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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
1/2/2026Letap Pharmaceuticals Ltd.

Accra

GHANATETRACYCLINE HYDROCHLORIDE (TETRACYCLINES)
118NOT LISTED
3280FRNMFGREG
1/2/2026NOVARTIS SAGLIK GIDA TARIM URUNLERI

Istanbul

TURKEYANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C.
118NOT LISTED
3280FRNMFGREG
1/2/2026Capital O2 Natural Health Company Ltd

South Odorkor

GHANAALOE (HERBAL AND BOTANICAL TEAS II, (CONTINUED))
118NOT LISTED
3280FRNMFGREG
1/2/2026SANG HEE KIM

Sejong

SOUTH KOREPRODUCTS, CONTACT LENS CARE, RIGID GAS PERMEABLE
118NOT LISTED
237NO PMA
+2 more
1/2/2026SANG HEE KIM

Sejong

SOUTH KORELENS, CONTACT (RIGID GAS PERMEABLE) - EXTENDED WEAR
118NOT LISTED
237NO PMA
+2 more
1/2/2026HASAKI BEAUTY & CLINIC JSC

Hanoi City

VIETNAMOTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
118NOT LISTED
237NO PMA
+1 more
1/2/2026Franco-Indian Laboratories

Mumbai

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
1/2/2026Sun Pharma Laboratories Ld

East-Sikkim

INDIAROSUVASTATIN CALCIUM
75UNAPPROVED
1/2/2026RAVENBHEI BIOTECH

Jammu

INDIAESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
75UNAPPROVED
1/2/2026MANKIND INDIA LTD

Delhi

INDIAAMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
1/2/2026Exemed Pharmaceuticals

Vapi

INDIASERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
1/2/2026Intas Pharmaceuticals Limited

Gangtok

INDIALAMOTRIGINE (ANTI-CONVULSANT)
75UNAPPROVED
1/2/2026Besins Manufacturing Belgium

Drogenbos

BELGIUMPROGESTERONE (PROGESTIN)
75UNAPPROVED
1/2/2026Besins Manufacturing Belgium

Drogenbos

BELGIUMESTRADIOL (ESTROGEN)
75UNAPPROVED
1/2/2026VINCENTE SCAVONE & CIA SAE

San Lorenzo

PARAGUAYZOLPIDEM TARTRATE (SEDATIVE)
75UNAPPROVED
1/2/2026SAVAL LAB

Santiago

CHILEBUPROPION HCL (ANTI-DEPRESSANT)
75UNAPPROVED
1/2/2026COLLINS S.A.

GUADALAJARA

MEXICOCEFTRIAXONE SODIUM (CEPHALOSPORINS)
75UNAPPROVED
1/2/2026COLLINS S.A.

GUADALAJARA

MEXICODEXAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
1/2/2026Dr. Reddy's Laboratories

Hyderabad

INDIAROSUVASTATIN CALCIUM
75UNAPPROVED
1/2/2026Dr. Reddy's Laboratories

Hyderabad

INDIAGLIMEPIRIDE (ANTI-DIABETIC)
75UNAPPROVED
1/2/2026Sun Pharmaceutical Industries

Mumbai

INDIAANTI-DIABETIC N.E.C.
75UNAPPROVED
1/2/2026Sun Pharmaceutical Industries

Mumbai

INDIAOLMESARTAN MEDOXOMIL
75UNAPPROVED
1/2/2026USV Private Limited

Vadodara

INDIAMETFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
1/2/2026KURUMBALA HERBAL AND RESEARCH

Tamilnadu

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/2/2026KURUMBALA HERBAL AND RESEARCH

Tamilnadu

INDIALEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
1/2/2026KURUMBALA HERBAL AND RESEARCH

Tamilnadu

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/2/2026KURUMBALA HERBAL AND RESEARCH

Tamilnadu

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/2/2026KURUMBALA HERBAL AND RESEARCH

Tamilnadu

INDIAASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
1/2/2026KURUMBALA HERBAL AND RESEARCH

Tamilnadu

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/2/2026KURUMBALA HERBAL AND RESEARCH

Tamilnadu

INDIAMETFORMIN (ANTI-DIABETIC)
75UNAPPROVED
1/2/2026Cipla Limited

Mumbai

INDIATORSEMIDE (DIURETIC)
75UNAPPROVED
1/2/2026Sun Pharmaceutical Industries Ltd

Mumbai

INDIAESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
75UNAPPROVED
1/2/2026ERIS LIFE SCIENCE LTD

Ahmedabad

INDIACALCIUM (MINERAL)
75UNAPPROVED
1/2/2026BOEHRINGER INGELHEIM INDIA PVT

Mumbai

INDIALINAGLIPTIN (ANTI-DIABETIC)
75UNAPPROVED
1/2/2026INTAS PHARMACEUTIAL

Thaltej

INDIACARVEDILOL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
1/2/2026LABORATORIOS LA SANTE

Bogota

COLOMBIATADALAFIL
75UNAPPROVED
1/2/2026ANTON GLOBAL PHARMACEUTCALS PVT

Mumbai

INDIAIVERMECTIN AND COMBINATIONS (ANTIPARASITIC)
75UNAPPROVED
1/2/2026DUKSAN PURE CHEMICALS CO., LTD.

Ansan

SOUTH KOREANTI-DEPRESSANT N.E.C.
75UNAPPROVED
1/2/2026MARCAN PHARMACEUTICALS INC

Nepean

CANADADOMPERIDONE
75UNAPPROVED
1/2/2026NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/2/2026LABORATORIOS BONIN S.A

Nueva

GUATEMALAPRAZOSIN HCL (ANTI-HYPERTENSIVE)
75UNAPPROVED
1/2/2026NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
1/2/2026SHREE PHARMA

Nagpur

INDIATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
1/2/2026GLAXOSMITHKLINE

Mississauga

CANADAFLUTICASONE PROPIONATE (BRONCHODILATOR)
75UNAPPROVED
1/2/2026GLAXOSMITHKLINE

Mississauga

CANADAIPRATROPIUM BROMIDE (BRONCHODILATOR)
75UNAPPROVED
1/2/2026ASIA HERBS

Punjab

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
1/2/2026AJANTA PHARMA LTD

Mumbai

INDIANETARSUDIL DIMESYLATE (ENZYME INHIBITOR)
75UNAPPROVED
1/2/2026Emami Limited

Pantnagar

INDIAMENTHOL (ANTI-PRURITIC)
75UNAPPROVED
1/2/2026Laborate Pharmaceuticals India Ltd.

Paonta Sahib

INDIAGENTAMICIN (AMINOGLYCOSIDES)
75UNAPPROVED
1/2/2026METOCRAFT

Baddi Solan

INDIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
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About This Page

This page displays 50 FDA import refusal records from 12 countries. Records on this page involve violations including 118 (NOT LISTED), 3280 (FRNMFGREG), 237 (NO PMA), 508 (NO 510(K)), 75 (UNAPPROVED). Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 39 of 10,077 • Showing records 1,901-1,950 of 503,850 total