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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
9/29/2025KEDA DHARMESH MANUBHAI

Surat

INDIAMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
9/29/2025REHAN BEG

Badarpur

INDIATADALAFIL
118NOT LISTED
75UNAPPROVED
9/29/2025Macleods Pharmaceuticals Limited, Sarigam

District Valsad

INDIAOFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC)
118NOT LISTED
75UNAPPROVED
9/29/2025HEALING PHARMA INDIA

Mumbai

INDIATRETINOIN (REPLENISHER)
118NOT LISTED
75UNAPPROVED
9/29/2025Synthimed Labs Private Limited

Mohali

INDIABETAMETHASONE (GLUCOCORTICOID)
118NOT LISTED
75UNAPPROVED
9/29/2025VHC PHARMACEUTICALS

Jalandhar

INDIAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
75UNAPPROVED
9/29/2025MELTIC HEALTHCARE PVT. LTD.

Haryana

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
118NOT LISTED
75UNAPPROVED
9/29/2025MICRO LABS LIMITED

Hosur

INDIAAMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
118NOT LISTED
75UNAPPROVED
9/29/2025CADILA PHARMACEUTICAL LTD

Ahmedabad

INDIAROSUVASTATIN CALCIUM
118NOT LISTED
75UNAPPROVED
9/29/2025MR SURJIT SINGH

Adarsh

INDIATRETINOIN (KERATOLYTIC)
118NOT LISTED
75UNAPPROVED
9/29/2025MR SURJIT SINGH

Adarsh

INDIACOAL TAR (ANTI-ECZEMATIC)
118NOT LISTED
75UNAPPROVED
9/29/2025MR SURJIT SINGH

Adarsh

INDIAAZITHROMYCIN (MACAROLIDES)
118NOT LISTED
75UNAPPROVED
9/29/2025MR SURJIT SINGH

Adarsh

INDIAISOTRETINOIN (KERATOLYTIC)
118NOT LISTED
75UNAPPROVED
9/29/2025BC LTD C/O PASTURE

Singapore

SINGAPOREEMPAGLIFLOZIN (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
9/29/2025BC LTD C/O PASTURE

Singapore

SINGAPOREAPIXABAN (ANTI-COAGULANT)
118NOT LISTED
75UNAPPROVED
9/29/2025BC LTD C/O PASTURE

Singapore

SINGAPOREDAPAGLIFLOZIN (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
9/29/2025PASTURE PHARMA PTE LTD

Singapore

SINGAPOREAPIXABAN (ANTI-COAGULANT)
118NOT LISTED
75UNAPPROVED
9/29/2025Novo Nordisk Pharmaceutical

Sao Paulo

BRAZILSEMAGLUTIDE (ANTI-DIABETIC)
118NOT LISTED
75UNAPPROVED
9/29/2025ELI LILLY & COMPANIA DE MEXICO

Ciudad De Mexico

MEXICOFLUOXETINE (ANTI-DEPRESSANT)
118NOT LISTED
75UNAPPROVED
9/29/2025PRODUCTOS MAVER SA DE CV

Morelia

MEXICOLOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
75UNAPPROVED
9/29/2025PRODUCTOS FARMACEUTICOS COLLINS

Morelia

MEXICOPRECIPITATED CALCIUM CARBONATE (ANTACID)
118NOT LISTED
75UNAPPROVED
9/29/2025Dishman Netherlands BV

Weesp

NETHERLANDDYDROGESTERONE (PROGESTIN)
118NOT LISTED
75UNAPPROVED
9/29/2025Organon Pharma Mexico, S.A. de C.V.

Ciudad De Mexico

MEXICOTIBOLONE (ANABOLIC)
118NOT LISTED
75UNAPPROVED
9/29/2025Laboratorios Sanfer SA de CV

Ciudad De Mexico

MEXICOMISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
9/29/2025Procaps S.A.

Barranquilla

COLOMBIADICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
118NOT LISTED
75UNAPPROVED
9/29/2025CAPLIN POINT

Nadu

INDIAAMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
118NOT LISTED
75UNAPPROVED
9/29/2025Laboratorios Vijosa, S.A. de C.V.

Antiguo Cuscatlan

EL SALVADOVITAMIN B1 (THIAMINE)
118NOT LISTED
75UNAPPROVED
9/29/2025Laboratorios Vijosa, S.A. de C.V.

Antiguo Cuscatlan

EL SALVADOVITAMIN B1 (THIAMINE)
118NOT LISTED
75UNAPPROVED
9/29/2025Ferrer Internacional

Barcelona

SPAINANTI-INFLAMMATORY N.E.C.
118NOT LISTED
75UNAPPROVED
9/29/2025Tablets India Ltd

Chennai

INDIAMULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN)
118NOT LISTED
75UNAPPROVED
9/29/2025QUIBI SA

San Pedro Sula

HONDURASCALCIUM CHLORIDE, DEXTROSE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, SODIUM LACTATE, PERITONEAL DIALYSIS
118NOT LISTED
75UNAPPROVED
9/29/2025MENARINI GROUP

Florence

ITALYSILDENAFIL CITRATE (REGULATOR)
118NOT LISTED
75UNAPPROVED
9/29/2025NEOLABMA DE M XICO

Centro

MEXICOMINOXIDIL (ANTI-HYPERTENSIVE)
118NOT LISTED
75UNAPPROVED
9/29/2025FARMAPIEL

Monterrey

MEXICOISOTRETINOIN (KERATOLYTIC)
118NOT LISTED
75UNAPPROVED
9/29/2025LAB FARMACEUTICOS MK

Ciudad De Guate

GUATEMALAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
75UNAPPROVED
9/29/2025LAB FARMACEUTICOS MK

Ciudad De Guate

GUATEMALAIBUPROFEN (ANTI-INFLAMMATORY)
118NOT LISTED
75UNAPPROVED
9/29/2025APS FARMA

Guatemala

GUATEMALANITAZOXANIDE
118NOT LISTED
75UNAPPROVED
9/29/2025GLOBAL LABS

Mixco

GUATEMALAREPLENISHER N.E.C.
118NOT LISTED
75UNAPPROVED
9/29/2025Infasa

Mixco

GUATEMALAREPLENISHER N.E.C.
118NOT LISTED
75UNAPPROVED
9/29/2025GRUPO MENARINI

Guatemala

GUATEMALAFERROUS GLUCONATE (HEMATINIC)
118NOT LISTED
75UNAPPROVED
9/29/2025APS FARMA

Guatemala

GUATEMALAREPLENISHER N.E.C.
118NOT LISTED
75UNAPPROVED
9/29/2025LANKETIN

Guatemala City

GUATEMALAEXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
9/29/2025BC LTD C/O PASTURE

Singapore

SINGAPOREAFOXOLANER (ANTIPARASITIC)
118NOT LISTED
72NEW VET DR
9/29/2025Cosmecca Korea Co., Ltd.

Eumseong

SOUTH KOREMOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
9/29/2025Pfizer Manufacturing Belgium NV

Puurs-Sint-Amands

BELGIUMETANERCEPT
75UNAPPROVED
9/29/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
+1 more
9/29/2025Sabritas S. de R.L. de C.V. Planta Saltillo

Saltillo

MEXICOWHEAT GRAIN SNACK (WHOLE, CRACKED, SPLIT), FRIED/OIL COOKED
11UNSAFE COL
274COLOR LBLG
+1 more
9/29/2025MONDELEZ MEXICO S DE RL D CV

Puebla

MEXICOCHEWING GUM (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
9/29/2025MONDELEZ MEXICO S DE RL D CV

Puebla

MEXICOCHEWING GUM (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
9/29/2025BAHAUDDIN AL-BASTANJI AND PARTNERS COMPANY

Amman

JORDANSOFT CANDY WITH NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
9SALMONELLA

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 118 (NOT LISTED), 75 (UNAPPROVED), 72 (NEW VET DR), 11 (UNSAFE COL), 274 (COLOR LBLG) and 2 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 238 of 10,077 • Showing records 11,851-11,900 of 503,850 total