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Import Refusal Records

503,850 FDA import refusal records

DateFirmCountryProductViolations
10/23/2025Edwards Lifesciences

Bajos De Haina

DOMINICAN TRANSDUCER, PRESSURE, CATHETER TIP
237NO PMA
10/23/2025IVC Nutrition Corporation

Taizhou

CHINAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
218LIST INGRE
260FALSE
+1 more
10/23/2025IVC Nutrition Corporation

Taizhou

CHINAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
218LIST INGRE
260FALSE
+1 more
10/23/2025IVC Nutrition Corporation

Taizhou

CHINAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
218LIST INGRE
260FALSE
+1 more
10/23/2025IVC Nutrition Corporation

Taizhou

CHINAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
218LIST INGRE
223FALSE
+2 more
10/23/2025Procter & Gamble, Inc.

Cabuyao

PHILIPPINEMOISTURIZING (SKIN CARE PREPARATIONS)
197COSM COLOR
10/23/2025Procter & Gamble, Inc.

Cabuyao

PHILIPPINEMOISTURIZING (SKIN CARE PREPARATIONS)
197COSM COLOR
10/23/2025ZHANGHAICHAO

Luoyang

CHINAFLOSS, DENTAL
118NOT LISTED
3280FRNMFGREG
+1 more
10/23/2025LINHAI CITY KANGBO GLASSES CO., LTD.

Taizhou

CHINASUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
3280FRNMFGREG
+1 more
10/23/2025REDDYS LAB PVT

Solan

INDIAKETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY)
118NOT LISTED
3280FRNMFGREG
10/23/2025SEAMAC FORMULATION LTD

Pradesh

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
118NOT LISTED
3280FRNMFGREG
10/23/2025Sun Pharma Laboratories Ld

East-Sikkim

INDIAFEBUXOSTAT (XANTHINE OXIDASE INHIBITOR)
118NOT LISTED
3280FRNMFGREG
10/23/2025OXFORD PHARMA

HARDIWAR

INDIAESTRADIOL (ESTROGEN)
118NOT LISTED
3280FRNMFGREG
10/23/2025DIVYAJIVAN LIFE SCIENCE PVT LTD

Gujarat

INDIAFOLIC ACID (VITAMIN)
118NOT LISTED
3280FRNMFGREG
10/23/2025UNISON PHARMACEUTICALS PVT LTD

SANAND

INDIALOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
118NOT LISTED
3280FRNMFGREG
10/23/2025SANOFI INDIA LTD

Ahmedabad

INDIAIBUPROFEN (ANTI-INFLAMMATORY)
118NOT LISTED
3280FRNMFGREG
10/23/2025UNISON PHARMACEUTICALS PVT LTD

SANAND

INDIAACETAMINOPHEN (ANALGESIC)
118NOT LISTED
3280FRNMFGREG
10/22/2025ALTRUAN GMBH

Massing

GERMANYOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
3280FRNMFGREG
+1 more
10/22/2025PROMOITALIA MEDICAL AESTHETICS

Milan

ITALYIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
508NO 510(K)
118NOT LISTED
+2 more
10/22/2025Q-Med AB

Uppsala

SWEDENIMPLANT, DERMAL, FOR AESTHETIC USE IN THE HANDS
118NOT LISTED
3280FRNMFGREG
+2 more
10/22/2025HALEON US HOLDINGS

Parsippany

UNITED STANICOTINE DELIVERY SYSTEM
118NOT LISTED
3280FRNMFGREG
10/22/2025Zenith Drinks Pvt.Ltd.

New Delhi

INDIAVITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
118NOT LISTED
3280FRNMFGREG
10/22/2025ALTRUAN GMBH

Massing

GERMANYOVER-THE-COUNTER COVID-19 ANTIGEN TEST
118NOT LISTED
3280FRNMFGREG
10/22/2025METHODOLOGY

Seoul

SOUTH KOREIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
+1 more
10/22/2025Hetero Labs Ltd

Sanath Nagar

INDIAMIRABEGRON (ADRENERGIC)
118NOT LISTED
10/22/2025PEGAVISION CORPORATION

Dashi

TAIWANLENS, CONTACT (OTHER MATERIAL) - DAILY
84RX DEVICE
10/22/2025PEGAVISION CORPORATION

Dashi

TAIWANLENS, CONTACT (OTHER MATERIAL) - DAILY
84RX DEVICE
10/22/2025PEGAVISION CORPORATION

Dashi

TAIWANLENS, CONTACT (OTHER MATERIAL) - DAILY
84RX DEVICE
10/22/2025PEGAVISION CORPORATION

Dashi

TAIWANLENS, CONTACT (OTHER MATERIAL) - DAILY
84RX DEVICE
10/22/2025Unilever Dept ER

Wirral

UNITED KINDEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/22/2025Unilever Dept ER

Wirral

UNITED KINDEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/22/2025Unilever Dept ER

Wirral

UNITED KINDEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/22/2025Unilever Dept ER

Wirral

UNITED KINDEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/22/2025Unilever Dept ER

Wirral

UNITED KINDEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/22/2025Unilever Dept ER

Wirral

UNITED KINDEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/22/2025Unilever Dept ER

Wirral

UNITED KINDEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/22/2025Unilever Dept ER

Wirral

UNITED KINDEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/22/2025Unilever Dept ER

Wirral

UNITED KINDEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/22/2025Unilever Dept ER

Wirral

UNITED KINDEODORANTS (UNDERARM)(NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
10/22/2025Pfizer Manufacturing Deutschland GmbH

Freiburg Im Breisgau

GERMANYAPIXABAN (ANTI-COAGULANT)
75UNAPPROVED
10/22/2025LABORATORIOS LAMFER ARA MED PHAR

Guatemala

MEXICOPIROXICAM (ANTI-INFLAMMATORY)
75UNAPPROVED
10/22/2025LABORATORY NEOETHICALS

Mixco

GUATEMALAIBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
10/22/2025LABORATORY NEOETHICALS

Mixco

GUATEMALADICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
10/22/2025Laboratorios Coaspharma

Bogota

COLOMBIAANTIBIOTIC N.E.C.
75UNAPPROVED
10/22/2025Laboratorios Coaspharma

Bogota

COLOMBIAVITAMIN E (TOCOPHEROL)
75UNAPPROVED
10/22/2025AstraZeneca Canada Inc.

Mississauga

CANADABUDESONIDE (ANTI-ASTHMATIC)
75UNAPPROVED
10/22/2025PRATI DONADUZZI LTDA

Toledo

BRAZILACYCLOVIR (ANTI-VIRAL)
75UNAPPROVED
10/22/2025Ems S.A.

Hortolandia

BRAZILFAMCICLOVIR (ANTI-VIRAL)
75UNAPPROVED
10/22/2025Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco)

Tlajomulco De Zuniga

MEXICOPOTASSIC SALINE (INJECTION) (REPLENISHER)
75UNAPPROVED
10/22/2025STERN PHARMA GMBH SA DE CV

Ocoyoacac

MEXICOIPRATROPIUM BROMIDE (BRONCHODILATOR)
75UNAPPROVED
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About This Page

This page displays 50 FDA import refusal records from 16 countries. Records on this page involve violations including 237 (NO PMA), 218 (LIST INGRE), 260 (FALSE), 482 (NUTRIT LBL), 223 (FALSE) and 7 more violation types. Each record links to detailed firm profiles with complete violation history and risk assessments.

Viewing page 188 of 10,077 • Showing records 9,351-9,400 of 503,850 total