FDA Import Refusals

FDA refused 51,481 shipment lines from 8,855 firms in the year to Oct 23, 2026; 51% were tobacco products, mostly nicotine pouches without a marketing order.

Refused in 12 months: 51,481, as of Oct 23, 2026
In the last 30 days: 7,152
Firms in 12 months: 8,855

Refusals by Country

Where the refused product was made, 12 months to Oct 23, 2026.

Sweden15,78031%
India6,11512%
Denmark4,92710%
China2,8546%
Mexico2,4495%
Poland2,0334%
South Korea1,4793%
Czechia1,2532%
Canada9392%
Guatemala9042%

Refusals by Product Type

From the industry digits of FDA's product code.

Tobacco26,07851%
Foods11,88223%
Drugs8,42816%
Devices3,1306%
Cosmetics1,2112%
Other3871%
Radiation-emitting2160%
Veterinary1020%
Biologics470%

Most Common Charges

A line can carry several. Hover for FDA's wording.

Tobacco product without a marketing order20,67940%
Tobacco product not reported to FDA18,87437%
Unapproved new drug8,59417%
Tobacco label lacks "sale only allowed in the U.S."6,74913%
Drug or device not listed with FDA4,8119%
Maker not registered with FDA3,0586%
Unsafe color additive1,9574%
Filthy, putrid or decomposed1,5773%
Missing nutrition label1,5393%
Label not in English1,5213%

2,000 firm and product groups refused in the 30 days to Oct 23, 2026

Firm	Product	Charges	Refused
ANOTHER SNUS FACTORY STOCKHOLM ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 2026206 lines
YOIK ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 2026195 lines
Snus Fusion Sp. z o.o.Poland	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 2026191 lines
PHILIP MORRIS ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 2026123 lines
TWINROLL SERVICE ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 2026120 lines
NORD SNUS LTDLatvia	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 2026103 lines
FEDRS SP ZOOPoland	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202699 lines
Snusport (Silverton AB)Sweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202695 lines
HOUSE OF POUCHEDenmark	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202691 lines
EMPLICURE CONSUMER ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202682 lines
PHILIP MORRIS ABSweden	NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202664 lines
NGP TOBACCO APSDenmark	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202663 lines
PHILIP MORRIS ABSweden	SNUSTobacco · 98CBA06	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202660 lines
Snusport (Silverton AB)Sweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202660 lines
VONT ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202656 lines
MB EUROLIT EULithuania	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202652 lines
FUTURE360Estonia	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202648 lines
Chainpop Sweden ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202635 lines
PHILIP MORRIS ABSweden	NICOTINE POUCHTobacco · 98NAA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202627 lines
Dholakia Tobacco Pvt LtdIndia	NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99	TPLACKFIRM; Tobacco label lacks "sale only allowed in the U.S."	Oct 23, 202626 lines
ZOTEA TEEHANDEL GMBHSwitzerland	MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VCY99	Unapproved new drug	Oct 23, 202626 lines
STRENGBERGSFinland	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202621 lines
SILVERTON ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202618 lines
HAGA FACTORY ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202618 lines
SMOGENSNUS ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 202617 lines
INSURGENT VENTURES IIIDenmark	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 202616 lines
SMOGENSNUS ABSweden	SMOKELESS TOBACCO POUCHESTobacco · 98CBA16	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202616 lines
Snus Fusion Sp. z o.o.Poland	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 202615 lines
Qingdao Magefy False Eyelash Co., Ltd.China	EYELASH EXTENSIONS-HUMAN HAIR OR SYNTHETIC (OTHER COSMETIC AND COSMETIC PRODUCTS)Cosmetics · 53YY09	HELD INSAN	Oct 23, 202615 lines
LEWA of Sweden ABSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202615 lines
SWEDISH SMOKELESS SOLUTIONSSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 202613 lines
NGP TOBACCO APSDenmark	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 202610 lines
Skruf Snus AbSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202610 lines
PHILIP MORRIS ABSweden	SNUSTobacco · 98CCA06	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202610 lines
ANOTHER SNUS FACTORY STOCKHOLM ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 202610 lines
BRITISH AMERICAN TOBACCOSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 202610 lines
ARKVEDA CLINICIndia	HOMEOPATHIC GASTROINTESTINALDrugs · 66XCY05	Unapproved new drug	Oct 23, 20269 lines
MANTHRAVADI GOURINATHIndia	HOMEOPATHIC N.E.C.Drugs · 66XDY99	Unapproved new drug	Oct 23, 20268 lines
EMPLICURE CONSUMER ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 20267 lines
Cosmetique Active ProductionFrance	ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.Drugs · 66PBY99	Unapproved new drug	Oct 23, 20267 lines
ISH HANDA PRIVATE LIMITEDIndia	HOMEOPATHIC N.E.C.Drugs · 66XDY99	Unapproved new drug	Oct 23, 20266 lines
HS FACTORY SWEDEN ABSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 20266 lines
ALCON VISION, LLC.United States	UNIT, PHACOFRAGMENTATIONDevices · 86HQC	Maker not registered with FDA; Drug or device not listed with FDA	Oct 23, 20266 lines
MANUFACTURER OF KAPZSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 20266 lines
SWEDISH SMOKELESS SOLUTIONSSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco label lacks "sale only allowed in the U.S."	Oct 23, 20266 lines
SETAS GROUP ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 20266 lines
DR. KRUNAL K. SHAHIndia	VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.Foods · 54YFA99	Unapproved new drug	Oct 23, 20265 lines
NGP TOBACCO APSDenmark	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 20265 lines
YAZMIN FRANCO RIVASMexico	PRICKLE PEAR (CORE FRUIT)Foods · 20NFB05	Pesticide residue	Oct 23, 20265 lines
PHILIP MORRIS ABSweden	SNUSTobacco · 98CAA06	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 20265 lines
SQUARE FOOD & BEVERAGE LIMITEDBangladesh	MIXED SPICE AND SEASONINGS, GROUND, CRACKED, WITHOUT SALT, N.E.C.Foods · 28FGT99	Net contents not stated; Label not in English; Missing nutrition label	Oct 23, 20264 lines
FEDRS SP ZOOPoland	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 20264 lines
HARIHAR FOODS PVT LTDIndia	CAPSICUMS (CAYENNE CHILI, HOT PEPPERS), GROUND, CRACKED (SPICE)Foods · 28BGT08	Salmonella	Oct 23, 20264 lines
LEWA of Sweden ABSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 20264 lines
KRM AYURVEDA PVT LTDIndia	MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VIY99	Maker not registered with FDA; Drug or device not listed with FDA; Unapproved new drug	Oct 23, 20264 lines
MB EUROLIT EULithuania	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 20263 lines
Merck, S.A. de C.V.Mexico	DICLOFENAC SODIUM (ANTI-INFLAMMATORY)Drugs · 62GDA18	Unapproved new drug	Oct 23, 20263 lines
Cosmax IncSouth Korea	OTHER SKIN CARE PREPARATIONS, N.E.C.Cosmetics · 53LD99	CSTIC LBLG	Oct 23, 20263 lines
EXPORTADORA SERAFINO, C POR A.Dominican Republic	PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)Foods · 24FFC08	Pesticide residue	Oct 23, 20263 lines
POSITIVE HERBS CARE PVT LTDIndia	HOMEOPATHIC N.E.C.Drugs · 66XDY99	Unapproved new drug	Oct 23, 20263 lines
HAGA FACTORY ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 20263 lines
GLOBAL SNUS UABLithuania	NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99	Tobacco product without a marketing order	Oct 23, 20263 lines
Alcon Research, LTD.United States	UNIT, PHACOFRAGMENTATIONDevices · 86HQC	Maker not registered with FDA; Drug or device not listed with FDA	Oct 23, 20263 lines
POSITIVE HERBS CARE PVT LTDIndia	MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VDY99	Unapproved new drug	Oct 23, 20263 lines
CONSUMER BRANDS INTERNATIONALCzechia	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 20262 lines
YOIK ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 20262 lines
L'OrealFrance	OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.Cosmetics · 53ED99	Unapproved new drug	Oct 23, 20262 lines
WEIFANG JIANGDA FOOD CO.,LTDChina	GINGER ROOT (ROOT & TUBER VEGETABLE)Foods · 25JYC24	Importer breaks foreign supplier rules	Oct 23, 20262 lines
BOEHRINGER INGELHEIM INDIA PVTIndia	LINAGLIPTIN (ANTI-DIABETIC)Drugs · 61PCA66	Drug or device not listed with FDA; Unapproved new drug	Oct 23, 20262 lines
Moctezuma Medjool GardensMexico	DATES (PIT FRUIT), (PIT FRUIT)Foods · 21GFC05	Filthy, putrid or decomposed	Oct 23, 20262 lines
DR. MANKADS HOMEOCLINICIndia	HOMEOPATHIC N.E.C.Drugs · 66XCA99	Unapproved new drug	Oct 23, 20262 lines
DR. KRUNAL K. SHAHIndia	VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.Foods · 54YGA99	Unapproved new drug	Oct 23, 20262 lines
Hangzhou Dingyi Food Co., Ltd.China	POTATO CHIPS,FRIEDFoods · 07BGT06	LACKS FIRM; Net contents not stated; Label not in English; PRESRV LBL; USUAL NAME	Oct 23, 20262 lines
EKAI ELECTRONIC TECHNOLOGY CO LTChina	IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USEDevices · 79LMH	INCONSPICU; RXPERSONAL; STAFRNMFGA; STANOENG A; STANOPMA A; STANOTLI A	Oct 23, 20262 lines
MANKIND PHARMA LTDIndia	SILDENAFIL CITRATE (REGULATOR)Drugs · 65PCA02	Drug or device not listed with FDA; Unapproved new drug	Oct 23, 20262 lines
Glenmark Pharmaceuticals LimitedIndia	TELMISARTAN (ANTI-HYPERTENSIVE - PART II)Drugs · 62ODY09	Drug made outside good manufacturing practice	Oct 23, 20262 lines
POSITIVE HERBS CARE PVT LTDIndia	HOMEOPATHIC N.E.C.Drugs · 66XCY99	Unapproved new drug	Oct 23, 20262 lines
RAPTAKOS BRETT AND COMPANY LIMITEDIndia	PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.Foods · 03HGT99	ALLERGEN; Ingredients not listed; Missing nutrition label; USUAL NAME	Oct 23, 20262 lines
SQUARE FOOD & BEVERAGE LIMITEDBangladesh	MIXED SPICE AND SEASONINGS, GROUND, CRACKED, WITHOUT SALT, N.E.C.Foods · 28FGT99	Net contents not stated; Ingredients not listed; Label not in English; Missing nutrition label	Oct 23, 20262 lines
SUN PHARMAIndia	ANTI-CHOLESTEREMIC, N.E.C.Drugs · 61JDA99	Unapproved new drug	Oct 23, 20262 lines
Heintz Van LandewyckLuxembourg	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA; Tobacco label lacks "sale only allowed in the U.S."; TPNOWRNLBL	Oct 23, 20262 lines
MERZ PHARMAUnited Kingdom	OTHER SKIN CARE PREPARATIONS, N.E.C.Cosmetics · 53LY99	NO PMA; Unapproved new drug	Oct 23, 20262 lines
TIN JAR NICCO DOME (TIN JAR AB)Sweden	SNUSTobacco · 98CBA06	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 20262 lines
Bubs GodisSweden	CANDY WITHOUT CHOCOLATE N.E.C.Foods · 33YYY99	Color additive labeling; Unsafe color additive	Oct 23, 20262 lines
NORD SNUS LTDLatvia	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 20262 lines
FUTURE360Estonia	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 20262 lines
LABORATORIOS NORVET SA DE CVMexico	FUROSEMIDE (DIURETIC)Drugs · 64BQC24	Unapproved new drug	Oct 23, 2026
ISH HANDAIndia	ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)Foods · 54FFE94	Unapproved new drug	Oct 23, 2026
Cipla Pvt LtdIndia	FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)Drugs · 61WCB45	Unapproved new drug	Oct 23, 2026
SIGMA IOTA RA MATRIUnited Kingdom	DEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIESDevices · 79GEI	Maker not registered with FDA	Oct 23, 2026
VASQUEZ LOPEZ EDGAR VINICIOEcuador	CHEESE, HISPANIC/LATINO/MEXICAN STYLE, ALL VARIETIES, INCLUDING QUESOFoods · 12CGT13	Poisonous or harmful substance	Oct 23, 2026
Alkem Laboratories Ltd., Bioequivalence CentreIndia	VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.Foods · 54YGY99	Unapproved new drug	Oct 23, 2026
Agusto Formulations, Pvt. Ltd.India	CHYMOTRYPSIN (ENZYME)Drugs · 64EDA11	Drug or device not listed with FDA; Unapproved new drug	Oct 23, 2026
GUFIC LTDIndia	LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)Drugs · 62KCA08	Unapproved new drug	Oct 23, 2026
Somafaco, SAMorocco	DRIED SOUP, N.E.C.Foods · 38CFT99	Ingredients not listed; Unsafe color additive	Oct 23, 2026
Kendal Nutricare Ltd.United Kingdom	MILK BASE INFANT FORMULA PRODUCT (0-12 MONTHS), POWDER FORMULAFoods · 40PYB01	FALSE	Oct 23, 2026
MARGAFRIQUEMorocco	CHEESE AND CHEESE PRODUCTS, NOT ELSEWHERE MENTIONED, N.E.C.Foods · 12YFT99	Ingredients not listed; USUAL NAME	Oct 23, 2026
USV Private LimitedIndia	METFORMIN HCL (ANTI-DIABETIC)Drugs · 61PCY55	Unapproved new drug	Oct 23, 2026
ISH HANDAIndia	HOMEOPATHIC N.E.C.Drugs · 66XCJ99	Unapproved new drug	Oct 23, 2026
ECONOMY EXPRESSHonduras	TAMARIND (SUBTROPICAL AND TROPICAL FRUIT)Foods · 21SYY14	Filthy, putrid or decomposed	Oct 23, 2026
JANNAT BEAUTY INSTRUMENTSPakistan	RETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERYDevices · 79GAD	DE IMP GMP	Oct 23, 2026
POSITIVE HERBS CARE PVT LTDIndia	HERBALS & BOTANICALS (NOT TEAS), N.E.C.Foods · 54FGY99	Unapproved new drug	Oct 23, 2026
Emcure PharmaceuticalsIndia	DOLUTEGRAVIR SODIUM (ANTI-VIRAL)Drugs · 62VDA73	Unapproved new drug	Oct 23, 2026
NALYA-PHARM, SRLMoldova	MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)Foods · 54ACH90	LACKS FIRM; NCONTACT; Missing nutrition label	Oct 23, 2026
SJM COSMETIC CO., LTDSouth Korea	PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)Cosmetics · 53LD08	Label statement placement	Oct 23, 2026
FUTURE360Estonia	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 2026
RECORDATI POLSKAPoland	TRIBENOSIDE (SCLEROSING AGENT)Drugs · 65UAA02	Unapproved new drug	Oct 23, 2026
Snus Fusion Sp. z o.o.Poland	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 2026
DR. MANKADS HOMEOCLINICIndia	HOMEOPATHIC N.E.C.Drugs · 66XCK99	Unapproved new drug	Oct 23, 2026
GUANGZHOU PLUSLIFE BIOTECH CO LTChina	COVID-19 TEST HOME COLLECTION KIT DEVICESDevices · 83QLW	Maker not registered with FDA; Drug or device not listed with FDA	Oct 23, 2026
SUN PHARMACEUTICALS IND LTDIndia	GLIMEPIRIDE (ANTI-DIABETIC)Drugs · 61PDA31	Unapproved new drug	Oct 23, 2026
SHENZHEN MOBI FUTURE INNOVATIONTECHNOLOGY CO., LTDChina	WHEELCHAIR, POWEREDDevices · 89ITI	NO REGISTR	Oct 23, 2026
NALYA-PHARM, SRLMoldova	VITAMIN B12 (CYANOCOBALAMIN)Foods · 54ACH05	LACKS FIRM; NCONTACT; Missing nutrition label	Oct 23, 2026
LABARATORY BAYERBrazil	ESTRADIOL VALERATE (ESTROGEN)Drugs · 64GCA13	Unapproved new drug	Oct 23, 2026
Snusport (Silverton AB)Sweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 2026
SUN PHARMAIndia	GLIMEPIRIDE (ANTI-DIABETIC)Drugs · 61PDA31	Unapproved new drug	Oct 23, 2026
STERLING LABIndia	DOXYCYCLINE (TETRACYCLINES)Drugs · 56EDF20	Unapproved new drug	Oct 23, 2026
TORRENT DO BRAZILBrazil	SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)Drugs · 61NCA78	Unapproved new drug	Oct 23, 2026
CORPORACION DINANT S.A. DE CVHonduras	PLANTAIN SNACKS, FRUIT SNACK FOODS, FRIED/OIL COOKEDFoods · 07HFT04	Ingredients not listed	Oct 23, 2026
BRITISH AMERICAN TOBACCOSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 2026
ISH HANDAIndia	HOMEOPATHIC N.E.C.Drugs · 66XCE99	Unapproved new drug	Oct 23, 2026
SHAANXI LONIERHERB BIO-TECHNOLOGChina	MEBENDAZOLE (ANTHELMINTIC)Drugs · 60WCE16	Unapproved new drug	Oct 23, 2026
MCNEIL HEALTHCARE (IRELAND) LTDIreland	BUDESONIDE (ANTI-ASTHMATIC)Drugs · 61EAY04	Unapproved new drug	Oct 23, 2026
BORRAS S.L. DE P.A.Spain	COOKIE,BISCUIT,WAFER DOUGH, N.E.C.Foods · 03MFT99	FALSE; Ingredients not listed	Oct 23, 2026
LUMI EL SALVADOR S.A.El Salvador	HARD CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE)Foods · 33CFT99	Filthy, putrid or decomposed	Oct 23, 2026
Prollenium Medical Technologies Inc.Canada	IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USEDevices · 79LMH	Device without 510(k) clearance	Oct 23, 2026
INDIAN HERBO PHARMAIndia	HOMEOPATHIC N.E.C.Drugs · 66XDA99	Drug or device not listed with FDA; Unapproved new drug	Oct 23, 2026
HARIHAR FOODS PVT LTDIndia	PEPPER,BLACK, WHOLE (SPICE)Foods · 28AGT54	Filthy, putrid or decomposed; Salmonella	Oct 23, 2026
Sanofi India LtdIndia	FEXOFENADINE HCL (ANTI-ASTHMATIC)Drugs · 61ECY06	Unapproved new drug	Oct 23, 2026
IMPERIAL BRANDSSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 2026
SMART LABORATORIES PVTIndia	AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)Drugs · 56BCY03	Unapproved new drug	Oct 23, 2026
RAPTAKOS, BRETT & CO LTDIndia	PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.Foods · 03HGT99	ALLERGEN; Ingredients not listed; Missing nutrition label; USUAL NAME	Oct 23, 2026
JUVEDERMFrance	OTHER SKIN CARE PREPARATIONS, N.E.C.Cosmetics · 53LY99	NO PMA; Unapproved new drug	Oct 23, 2026
MESTRA LTDIndia	MONTELUKAST SODIUM (ANTI-ASTHMATIC)Drugs · 61EDA09	Unapproved new drug	Oct 23, 2026
HOUSE OF POUCHEDenmark	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 2026
SHENZHEN HUGEMED MEDICAL TECHNICChina	LARYNGOSCOPE, RIGIDDevices · 73CCW	Maker not registered with FDA; Drug or device not listed with FDA; Device distributor not registered	Oct 23, 2026
CP Gaba GmbhGermany	SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RAL04	Maker not registered with FDA; Drug or device not listed with FDA	Oct 23, 2026
LEVV GROUP OUEstonia	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 2026
Makson Health Care Private Ltd.India	MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VBJ99	Unapproved new drug	Oct 23, 2026
SIAM MACRO PUBLIC COMPANY LIMITEThailand	TAMARIND, DRIED OR PASTEFoods · 21TYT14	Filthy, putrid or decomposed	Oct 23, 2026
Teoxane S.A.Switzerland	IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USEDevices · 79LMH	Device without 510(k) clearance	Oct 23, 2026
Swizzels Matlow LimitedUnited Kingdom	CANDY WITHOUT CHOCOLATE N.E.C.Foods · 33YYY99	Unsafe color additive	Oct 23, 2026
ONECARE WELLNESS SDN BHDMalaysia	VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.Foods · 54YCY99	Unapproved new drug	Oct 23, 2026
NINGBO HAITIAN HOLDING GROUP CO LTDChina	OXIMETERDevices · 73DQA	Maker not registered with FDA	Oct 23, 2026
Daewoong Pharmaceutical Co. , LtdSouth Korea	ONABOTULINUMTOXINAOther · 58PDZ05	708NEWDR A	Oct 23, 2026
SQUARE FOOD & BEVERAGE LIMITEDBangladesh	MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS, N.E.C.Foods · 37BGT99	Color additive labeling; Net contents not stated; Ingredients not listed; Label not in English; Missing nutrition label; Unsafe color additive	Oct 23, 2026
Laboratorios PiersanGuatemala	ACYCLOVIR (ANTI-VIRAL)Drugs · 62VDY18	Unapproved new drug	Oct 23, 2026
Hangzhou Dingyi Food Co., Ltd.China	POTATO CHIPS,FRIEDFoods · 07BGT06	ALLERGEN; LACKS FIRM; Net contents not stated; Label not in English; PRESRV LBL; USUAL NAME	Oct 23, 2026
GLUCO RX LTDUnited Kingdom	SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTERDevices · 75NBW	Maker not registered with FDA; Device without 510(k) clearance; Drug or device not listed with FDA	Oct 23, 2026
OCEAN OPTICALSIndia	SPECTACLE, MAGNIFYINGDevices · 86HOI	Maker not registered with FDA; Drug or device not listed with FDA; RX DEVICE	Oct 23, 2026
PRP Science Co., LtdSouth Korea	IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USEDevices · 79LMH	STADIRCT A; STANOENG A	Oct 23, 2026
SUN PHARMAIndia	LEVETIRACETAM (ANTI-CONVULSANT)Drugs · 61MCA42	Drug or device not listed with FDA; Unapproved new drug	Oct 23, 2026
OCEAN OPTICALSIndia	LENSES, SOFT CONTACT, DAILY WEARDevices · 86LPL	RX DEVICE; STAFRNMFGA; STANO510 A; STANOTLI A	Oct 23, 2026
Ursapharm Arzneimittel GmbHGermany	MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VBK99	Unapproved new drug	Oct 23, 2026
SM PHARMA AND LABORATORIES LTDIndia	ESCITALOPRAM OXALATEDrugs · 61NDA83	Unapproved new drug	Oct 23, 2026
Prollenium Medical Technologies Inc.Canada	WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)Cosmetics · 53LF10	CSTIC LBLG	Oct 23, 2026
JAMP PHARMACanada	VALACYCLOVIR HCL (ANTI-VIRAL)Drugs · 62VDA42	Unapproved new drug	Oct 23, 2026
NEW RAY PHARMACEUTICALS PVT LTDIndia	MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VDY99	Unapproved new drug	Oct 23, 2026
HARIHAR FOODS PVT LTDIndia	CARBONATED SOFT DRINK, N.E.C.Foods · 29BCT99	Filthy, putrid or decomposed	Oct 23, 2026
LUCIA ROSAS MENDOZAMexico	CABBAGE (LEAF & STEM VEGETABLE)Foods · 24TFC08	Pesticide residue	Oct 23, 2026
SUN PHARMAIndia	ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)Drugs · 61JCY08	Unapproved new drug	Oct 23, 2026
PMKMXMexico	ACETAMINOPHEN (ANALGESIC)Drugs · 60LCC01	Drug or device not listed with FDA; Unapproved new drug	Oct 23, 2026
THE SNUS BROTHERSSweden	NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 2026
GUANG DONG LMJ LIGHTING CO., LTDChina	LASER MARKER OR ENGRAVERRadiation-emitting · 95RHK	NON STD	Oct 23, 2026
PMKMXMexico	CLINDAMYCIN HYDROCHLORIDE HYDRATE (LINCOMYCINS)Drugs · 56JCC20	Drug or device not listed with FDA; Unapproved new drug	Oct 23, 2026
COMEM NATURAL JSCVietnam	OTHER SKIN CARE PREPARATIONS, N.E.C.Cosmetics · 53LD99	Drug or device not listed with FDA	Oct 23, 2026
RAVENBHEI BIOTECHIndia	ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)Drugs · 62TDE06	Unapproved new drug	Oct 23, 2026
SUNDAYOTA NUMANDIS PROBIOCEUTICAIndia	PROBIOTICS (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)Foods · 54YGY20	Unapproved new drug	Oct 23, 2026
MARGAFRIQUEMorocco	FILLED MILK, CHEESE TYPE PRODUCTFoods · 14AFY04	Ingredients not listed; USUAL NAME	Oct 23, 2026
SMART LABORATORIES PVTIndia	KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)Drugs · 61WDY47	Unapproved new drug	Oct 23, 2026
PURE AND CURE HEALTHCAREIndia	VITAMIN, N.E.C.Foods · 54AGA99	Unapproved new drug	Oct 23, 2026
ALKEM LTDIndia	VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.Foods · 54YGY99	Unapproved new drug	Oct 23, 2026
PRATI DONADUZZI LTDABrazil	IBUPROFEN (ANTI-INFLAMMATORY)Drugs · 62GCY41	Unapproved new drug	Oct 23, 2026
ISH HANDAIndia	HOMEOPATHIC N.E.C.Drugs · 66XDE99	Unapproved new drug	Oct 23, 2026
LIBBSBrazil	DROSPIRENONEDrugs · 65JDY39	Unapproved new drug	Oct 23, 2026
FABAMED COSMETIC AND MACHINERYTürkiye	PEPTIDE N.E.C.Drugs · 56FCZ99	INCONSPICU; Net contents not stated; PERSONALRX; Unapproved new drug	Oct 23, 2026
SHIVALIK REMEDIESIndia	ANTI-INFLAMMATORY N.E.C.Drugs · 62GDY99	Unapproved new drug	Oct 23, 2026
CIPLA LTDIndia	OXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)Drugs · 66NDA07	Unapproved new drug	Oct 23, 2026
CORPORACION DEL VALLE METROPOLITANO S.A.Costa Rica	GEL CUPS, FRUIT FLAVOREDFoods · 33MGT01	UNFIT4FOOD	Oct 23, 2026
WINLIFE PHARMAIndia	IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)Drugs · 62LCA47	Unapproved new drug	Oct 23, 2026
HANDA HEALTHCARE CENTERIndia	HOMEOPATHIC N.E.C.Drugs · 66XDA99	Drug or device not listed with FDA; Unapproved new drug	Oct 23, 2026
RECKITT BENCKISER INDIA PVT LTDIndia	ALUMINUM HYDROXIDE (ANTACID)Drugs · 60SDY04	Unapproved new drug	Oct 23, 2026
SUN PHARMAIndia	ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)Drugs · 62TCY06	Unapproved new drug	Oct 23, 2026
Cipla LimitedIndia	NORFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)Drugs · 61GCA84	Unapproved new drug	Oct 23, 2026
VYAS PHARMACEUTICALSIndia	HOMEOPATHIC N.E.C.Drugs · 66XDA99	Drug or device not listed with FDA; Unapproved new drug	Oct 23, 2026
DR REDDYS LABORATORIE LTDIndia	RABEPRAZOLE SODIUM (ANTACID) (ANTI-ULCER)Drugs · 60SDY27	Unapproved new drug	Oct 23, 2026
DR REDDYS LABORATORIES LTDIndia	ECONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC)Drugs · 61WCJ44	Unapproved new drug	Oct 23, 2026
ABU RAKAN AL ABSI COMMERCIAL ENTJordan	CARBONATED SOFT DRINK, N.E.C.Foods · 29BCT99	Label not in English; Unsafe color additive	Oct 23, 2026
SILVERTON ABSweden	SMOKELESS TOBACCO POUCHESTobacco · 98CDA16	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 2026
Levant Food Products Company Ltd.Jordan	SESAME SEED (EDIBLE SEED PASTE)Foods · 23RGT02	FALSE; INADPRCCTL; Missing nutrition label; Salmonella	Oct 23, 2026
VAPI CARE PHARMA PVT LTDIndia	METFORMIN (ANTI-DIABETIC)Drugs · 61PDY26	Unapproved new drug	Oct 23, 2026
IDT Biologika GmbHGermany	FERRIC MALTOL (ANTI-ANEMIC)Drugs · 61CDP11	Unapproved new drug	Oct 23, 2026
SBL Private LimitedIndia	HOMEOPATHIC N.E.C.Drugs · 66XAY99	Unapproved new drug	Oct 23, 2026
Jordan Ice Aerated Water Co.Jordan	CARBONATED SOFT DRINK, N.E.C.Foods · 29BCT99	Label statement placement; Label not in English; Missing nutrition label; Unsafe color additive	Oct 23, 2026
ACHE LABORATORIOS FARMACEUTICOSBrazil	ETHINYL ESTRADIOL (ESTROGEN)Drugs · 64GDY19	Unapproved new drug	Oct 23, 2026
MESTRA LTDIndia	ANTI-INFLAMMATORY N.E.C.Drugs · 62GDA99	Unapproved new drug	Oct 23, 2026
Cosmax IncSouth Korea	WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)Cosmetics · 53LF10	CSTIC LBLG	Oct 23, 2026
TOGO NICOTINE ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 2026
BOEHRINGER INGELHEIM PROMECO S.A. de C.V.Mexico	FUROSEMIDE (DIURETIC)Drugs · 64BQC24	Unapproved new drug	Oct 23, 2026
ISH HANDAIndia	LEVOCARNITINE (NUTRIENT/TONIC)Drugs · 65CCE07	Unapproved new drug	Oct 23, 2026
WALTER LTDIndia	MEFENAMIC ACID (ANTI-INFLAMMATORY)Drugs · 62GDA48	Unapproved new drug	Oct 23, 2026
EXEMED PHARMACEUTICALSIndia	ANTI-HISTAMINIC N.E.C.Drugs · 61XCY99	Unapproved new drug	Oct 23, 2026
NEW RAY PHARMACEUTICALS PVT LTDIndia	NALTREXONE (ANTAGONIST)Drugs · 60TCC15	Unapproved new drug	Oct 23, 2026
KARMA AYURVEDAIndia	MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VIY99	Maker not registered with FDA; Drug or device not listed with FDA; Unapproved new drug	Oct 23, 2026
HIMALAYA WELLNESS COMPANYIndia	HOMEOPATHIC N.E.C.Drugs · 66XDA99	Drug or device not listed with FDA; Unapproved new drug	Oct 23, 2026
SANTOZ SURGICAL INSTRUMENTSPakistan	STAPLER, SURGICALDevices · 79GAG	Maker not registered with FDA; Device without 510(k) clearance; Drug or device not listed with FDA; Device distributor not registered	Oct 23, 2026
Ursapharm Arzneimittel GmbHGermany	MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VBY99	Unapproved new drug	Oct 23, 2026
ALKEM LABRATORIES LTDIndia	CLINDAMYCIN PHOSPHATE (LINCOMYCINS)Drugs · 56JCY31	Unapproved new drug	Oct 23, 2026
Daehan Pharmaceutical Industry Co., LtdSouth Korea	SODIUM CHLORIDE (REPLENISHER)Drugs · 65RCK19	Label not in English; Unapproved new drug	Oct 23, 2026
LEVV GROUP OUEstonia	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 2026
Conkin Surgical Instruments Ltd.Canada	ELEVATOR, UTERINEDevices · 85HDP	Device without 510(k) clearance; Device distributor not registered	Oct 23, 2026
HOUSE OF POUCHEDenmark	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 23, 2026
cadbury nigeria plcNigeria	CANDY WITHOUT CHOCOLATE N.E.C.Foods · 33YYT99	Unsafe color additive	Oct 23, 2026
Vidora Farmaceutica LTDA.Brazil	SIMETHICONE (ANTI-FLATULENT)Drugs · 61VCY01	Unapproved new drug	Oct 23, 2026
STRENGBERGSFinland	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 2026
U.SK UNDER SKINBrazil	NITAZOXANIDEDrugs · 62KCY11	Unapproved new drug	Oct 23, 2026
Premium Pouch Finland OYFinland	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 2026
LA CONFISERIE CANDYLABSCanada	HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)Foods · 33EYY99	Color additive labeling; Label not in English	Oct 23, 2026
NOVARTISBrazil	TOBRAMYCIN SULFATE (AMINOGLYCOSIDES)Drugs · 56DCO80	Unapproved new drug	Oct 23, 2026
Bayer AGGermany	CYPROTERONE ACETATE (ANTI-ANDROGEN)Drugs · 61BDY02	Unapproved new drug	Oct 23, 2026
LEWA of Sweden ABSweden	SMOKELESS TOBACCO POUCHESTobacco · 98CEA16	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 23, 2026
SQUARE FOOD & BEVERAGE LIMITEDBangladesh	MIXED SPICE AND SEASONINGS, GROUND, CRACKED, WITHOUT SALT, N.E.C.Foods · 28FGT99	ALLERGEN; Net contents not stated; Label not in English; Missing nutrition label	Oct 23, 2026
Coooper Vision ItaliaItaly	SYSTEM, IN-OFFICE TINTING, CONTACT LENSESDevices · 86MZD	Maker not registered with FDA; Device without 510(k) clearance; Drug or device not listed with FDA; Device distributor not registered	Oct 23, 2026
GLENMARK PHARMACEUTICALS LTDIndia	CLOTRIMAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)Drugs · 61WCY04	Unapproved new drug	Oct 23, 2026
CIPLA LTDIndia	AZITHROMYCIN (MACAROLIDES)Drugs · 56ICY76	Unapproved new drug	Oct 23, 2026
ERIS THERAPEUTICS LTDIndia	BENZOYL PEROXIDE (KERATOLYTIC)Drugs · 64XCJ03	Unapproved new drug	Oct 23, 2026
EKAI ELECTRONIC TECHNOLOGY CO LTChina	POWERED MICRONEEDLE DEVICEDevices · 79QAI	Maker not registered with FDA; NO PMA; Drug or device not listed with FDA; Device distributor not registered	Oct 23, 2026
SANOFY MEDLEY FARMACEUTICA LTDABrazil	TRAZODONE HCL (ANTI-DEPRESSANT)Drugs · 61NCY60	Unapproved new drug	Oct 23, 2026
MEDPLUS LTDIndia	CLOBAZAM (TRANQUILIZER)Drugs · 66MCA78	Drug or device not listed with FDA; Unapproved new drug	Oct 23, 2026
ACHE LABORATORIOS FARMACEUTICOSBrazil	SUPPRESSANT N.E.C.Drugs · 66FDY99	Unapproved new drug	Oct 23, 2026
Merck, S.A. de C.V.Mexico	DICLOFENAC SODIUM (ANTI-INFLAMMATORY)Drugs · 62GDY18	Unapproved new drug	Oct 23, 2026
COSWELL SPAItaly	STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)Drugs · 63RAJ06	Maker not registered with FDA; Drug or device not listed with FDA	Oct 23, 2026
NATCO PHARMA LTDIndia	SOFOSBUVIR (ANTI-VIRAL)Drugs · 62VDA86	Unapproved new drug	Oct 23, 2026
DAEWOONG PHARMACEUTICAL CO LTDSouth Korea	ONABOTULINUMTOXINAOther · 58PCZ05	708NEWDR A; 708NOENG A	Oct 23, 2026
JTI SWEDEN ABSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order	Oct 23, 2026
SWEDISH SMOKELESS SOLUTIONSSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 2026301 lines
INSURGENT VENTURES IIIDenmark	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 2026261 lines
HS FACTORY SWEDEN ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 2026189 lines
SWEDISH SMOKELESS SOLUTIONSSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 2026147 lines
NGP TOBACCO APSDenmark	NICOTINE POUCHTobacco · 98NCA11	Tobacco label lacks "sale only allowed in the U.S."	Oct 22, 2026118 lines
HS FACTORY SWEDEN ABSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 202664 lines
TWINROLL SERVICE ABSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco label lacks "sale only allowed in the U.S."	Oct 22, 202651 lines
FUTURE360Estonia	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 202647 lines
MANUFACTURER OF KAPZSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 202638 lines
CONSUMER BRANDS INTERNATIONALCzechia	NICOTINE POUCHTobacco · 98NCA11	TPLACKFIRM; Tobacco label lacks "sale only allowed in the U.S."	Oct 22, 202635 lines
YOIK ABSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 202625 lines
WIJO POUCHES ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 202625 lines
PHILIP MORRIS ABSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 202624 lines
LEVV GROUP OUEstonia	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 202622 lines
HAGA FACTORY ABSweden	NICOTINE POUCHTobacco · 98NBA11	TPLACKFIRM; Tobacco label lacks "sale only allowed in the U.S."	Oct 22, 202619 lines
Luna CorporatePoland	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 202616 lines
Dholakia Tobacco Pvt LtdIndia	NICOTINE DELIVERY PRODUCT, NECTobacco · 98NCA99	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 202613 lines
Dholakia Tobacco Pvt LtdIndia	NICOTINE POUCHTobacco · 98NCA11	Tobacco label lacks "sale only allowed in the U.S."	Oct 22, 202610 lines
STRENGBERGSFinland	NICOTINE POUCHTobacco · 98NCA11	Tobacco label lacks "sale only allowed in the U.S."	Oct 22, 20268 lines
Dholakia Tobacco Pvt LtdIndia	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 20267 lines
Life PharmaAfghanistan	RAISINS, DRIED OR PASTEFoods · 20BGT10	Pesticide residue	Oct 22, 20265 lines
Qingdao Magefy False Eyelash Co., Ltd.China	EYELASH EXTENSIONS-HUMAN HAIR OR SYNTHETIC (OTHER COSMETIC AND COSMETIC PRODUCTS)Cosmetics · 53YY09	FILTH; HELD INSAN	Oct 22, 20265 lines
LEWA of Sweden ABSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 20265 lines
Chainpop Sweden ABSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 20264 lines
PHILIP MORRIS ABSweden	NICOTINE DELIVERY PRODUCT, NECTobacco · 98NBA99	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 20264 lines
IMPERIAL BRANDSSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 20263 lines
Mount Kailash Rejuvenation Centre Inc.St. Lucia	VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.Foods · 54YCH99	PLANT PART; Unapproved new drug	Oct 22, 20263 lines
Across Co., LtdSouth Korea	IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USEDevices · 79LMH	Maker not registered with FDA; NO PMA; Drug or device not listed with FDA; Device distributor not registered	Oct 22, 20263 lines
Kettenbach GmbH & Co. KGGermany	MATERIAL, IMPRESSIONDevices · 76ELW	Device without 510(k) clearance; Drug or device not listed with FDA	Oct 22, 20262 lines
Swedish Match AbSweden	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 20262 lines
Allergan Pharmaceuticals Trade Co.Türkiye	ONABOTULINUMTOXINAOther · 58PDZ05	Unapproved new drug	Oct 22, 20262 lines
Bubs GodisSweden	MARSHMALLOW CANDY, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)Foods · 33LGT09	Color additive labeling; Unsafe color additive	Oct 22, 20262 lines
SILVERTON ABSweden	SMOKELESS TOBACCO POUCHESTobacco · 98CCA16	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 20262 lines
Dongbang Medical Co. LtdSouth Korea	IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USEDevices · 79LMH	Maker not registered with FDA; NO PMA; Drug or device not listed with FDA; Device distributor not registered	Oct 22, 20262 lines
BOTU LONGSHENG FRUIT CO LTDChina	CHINESE RED DATE (JUJUBES, ZIZIPHUS JUJUBA) (PIT FRUIT)Foods · 21GGC16	Filthy, putrid or decomposed	Oct 22, 20262 lines
QINGDAO MAGIC FALSE EYELASHES CO., LTD.China	EYELASH EXTENSIONS-HUMAN HAIR OR SYNTHETIC (OTHER COSMETIC AND COSMETIC PRODUCTS)Cosmetics · 53YY09	HELD INSAN	Oct 22, 20262 lines
Philipip Morris IntlSwitzerland	NICOTINE POUCHTobacco · 98NBA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 20262 lines
Exocobio, Inc.South Korea	IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USEDevices · 79LMH	STAFRNMFGA; STANOPMA A; STANOTLI A	Oct 22, 20262 lines
SJM COSMETIC CO., LTDSouth Korea	PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)Cosmetics · 53LF08	CSTIC LBLG	Oct 22, 20262 lines
HUGEL CO LTDSouth Korea	ONABOTULINUMTOXINAOther · 58PCK05	708LIST A; 708NOENG A; 708NOREG A; 708NORX A	Oct 22, 20262 lines
DAEHAN NEW PHARMSouth Korea	SODIUM CHLORIDE (REPLENISHER)Drugs · 65RCK19	DIRSEXMPT; Maker not registered with FDA; Label not in English; Drug or device not listed with FDA; Unapproved new drug	Oct 22, 2026
HASCO VISION TECHNOLOGY CO., LTD.China	LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTSRadiation-emitting · 95RFE	NO REGISTR	Oct 22, 2026
JEIL TECH CO LTDSouth Korea	NEEDLE, ACUPUNCTURE, SINGLE USEDevices · 80MQX	Maker not registered with FDA; Device without 510(k) clearance; Drug or device not listed with FDA	Oct 22, 2026
Ningbo J&S Botanics Inc.China	GINSENG UNCONVENTIONAL DIETARY SPECIALITY FOR HUMANS OR ANIMALSFoods · 54YBR04	SBGINSENG	Oct 22, 2026
LIVKON PHARMACEUTICALS PRIVATE LIndia	VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.Foods · 54YCY99	FALSE	Oct 22, 2026
Oak K.K., CorporationJapan	MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22')Foods · 16AGT73	MFRHACCP	Oct 22, 2026
TJP LABSCanada	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order	Oct 22, 2026
DAVID HELATH VIETNAM JOINT STOCKVietnam	FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERSFoods · 41BYY99	Label not in English	Oct 22, 2026
Ursapharm Arzneimittel GmbHGermany	SOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYEDevices · 86MSI	Device without 510(k) clearance	Oct 22, 2026
A.E.C.CANNING CO.Thailand	TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)Foods · 16AEE45	HISTAMINE; Missing nutrition label	Oct 22, 2026
Chemometec AsDenmark	COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)Devices · 81GKL	Drug or device not listed with FDA; Device distributor not registered	Oct 22, 2026
JETEMA CO LTDSouth Korea	IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USEDevices · 79LMH	STAFRNMFGA; STANOPMA A; STANOTLI A	Oct 22, 2026
Adrian Santiago RomeroMexico	CANDY WITHOUT CHOCOLATE N.E.C.Foods · 33YGT99	Filthy, putrid or decomposed	Oct 22, 2026
ROUSSEL JEANFrance	PAROXETINE (ANTI-DEPRESSANT)Drugs · 61NCY76	Unapproved new drug	Oct 22, 2026
SID MEDICOS CO LTDSouth Korea	CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)Cosmetics · 53LD01	Unapproved new drug	Oct 22, 2026
ARAMEX- TRANSITUnited Kingdom	AZELAIC ACID (ANTI-SEBORRHEIC)Drugs · 62SCY03	Maker not registered with FDA; Drug or device not listed with FDA	Oct 22, 2026
SANOFI WINTHROP INDUSTRIE S.A.France	IRBESARTAN (ANTI-HYPERTENSIVE - PART II)Drugs · 62OCC37	Unapproved new drug	Oct 22, 2026
FPT LONG CHAU PHARMA JOINT STOCKVietnam	FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERSFoods · 41BYY99	Label not in English	Oct 22, 2026
RADIENT PHARMAIndia	HOMEOPATHIC DERMATOLOGICALDrugs · 66XBY04	Unapproved new drug	Oct 22, 2026
Ushas Nigerian ServicesNigeria	TILAPIAFoods · 16AJH58	Insanitary conditions, may be injurious; Made under insanitary conditions	Oct 22, 2026
National FoodsPakistan	MANGO (SUBTROPICAL AND TROPICAL FRUIT)Foods · 21SCI05	Poisonous or harmful substance	Oct 22, 2026
BNC GlobalSouth Korea	MISCELLANEOUS PATENT MEDICINES, ETC.Drugs · 66VDK99	708LIST A; 708NOREG A	Oct 22, 2026
Japan Bio Products Co.,LtdJapan	INJECTOR, PENDevices · 80NSC	Drug or device not listed with FDA; Device distributor not registered	Oct 22, 2026
THE SNUS BROTHERSSweden	NICOTINE POUCHTobacco · 98NCA11	Tobacco product without a marketing order; Tobacco product not reported to FDA	Oct 22, 2026
ERIS THERAPEUTICS LTDIndia	CALCITRIOL (ANTI-HYPERCALCEMIC)Drugs · 62ACJ04	Unapproved new drug	Oct 22, 2026

FDA's monthly Import Refusal Report data file for 2024 to date: one row per refused entry line, with the firm FDA names as manufacturer, its FEI, the product code and FDA's charges. A refusal is FDA's decision that a shipment appears to violate the FD&C Act; the firm can export or destroy it. Product type comes from the code's industry digits. FDA Import Refusal Report