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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/20/2026E-FILLERS SA

Athens

GREECEOTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
237NO PMA
+2 more
1/20/2026E-FILLERS SA

Athens

GREECEOTHER SKIN CARE PREPARATIONS, N.E.C.
118NOT LISTED
237NO PMA
+2 more
1/20/2026E-FILLERS SA

Athens

GREECEEYELASH CLEANSERS (EYE MAKEUP PREPARATIONS)
118NOT LISTED
237NO PMA
+2 more
1/20/2026Allergan

Parsippany

UNITED STAIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+2 more
1/20/2026MOMEN NAGED ELGLAZOULY

Edmonton

CANADACELECOXIB (ANALGESIC)
118NOT LISTED
1/20/2026The Hygenic Company LLC.

Akron

UNITED STAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
1/20/2026MOMEN NAGED ELGLAZOULY

Edmonton

CANADAPANTOPRAZOLE SODIUM
118NOT LISTED
1/20/2026Kimberly-Clark Inc

Huntsville

CANADAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
1/20/2026SHANGHAI INT MEDICAL INSTRUMENT

Shanghai

CHINANON-STAINLESS STEEL NEEDLE
118NOT LISTED
1/20/2026Pharmosa Biopharm Inc.

Taipei

TAIWANVASODILATOR N.E.C.
75UNAPPROVED
1/20/2026Pharmosa Biopharm Inc.

Taipei

TAIWANVASODILATOR N.E.C.
75UNAPPROVED
1/20/2026EMPWR CANADA

Pointe-Claire

CANADAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
75UNAPPROVED
1/20/2026ABBOTT INDIA LTD

Sidel

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/20/2026SUN PHARMA LABORATORIES LTD

Palasbari

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/20/2026GOLDEN CROSS PHARMA LTD

Rorathang

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
1/20/2026LABORATORIES ROWA PHARMACEUTICAL

Bergisch

GERMANYANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
1/20/2026Dr. Reddy's Laboratories

Hyderabad

INDIAACYCLOVIR; HYDROCORTISONE (ANTI-VIRAL)
75UNAPPROVED
1/20/2026LABORATORIES CALOX

San Jose

COSTA RICACIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
1/20/2026Unipharm

Guatemala

GUATEMALANITAZOXANIDE
75UNAPPROVED
1/20/2026Laboratorios Sante Sa

Colombia

COLOMBIAAZTREONAM (BACTAM (B-LACTAM ANTIBIOTIC))
75UNAPPROVED
1/20/2026Dr. Reddy's Laboratories

Hyderabad

INDIAACYCLOVIR (ANTI-VIRAL)
75UNAPPROVED
1/20/2026LABORATORIOS CEGUEL SA

Managua

NICARAGUADIPHENHYDRAMINE HCL (ANTI-HISTAMINIC)
75UNAPPROVED
1/20/2026SIVASAKTRI PHARMACEUTICALS PVT.

Coimbatore

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/20/2026SIVASAKTRI PHARMACEUTICALS PVT.

Coimbatore

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/20/2026SIVASAKTRI PHARMACEUTICALS PVT.

Coimbatore

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/20/2026SIVASAKTRI PHARMACEUTICALS PVT.

Coimbatore

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/20/2026SIVASAKTRI PHARMACEUTICALS PVT.

Coimbatore

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/20/2026SIVASAKTRI PHARMACEUTICALS PVT.

Coimbatore

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/20/2026FARMAMEDICA SA

Guatemala

GUATEMALAPENICILLIN NATURAL, N.E.C.
75UNAPPROVED
1/20/2026FARMAMEDICA SA

Guatemala

GUATEMALALANSOPRAZOLE (ANTI-SECRETORY)
75UNAPPROVED
1/20/2026FARMAMEDICA SA

Guatemala

GUATEMALABETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
1/20/2026FARMAMEDICA SA

Guatemala

GUATEMALAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
1/20/2026FARMAMEDICA SA

Guatemala

GUATEMALAGLYCINE (PROTEIN)
75UNAPPROVED
1/20/2026FARMAMEDICA SA

Guatemala

GUATEMALAVITAMIN B6 (PYRIDOXINE)
75UNAPPROVED
1/20/2026FARMAMEDICA SA

Guatemala

GUATEMALAPOTASSIC SALINE (INJECTION) (REPLENISHER)
75UNAPPROVED
1/20/2026UNIQUE PHARM NIGERIA LTD

Lagos

NIGERIAMETHYLDOPA (ANTI-HYPERTENSIVE)
75UNAPPROVED
1/20/2026HEALTHCARE PHARMA

Surrey

UNITED KINHYDROXYUREA (ANTI-NEOPLASTIC)
75UNAPPROVED
1/20/2026Bayer AG

Leverkusen

GERMANYRIVAROXABAN
75UNAPPROVED
1/20/2026BEST S A

Benito Juarez

MEXICODOXYCYCLINE (TETRACYCLINES)
75UNAPPROVED
1/20/2026BEST S A

Benito Juarez

MEXICOLIOTHYRONINE SODIUM (THYROID HORMONE)
75UNAPPROVED
1/20/2026BEST S A

Benito Juarez

MEXICOACYCLOVIR (ANTI-VIRAL)
75UNAPPROVED
1/20/2026BEST S A

Benito Juarez

MEXICOACYCLOVIR (ANTI-VIRAL)
75UNAPPROVED
1/20/2026AURAX LABORATORY

Mexico City

MEXICOVALACYCLOVIR HCL (ANTI-VIRAL)
75UNAPPROVED
1/20/2026LABORATORIOS GROSSMAN S.A

Coyoacan

MEXICOLIOTHYRONINE SODIUM (THYROID HORMONE)
75UNAPPROVED
1/20/2026Hetero Labs Limited - Unit III

Hyderabad

INDIALAMIVUDINE (ANTI-VIRAL)
75UNAPPROVED
1/20/2026Hetero Labs Limited - Unit III

Hyderabad

INDIALOPINAVIR; RITONAVIR (ANTI-VIRAL)
75UNAPPROVED
1/20/2026Geunsan Dukwon Co Ltd

Chungcheongnam-Do

SOUTH KOREGINSENG (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
1/20/2026Geumsan Black Ginseng Co. Ltd.

Geumsan

SOUTH KOREGINSENG (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
1/20/2026Bubs Godis

Jonkoping

SWEDENCANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
3865COLORLABEL
+1 more
1/20/2026Bubs Godis

Jonkoping

SWEDENCANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
3865COLORLABEL
+1 more
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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 118 (NOT LISTED), 237 (NO PMA), 3280 (FRNMFGREG), 341 (REGISTERED), 75 (UNAPPROVED) and 3 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 8 of 10,077 • Showing records 351-400 of 503,850 total