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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
11/10/2025Novo Nordisk A/S

Bagsvard

DENMARKINSULIN (INJ) (ANTI-DIABETIC)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREPASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KORECLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREMOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREPASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREMOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025AbbVie Inc.

North Chicago

UNITED STAONABOTULINUMTOXINA
75UNAPPROVED
11/10/2025BC LTD C/O PASTURE

Singapore

SINGAPORERIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
11/10/2025NIRVAIR SINGH

Assandh

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/10/2025UNKNOWN MANUFACTURET

UNKNOWN

CANADAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
11/10/2025CONSUMER HEALTHCARE GSK

Philadelphia

UNITED STAAZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC)
75UNAPPROVED
11/10/2025COCOONCENTER

La Veuve

FRANCEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
11/10/2025Medytox Inc.

Cheongju

SOUTH KOREONABOTULINUMTOXINA
75UNAPPROVED
11/10/2025KUNAL PATEL

Napad Talpad

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
11/10/2025GLAXO SMITH KLINE

London

UNITED KINFLUTICASONE PROPIONATE (BRONCHODILATOR)
75UNAPPROVED
11/10/2025COSMAX, INC.

Hwaseong-si

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/10/2025Pfizer Ireland Pharmaceuticals

Dublin 14

IRELANDAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
11/10/2025KOREA STAR

Incheon

SOUTH KOREACYCLOVIR (ANTI-VIRAL)
75UNAPPROVED
11/10/2025E11EMENT INC.

Scarborough

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/10/2025E11EMENT INC.

Scarborough

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/10/2025E11EMENT INC.

Scarborough

CANADAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
11/10/2025RTS Cosmetic Co., Ltd.

Namdong-gu

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/10/2025COSMAX, INC.

Hwaseong-si

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/10/2025RTS Cosmetic Co., Ltd.

Namdong-gu

SOUTH KOREOTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
11/10/2025COSMAX, INC.

Hwaseong-si

SOUTH KOREFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
11/10/2025OLCARE LABORATORIES

Wadhwancty

INDIAVITAMIN B6 (PYRIDOXINE)
75UNAPPROVED
11/10/2025GLENMARK PHARMACEUTICAL

Baddi

INDIATELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
11/10/2025CORONO REMEDIES PVT

Gujrat

INDIAROSUVASTATIN CALCIUM
75UNAPPROVED
11/10/2025OLCARE LABORATORIES

Wadhwancty

INDIALINAGLIPTIN (ANTI-DIABETIC)
75UNAPPROVED
11/10/2025MANKIND PHARMA LTD DORNING

Sikkim

INDIAMECOBALAMIN (VITAMIN)
75UNAPPROVED
11/10/2025Usv Limited

Bangalore

INDIAASPIRIN (ANALGESIC)
75UNAPPROVED
11/10/2025SBL Private Limited

East Delhi

INDIAZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN)
75UNAPPROVED
11/10/2025INTAS PHARMACEUTICALS LTD

Ahmedabad

INDIADIVALPROEX SODIUM (ANTI-CONVULSANT)
75UNAPPROVED
11/10/2025EXIZEN LIFESCIENCES LLP

Hyderabad

INDIAESCITALOPRAM OXALATE
75UNAPPROVED
11/10/2025Square Pharmaceuticals PLC

Gazipur

BANGLADESHASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
11/10/2025The ACME Laboratories Ltd.

Dhaka

BANGLADESHASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
11/10/2025Kolmar Korea Co., Ltd. Bucheon Factory

Bucheon

SOUTH KOREHOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN)
75UNAPPROVED
11/10/2025KOLMAR BNH CO.,LTD.(SBT)

Sejong

SOUTH KOREAVOBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN)
75UNAPPROVED
11/10/2025Kolmar Korea Co., Ltd. - Gwanjeong Factory

Chungcheongnam-Do

SOUTH KOREZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN)
75UNAPPROVED
11/10/2025Bayer S.A.

Sao Paulo

BRAZILRISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
11/10/2025Abbott Laboratorios do Brasil Ltda

Sao Paulo

BRAZILVALPROATE SODIUM (ANTI-CONVULSANT)
75UNAPPROVED
11/10/2025GELPHARMA S. A. DE C. V.

Zapopan

MEXICOVITAMIN, N.E.C.
75UNAPPROVED
11/10/2025LABORATORIO ALPHARMA PNT

Azcapotzalco

MEXICOACARBOSE (INHIBITOR (DECARBOXYLASE))
75UNAPPROVED
11/10/2025LABORATORIO SILANES

Hidalgo

MEXICOGLIMEPIRIDE (ANTI-DIABETIC)
75UNAPPROVED
11/10/2025Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)

Tlajomulco De Zuniga

MEXICOMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
11/10/2025ELANCO US INC

Indianapolis

UNITED STATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
11/10/2025SANOTH CONSUMER HEALTHCARE INDIA

Goa

INDIAFEXOFENADINE HCL (ANTI-ASTHMATIC)
75UNAPPROVED
11/10/2025TANMED PHARMA IP

Nagar

INDIANAPROXEN (ANTI-INFLAMMATORY)
75UNAPPROVED
11/10/2025SUN PHARMA LABORATORIES LTD

Assam

INDIALEVOCETIRIZINE DIHYDROCHLORIDE
75UNAPPROVED
11/10/2025ZYDUS MEDICA ZYDUS HEALTH CARE

Ahmedabad

INDIADEXAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 12 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 95 of 10,038 • Showing records 4,701-4,750 of 501,854 total