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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
7/3/2025AJ LERO ENTERPRISES

Abuja

NIGERIAOMEGA-3 (FATS AND LIPID SUBSTANCES)
75UNAPPROVED
7/3/2025ANCIENT ORGANIC HERBAL ENTERPRIS

Osogbo

NIGERIAGINSENG (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
7/3/2025MULTISTREAM LTD

Lagos

NIGERIAASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
7/3/2025NATURATIVA FARMACIA LTD

Rio De Janeiro

BRAZILMINOXIDIL (ANTI-HYPERTENSIVE)
75UNAPPROVED
7/3/2025FARMACIA ANALITICA

Barra Da Tijuca

BRAZILCHROMIUM (MINERAL)
75UNAPPROVED
7/3/2025Eurofarma Laboratorios S.A.

Itapevi

BRAZILNANDROLONE DECANOATE (ANDROGEN)
75UNAPPROVED
7/3/2025Eurofarma Laboratorios S.A.

Itapevi

BRAZILTESTOSTERONE PROPIONATE (ANDROGEN)
75UNAPPROVED
7/3/2025FARMAMEDICA SA

Guatemala

GUATEMALAVITAMIN B12 (CYANOCOBALAMIN)
75UNAPPROVED
7/3/2025FARMAMEDICA SA

Guatemala

GUATEMALAVITAMIN B6 (PYRIDOXINE)
75UNAPPROVED
7/3/2025Sun Pharma Laboratories Ld

East-Sikkim

INDIASUMATRIPTAN (ANTIMIGRAINE AGENT)
75UNAPPROVED
7/3/2025MSD FRANCE LABORATOY

Puteaux

FRANCEANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
7/3/2025Herbamere/A.Vogel.Bioforce Canada

Pointe-claire

CANADAPASSIONFLOWER (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
7/3/2025Herbamere/A.Vogel.Bioforce Canada

Pointe-claire

CANADANONI (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
7/3/2025Herbamere/A.Vogel.Bioforce Canada

Pointe-claire

CANADAVALERIAN (HERBAL & BOTANICALS, NOT TEAS II)
75UNAPPROVED
7/3/2025Herbamere/A.Vogel.Bioforce Canada

Pointe-claire

CANADAECHINACEA, HERBAL & BOTANICALS (NOT TEAS)
75UNAPPROVED
7/3/2025Laboratorios Quimica Son's, S.A. de C.V

San Andres Cholula

MEXICONUTRIENT/TONIC N.E.C.
75UNAPPROVED
7/3/2025MERK MEXICO SA

NAUCULPCIN

MEXICOANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
7/3/2025ULTRA LABORATORY

Guadalajara

MEXICOOMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
7/3/2025Frezyderm

Athens

GREECEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
7/3/2025Frezyderm

Athens

GREECEULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
7/3/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
7/3/2025ASOFARMA DE MEXICO SA DE CV

Ciudad De Mexic

MEXICOSIMETHICONE (ANTI-FLATULENT)
75UNAPPROVED
7/3/2025Pfizer Manufacturing Belgium NV

Puurs-Sint-Amands

BELGIUMETANERCEPT
75UNAPPROVED
7/3/2025URSAPHARM

Sarreguemines

FRANCEANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
7/3/2025Eli Lilly & Company

Indianapolis

UNITED STATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
7/3/2025TORRENT PHARMACEUTICALS LTD

Uttarakhand

INDIACALCIUM CARBASPIRIN (ANALGESIC)
75UNAPPROVED
7/3/2025Alkem Laboratories Ltd

Mumbai

INDIAIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
7/3/2025CIPLA LIMITED

Mumbai

INDIADIPHENHYDRAMINE HCL (ANTI-HISTAMINIC)
75UNAPPROVED
7/3/2025Macleods Pharmaceuticals Ltd

Mumbai

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
7/3/2025TECHNO PHARM LTD

Kanpur Up

INDIABISACODYL (CATHARTIC)
75UNAPPROVED
7/3/2025Techno Pharma Ltd

Berut Freezone

UNITED ARAA-FUNGAL N.E.C.
75UNAPPROVED
7/3/2025MANKIND PARMA ESTATE

Sahib Sirmour Hp

INDIAITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
7/3/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KORECLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
7/3/2025I.F. CANTABRIA

Santander

SPAINULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
7/3/2025INDUTRIAL FARMACEUTICA CANTABRIAS.A.

Santander

SPAINULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
7/3/2025ZIGN BEAUTY PRIVATE LTD

Bangalore

INDIAFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
7/3/2025HENAN XINYONGTAI MEDICAL TECHNOL

Zhengzhou City

CHINASCOPOLAMINE (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
7/3/2025HARTALEGA NGC SDN BHD

Sepang

MALAYSIAGLOVE, PATIENT EXAMINATION, LATEX
39053905
508NO 510(K)
7/3/2025HANGZHOU PENGTU CHEMICAL FIBER CO.,LTD

Hangzhou

CHINATAMPON, MENSTRUAL, UNSCENTED
39043904
39053905
7/3/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
7/3/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
7/3/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
7/3/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
7/3/2025UNION MEDICO APS

Copenhagen

DENMARKINTRODUCER, SYRINGE NEEDLE
39043904
7/3/2025SILVER STAR RESOURCES CO., INC.

Quezon City

PHILIPPINEBARLEY, WHOLE GRAIN
3887ADDDRUGBIO
7/3/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
7/3/2025Swedish Match North Europe

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB
7/3/2025Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
7/3/2025NGP TOBACCO

Aalborg Sv

DENMARKNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB
7/3/2025NGP TOBACCO

Aalborg Sv

DENMARKNICOTINE DELIVERY PRODUCT, NEC
3854TPLKUSSLLB

About This Page

This page displays 50 FDA import refusal records from 18 countries. Records on this page involve violations including 75 (UNAPPROVED), 3905 (3905), 508 (NO 510(K)), 3904 (3904), 3887 (ADDDRUGBIO) and 1 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 424 of 10,077 • Showing records 21,151-21,200 of 503,850 total