

Sikkim

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
1/22/2026MICRO LABS LTD

Bangalore

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
1/22/2026MEDPRODUCTS LABORATORIO

Chichemecas

GUATEMALADEXAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
1/22/2026LABORATORIES SAIMED SA DE CV

San Salvador

EL SALVADOAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
1/22/2026Pharmachemie B.V. dba Teva Pharmachemie

Haarlem

NETHERLANDLEVOFLOXACIN (ANTI-BACTERIAL, PART III)
75UNAPPROVED
1/22/2026Synokem Pharmaecuticals Ltd

Uttarakhand

INDIADYDROGESTERONE (PROGESTIN)
75UNAPPROVED
1/22/2026Ontop Pharmaceuticals Ltd

Bangalore

INDIATRANEXAMIC ACID (HEMOSTATIC)
75UNAPPROVED
1/22/2026PURE AND CURE HEALTHCARE PVT LTD

Haridwar

INDIAISOXSUPRINE HCL (VASODILATOR)
75UNAPPROVED
1/22/2026ZEON BIOTECH

Ahmedbad

INDIAVITAMIN, N.E.C.
75UNAPPROVED
1/22/2026Sunvij Drugs Ltd

Gujarat

INDIAFOLIC ACID (VITAMIN)
75UNAPPROVED
1/22/2026WELLMAATS ORGANIC LIFESTYLE PVT

New Delhi

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1234...10077

About This Page

This page displays 50 FDA import refusal records from 15 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 75 (UNAPPROVED), 72 (NEW VET DR), 3260 (NO ENGLISH) and 4 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 2 of 10,077 • Showing records 51-100 of 503,850 total