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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/21/2026Sanofi Medley Farmaceutica Ltda.

Suzano

BRAZILLEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
1/21/2026ACHE LABORATORIOS FARMACEUTICOS

Sao Paulo

BRAZILDESVENLAFAXINE SUCCINATE
75UNAPPROVED
1/21/2026Aspen Farmaceutica S/A

Sao Paulo

BRAZILTRAZODONE HCL (ANTI-DEPRESSANT)
75UNAPPROVED
1/21/2026NOVAMED FABRICACAO DE PRODUCTOS

Manaus

BRAZILQUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
1/21/2026ODONTOLGIA CAMPAGNONE

Valinhos

BRAZILORPHENADRINE CITRATE (RELAXANT)
75UNAPPROVED
1/21/2026ODONTOLGIA CAMPAGNONE

Valinhos

BRAZILSILDENAFIL CITRATE (REGULATOR)
75UNAPPROVED
1/21/2026SUNRISE REMEDIES PVT LTD

Gujarat

INDIAPENTAZOCINE (ANALGESIC)
75UNAPPROVED
1/21/2026SUNRISE REMEDIES PVT LTD

Gujarat

INDIAFENBENDAZOLE (ANTHELMINTIC)
75UNAPPROVED
1/21/2026AstraZeneca Pharmaceuticals LP

Wilmington

UNITED STADAPAGLIFLOZIN (ANTI-DIABETIC)
75UNAPPROVED
1/21/2026MERCK SERONO GMBH

Weiterstadt

GERMANYBISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
1/21/2026ASOFARMA

San Jose

COSTA RICAOLMESARTAN MEDOXOMIL
75UNAPPROVED
1/21/2026NIPRO PHARMA LABORATORY

Doral

UNITED STAMECOBALAMIN (VITAMIN)
75UNAPPROVED
1/21/2026RITS LIFESCIENCES PRIVATE LIMITE

Ol[Ad Gu

INDIADIETARY CONVENTIONAL FOODS, N.E.C.
75UNAPPROVED
1/21/2026THE CALLIGRAPHY BOX

Dundee

UNITED KINGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
1/21/2026WORLD STAR TECHNOLOGIES

Markham

CANADAGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
1/21/2026Laboratorios Jaloma S.A. de C.V.

Guadalajara

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
75UNAPPROVED
1/21/2026Laboratorios Jaloma S.A. de C.V.

Guadalajara

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
75UNAPPROVED
1/21/2026Pepsico Inc

Purchase

UNITED STABEVERAGE BASE, CITRUS, LIQUID
11UNSAFE COL
1/21/2026PURE PROTEIN

Westminster

UNITED STACAKE WITHOUT CUSTARD OR CREAM FILLING
11UNSAFE COL
1/21/2026McCormick & Company - Corporate Headquarters

Hunt Valley

UNITED STASOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
1/21/2026LAJTHIZA INVEST SHA

Tirana

ALBANIAMIXED DRINKS (NONALCOHOLIC BEVERAGES)
11UNSAFE COL
1/21/2026Mars, Incorporated

Mc Lean

UNITED STACANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
1/21/2026Maritime Fisheries

Karachi

PAKISTANFISH, N.E.C.
9SALMONELLA
1/21/2026Maritime Fisheries

Karachi

PAKISTANFISH, N.E.C.
9SALMONELLA
1/21/2026Maritime Fisheries

Karachi

PAKISTANFISH, N.E.C.
9SALMONELLA
1/21/2026Maritime Fisheries

Karachi

PAKISTANFISH, N.E.C.
9SALMONELLA
1/21/2026Haldiram Foods International Pvt. Ltd

Nagpur

INDIACHILI SEASONING ( CHILI POWDER AND PAPRIKA) LIQUID WITHOUT SALT
9SALMONELLA
1/21/2026Haldiram Foods International Pvt. Ltd

Nagpur

INDIACURRY POWDER, WITHOUT SALT
9SALMONELLA
1/21/2026Haldiram Foods International Pvt. Ltd

Nagpur

INDIAWHOLE SPICE, N.E.C.
9SALMONELLA
1/21/2026Haldiram Foods International Pvt. Ltd

Nagpur

INDIASPICES, FLAVORS AND SALT NOT MENTIONED ELSEWHERE, N.E.C.
9SALMONELLA
1/21/2026Haldiram Foods International Pvt. Ltd

Nagpur

INDIACHILI SEASONING ( CHILI POWDER AND PAPRIKA) LIQUID WITHOUT SALT
9SALMONELLA
1/20/2026societatea comerciala TAINET, SRL

Comrat

MOLDOVASYRUPS AND MOLASSES, N.E.C.
3887ADDDRUGBIO
1/20/2026Shree Bhagwati Flour & Foods PVT. LTD

Changodar

INDIAGRAM FLOUR
3886FSVP VIO
1/20/2026Shree Bhagwati Flour & Foods PVT. LTD

Changodar

INDIAGRAM FLOUR
3886FSVP VIO
1/20/2026Shree Bhagwati Flour & Foods PVT. LTD

Changodar

INDIAGRAM FLOUR
3886FSVP VIO
1/20/2026Swedish Match Ab

Stockholm

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
1/20/2026ANHUI DONG BAO FOOD CO.,LTD.

Hefei City

CHINALEAF & STEM VEGETABLES, N.E.C.
3846807REFUSAL
1/20/2026LIW INNOVATION AB

Hokerum

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
1/20/2026PT. Tamron Akuatik Produk Industri

Serang

INDONESIASHRIMP & PRAWNS, BREADED
3220NITROFURAN
1/20/2026societatea comerciala TAINET, SRL

Comrat

MOLDOVAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
1/20/2026societatea comerciala TAINET, SRL

Comrat

MOLDOVAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
1/20/2026societatea comerciala TAINET, SRL

Comrat

MOLDOVAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
1/20/2026Gui Nan Hong Company Limited

Sheung Wan

HONG KONGWOLFBERRY (CHINESE OR SOUTHEAST ASIAN BERRY OF THE CHINESE MATRIMONY VINE, W/SLIGHT LICORICE FLAVOR)
482NUTRIT LBL
1/20/2026Gui Nan Hong Company Limited

Sheung Wan

HONG KONGHERBALS & BOTANICALS (NOT TEAS), N.E.C.
482NUTRIT LBL
1/20/2026NANJING CASELA TECHNOLOGIES CORP

Nanjing

CHINAFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
1/20/2026NANJING CASELA TECHNOLOGIES CORP

Nanjing

CHINAFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
1/20/2026NANJING CASELA TECHNOLOGIES CORP

Nanjing

CHINAFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
1/20/2026Grupo Gamesa, S.A. De C.V.

San Nicolas De Los Garza

MEXICOPLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
324NO ENGLISH
1/20/2026VALLON FARMDIRECT PVT LTD

Jodhpur

INDIASPICES, GROUND, CRACKED, ETC., N.E.C.
308MFR INSAN
1/20/2026CHENGDU FINC BIO-TECH CO., LTD.

Chengdu

CHINATSO GU (DRIED CHINESE GRASS MUSHROOMS, HAVE STRONGER FRAGRANCE THAN CHINESE DRIED MUSHROOMS)
295LISTERIA
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About This Page

This page displays 50 FDA import refusal records from 16 countries. Records on this page involve violations including 75 (UNAPPROVED), 47 (NON STD), 27 (DRUG GMPS), 11 (UNSAFE COL), 9 (SALMONELLA) and 11 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 6 of 10,077 • Showing records 251-300 of 503,850 total