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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
12/19/2025Intas Pharmaceuticals Limited

Gangtok

INDIADESVENLAFAXINE SUCCINATE
75UNAPPROVED
12/19/2025SUN PHARMA LABORATORIES LIMITED

Gangtok

INDIAOXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
12/19/2025AstraZeneca AB

Sodertalje

SWEDENMETOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
12/19/2025BASHPHARMACIA

Ufa

RUSSIACHLORPROTHIXENE (TRANQUILIZER)
75UNAPPROVED
12/19/2025BASHPHARMACIA

Ufa

RUSSIATRAZODONE HCL (ANTI-DEPRESSANT)
75UNAPPROVED
12/19/2025BASHPHARMACIA

Ufa

RUSSIALEVOFLOXACIN (ANTI-BACTERIAL, PART III)
75UNAPPROVED
12/19/2025BASHPHARMACIA

Ufa

RUSSIAFLUVOXAMINE MALEATE (ANTI-DEPRESSANT)
75UNAPPROVED
12/19/2025BASHPHARMACIA

Ufa

RUSSIAHYDROXYZINE HCL (TRANQUILIZER)
75UNAPPROVED
12/19/2025Sai Life Sciences Limited

Hyderabad

INDIAANTIBIOTIC N.E.C.
75UNAPPROVED
12/19/2025Abbott Biologicals BV

Olst

NETHERLANDESTRADIOL (ESTROGEN)
75UNAPPROVED
12/19/2025MSN Laboratories Private Limited

Hyderabad

INDIAALLOPURINOL SODIUM (ANTI-INFLAMMATORY)
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
12/18/2025PEP SCIENCES

Himachal

INDIAENZYME, NEC
75UNAPPROVED
12/18/2025Jugos Del Valle S A. De C.V.

Tepotzotlan

MEXICOMIXED FRUIT, JUICES OR CONCENTRATES N.E.C.,
11UNSAFE COL
274COLOR LBLG
12/18/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/18/2025Comercializadora Pepsico Mexico,

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/18/2025SABRITAS, S.de R.L. de C.V.

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/18/2025SABRITAS, S.de R.L. de C.V.

Ciudad De Mexico

MEXICOCORN CHIPS, FRIED
11UNSAFE COL
274COLOR LBLG
12/18/2025Mircata Sweets Industry LLC

Ajman

UNITED ARACHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)
11UNSAFE COL
260FALSE
12/18/2025Mircata Sweets Industry LLC

Ajman

UNITED ARACHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)
11UNSAFE COL
260FALSE
12/18/2025Mircata Sweets Industry LLC

Ajman

UNITED ARACHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT
11UNSAFE COL
260FALSE
12/18/2025Mircata Sweets Industry LLC

Ajman

UNITED ARACHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT
11UNSAFE COL
260FALSE
12/18/2025Mircata Sweets Industry LLC

Ajman

UNITED ARACHOCOLATE CANDY BAR, WITH FRUIT AND FRUIT PRODUCTS
11UNSAFE COL
260FALSE
12/18/2025Mircata Sweets Industry LLC

Ajman

UNITED ARACHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)
11UNSAFE COL
260FALSE
12/18/2025cadbury nigeria plc

lagos

NIGERIACANDY WITHOUT CHOCOLATE N.E.C.
11UNSAFE COL
12/18/2025cadbury nigeria plc

lagos

NIGERIACANDY WITHOUT CHOCOLATE N.E.C.
11UNSAFE COL
12/18/2025Tit-Rahal Nigeria Company

Lagos

NIGERIACUSTARD MIX
11UNSAFE COL
12/18/2025INVERSIONES AGRICOLAS CENTURA SA

Ensenada

MEXICOCUCUMBERS (FRUIT USED AS VEGETABLE)
9SALMONELLA
12/18/2025NGP TOBACCO APS

Norager

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
12/18/2025CAREMED SUPPLY, INC.

Yilan County Iian

TAIWANSLEEVE, LIMB, COMPRESSIBLE
39043904
39053905
12/18/2025NGP TOBACCO APS

Norager

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
12/18/2025NGP TOBACCO APS

Norager

DENMARKNICOTINE POUCH
3854TPLKUSSLLB
12/18/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3854TPLKUSSLLB
12/18/2025CBI SRO

Teplice

CZECH REPUNICOTINE POUCH
3854TPLKUSSLLB
12/18/2025NICOTOBACCO

Sokolow

POLANDNICOTINE POUCH
3842TP NO PMTA
3851TPLACKFIRM
12/18/2025TRIDOTS UK

London

UNITED KINNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+2 more
12/18/2025TRIDOTS UK

London

UNITED KINNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+2 more
12/18/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+3 more
12/18/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+2 more
12/18/2025Swedish Match Ab

Stockholm

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+2 more
12/18/2025TIN JAR AB

Laxa

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+4 more
12/18/2025KURBITS SNUS AB

Spanga

SWEDENNICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
+4 more
12/18/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
12/18/2025PHILIP MORRIS AB

Stockholm

SWEDENNICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE

About This Page

This page displays 50 FDA import refusal records from 14 countries. Records on this page involve violations including 75 (UNAPPROVED), 11 (UNSAFE COL), 274 (COLOR LBLG), 260 (FALSE), 9 (SALMONELLA) and 8 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 51 of 10,077 • Showing records 2,501-2,550 of 503,850 total