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Import Refusal Records

501,854 FDA import refusal records

DateFirmCountryProductViolations
12/9/2025Bayer Sa

Gutatemala

GUATEMALAACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
12/9/2025CAPLIN POINT

Bodega

GUATEMALAAMIDEPHRINE MESYLATE (ADRENERGIC)
75UNAPPROVED
12/9/2025Infasa

Mixco

GUATEMALATRANQUILIZER N.E.C.
75UNAPPROVED
12/9/2025NESH PHARMA

Guatemala

GUATEMALAREGULATOR N.E.C.
75UNAPPROVED
12/9/2025CAPLIN POINT

Bodega

GUATEMALADICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
12/9/2025PIERSAN CENTROAMERICANO

Guatemala City

GUATEMALAVITAMIN B1 (THIAMINE)
75UNAPPROVED
12/9/2025MERCK S A

Mixco

GUATEMALAREGULATOR N.E.C.
75UNAPPROVED
12/9/2025LABORATORIO CALIQU MICA

Guatemala

GUATEMALAREGULATOR N.E.C.
75UNAPPROVED
12/9/2025LABORATORIOS PIERSAN

Guatemala

GUATEMALANAPHAZOLINE HCL (ADRENERGIC)
75UNAPPROVED
12/9/2025LABORATORIOS ANCALMO

Mariscal

GUATEMALAREPLENISHER N.E.C.
75UNAPPROVED
12/9/2025RPG LIFE SCIENCES LTD

Mumbai

INDIANAPROXEN (ANTI-INFLAMMATORY)
75UNAPPROVED
12/8/2025Centurion Laboratories

Gorwa

INDIASILDENAFIL CITRATE (REGULATOR)
75UNAPPROVED
12/8/2025ELI LILLY CANADA INC

Toronto

CANADAINSULIN GLARGINE
75UNAPPROVED
12/8/2025Planet Ayurveda Private Limited

Sas Nagar (Mohali)

INDIAASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS)
27DRUG GMPS
3560SUPPL GMP
+1 more
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
+1 more
12/8/2025Zenith Drinks Pvt.Ltd.

New Delhi

INDIAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
11UNSAFE COL
274COLOR LBLG
+1 more
12/8/2025Zenith Drinks Pvt.Ltd.

New Delhi

INDIAFOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS
11UNSAFE COL
274COLOR LBLG
+1 more
12/8/2025Inversiones Asaf S de RL de CV

El Negrito

HONDURASFLAVORED OR PARTY CRACKERS
11UNSAFE COL
274COLOR LBLG
12/8/2025Inversiones Asaf S de RL de CV

El Negrito

HONDURASVANILLA PLAIN COOKIE,BISCUIT AND WAFER
11UNSAFE COL
274COLOR LBLG
12/8/2025Indaco S.p.A.

Caivano

ITALYMIXED/ASSORTED HARD CANDY WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
218LIST INGRE
+1 more
12/8/2025Kraft Heinz Food Company

Holland

UNITED STANONALCOHOLIC BEVERAGES, N.E.C.
11UNSAFE COL
12/8/2025Lubia AMerica Perez Santos

Guayaquil

ECUADORMIXED SPICE AND SEASONINGS, GROUND, CRACKED, WITHOUT SALT, N.E.C.
11UNSAFE COL
12/8/2025YOU HONG FOODS CO.,LTD.

Tainan City

TAIWANSYRUPS AND MOLASSES, N.E.C.
11UNSAFE COL
12/8/2025CONCORD CONFECTIONS LTD

Concord

CANADACHEWING GUM, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
12/8/2025Sociedad Cooperativa de Consumo Lic. Alfredo V. Bonfil

San Luis Rio Colorado

MEXICOWHEAT FLOUR, ENRICHED (ALL PURPOSE)
9SALMONELLA
12/8/2025Sociedad Cooperativa de Consumo Lic. Alfredo V. Bonfil

San Luis Rio Colorado

MEXICOWHEAT FLOUR, ENRICHED (ALL PURPOSE)
9SALMONELLA
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025DULCES RENI SA DE CV

Guadalajara

MEXICOCANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH COCONUT (WITHOUT CHOCOLATE)
3886FSVP VIO
12/8/2025Swedish Match North Europe

Stockholm

SWEDENNICOTINE POUCH
3854TPLKUSSLLB

About This Page

This page displays 50 FDA import refusal records from 10 countries. Records on this page involve violations including 75 (UNAPPROVED), 27 (DRUG GMPS), 3560 (SUPPL GMP), 11 (UNSAFE COL), 274 (COLOR LBLG) and 5 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 31 of 10,038 • Showing records 1,501-1,550 of 501,854 total