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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
12/18/2025DR REDDY LABORATORIE API

Jinnaram

INDIAANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
12/18/2025SANOFI CONSUMER HEALTHCARE INDIA

Mumbai

INDIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
12/18/2025ABBOTT INDIA LTD

GOA

INDIALACTULOSE (CATHARTIC)
75UNAPPROVED
12/18/2025CILPA LTD

Mumbai

INDIAIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
12/18/2025CADILA HEALTHCARE LTD

Goa

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
12/18/2025GlaxoSmith Kline

Nashik

INDIAMUPIROCIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)
75UNAPPROVED
12/18/2025Ipg Life Science Ltd

Ankleshwar

INDIANAPROXEN (ANTI-INFLAMMATORY)
75UNAPPROVED
12/18/2025PURE AND CURE HEALTH CARE PVT LT

Ranipur Haridwar

INDIAMONTELUKAST SODIUM (ANTI-ASTHMATIC)
75UNAPPROVED
12/18/2025CIPLA LTD

Ahmedabad

INDIABACITRACIN ZINC (PEPTIDES)
75UNAPPROVED
12/18/2025CIPLA LTD

Ahmedabad

INDIACIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
12/18/2025ZYDUS HEALTHCARE LTD

East Sikkim

INDIAPANTOPRAZOLE SODIUM
75UNAPPROVED
12/18/2025Abbvie Corporation

Saint-Laurent

CANADACALCITONIN (ANTI-HYPERCALCEMIC)
75UNAPPROVED
12/18/2025NOVO NORDISK

Latina Scalo

ITALYTIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
12/18/2025PURE AND CURE HEALTHCARE

Delhi

INDIABETAMETHASONE (GLUCOCORTICOID)
75UNAPPROVED
12/18/2025PURE AND CURE HEALTHCARE

Delhi

INDIACIPROFLOXACIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
12/18/2025SUN PHARMA LABORATORIES LTD

Palasbari

INDIAAZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
12/18/2025EMCARE PHARMACEUTICALS

Bari Brahmana

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
12/18/2025EMCARE PHARMACEUTICALS

Bari Brahmana

INDIADICLOFENAC SODIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
12/18/2025Mankind Pharma Ltd.

New Delhi

INDIACEFPODOXIME PROXETIL (CEPHALOSPORINS)
75UNAPPROVED
12/18/2025TACTUS NUTRASCIENCES LLP

Ahmedabad

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
12/18/2025TORRENT PHARMACEUTICALS LTD

Gangtok Sikkim

INDIALOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
12/18/2025Niranta

Mumbai

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
12/18/2025AYUCARE PHARMACEUTICALS PVT

Ahmedabad

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
12/18/2025AUSHADHI BHAVAN AYURVED

Nashik

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
12/18/2025AUSHADHI BHAVAN AYURVED

Nashik

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
12/18/2025SHREE MAHANARAYAN

Ahmedabad

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
12/18/2025Vyas Pharmaceuticals

Indore

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
12/18/2025MEWAD AYURVEDIC WORKS

Baliya

INDIAHERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
12/18/2025ABBOTT INDIA

BADDI

INDIATHYROXINE I 125 (RADIOACTIVE AGENT)
75UNAPPROVED
12/18/2025Alkem Health Science

Sikkim

INDIAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
12/18/2025Alkem Health Science

Sikkim

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
12/18/2025MEDREICH LIMITED

Bengaluru

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
12/18/2025AstraZeneca Canada Inc.

Mississauga

CANADAPANTOPRAZOLE SODIUM
75UNAPPROVED
12/18/2025AstraZeneca Canada Inc.

Mississauga

CANADAROSUVASTATIN CALCIUM
75UNAPPROVED
12/18/2025BRITANNICA REMEDY'S RX PHARMACY

Winnipeg

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
12/18/2025HILL HERBS UTTRAKHAND

Uttarakhand

INDIAAMMONIA DETOXICANT, N.E.C.
75UNAPPROVED
12/18/2025DR LAL SINGH PHARMA

Delhi

INDIALEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
12/18/2025ADVEN PHARMA

Gurgaon

INDIAAMINOGLYCOSIDES, N.E.C.
75UNAPPROVED
12/18/2025ADVEN PHARMA

Gurgaon

INDIAHOMEOPATHIC N.E.C.
75UNAPPROVED
12/18/2025ADVEN PHARMA

Gurgaon

INDIACALCIUM ACETATE (ANTACID)
75UNAPPROVED
12/18/2025ADVEN PHARMA

Gurgaon

INDIATHYROID HORMONE N.E.C.
75UNAPPROVED
12/18/2025Abbvie Corporation

Saint-Laurent

CANADALINACLOTIDE (AGONIST)
75UNAPPROVED
12/18/2025Pfizer Canada

Kirkland

CANADAAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
12/18/2025Eli Lilly Canada Inc.

Scarborough

CANADAPROTAMINE ZINC INSULIN (SUSP) (ANTI-DIABETIC)
75UNAPPROVED
12/18/2025FAES FARMA PORTUGAL, S.A.

Amadora

PORTUGALPREDNIVAL (GLUCOCORTICOID)
75UNAPPROVED
12/18/2025NOVO NORDISK

Mississauga

CANADASEMAGLUTIDE (ANTI-DIABETIC)
75UNAPPROVED
12/18/2025GLAND PHARMA LIMITED

Hyderabad

INDIAPHARMACEUTIC NECESSITIES, N.E.C.
75UNAPPROVED
12/18/2025PRIME PEPTIDES

Maharashtr

INDIAIMMUNOLOGICAL AGENT, NEC
75UNAPPROVED
12/18/2025PEPTIDE SCIENCES

Himachal

INDIATIRZEPATIDE (ANTI-DIABETIC)
75UNAPPROVED
12/18/2025EMPOWER PHARMACY

Chandigarh

INDIACARDIOVASCULAR AGENT, NEC
75UNAPPROVED

About This Page

This page displays 50 FDA import refusal records from 4 countries. Records on this page involve violations including 75 (UNAPPROVED). Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 53 of 10,077 • Showing records 2,601-2,650 of 503,850 total