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Merck, S.A. de C.V.

FDA import alert and refusal historyNaucalpan De Juarez, MexicoFEI 3004641553

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Example subjectMerck, S.A. de C.V added to Import Alert 16-129 (red list)

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As of October 26, 2026, Merck, S.A. de C.V. is not on any FDA import alert in SupplierRadar's records; FDA refused 22 of its shipment lines between January 4, 2017 and September 17, 2026, most often for unapproved new drug (UNAPPROVED).

Data from FDA public records, last checked . Request a correction

Current status

Import alerts
Not listed
Last import refusal
Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c. · DIETARYLBL
Last warning letter
None found
Last inspection
None on record

Every FDA record for Merck, S.A. de C.V.

22 records, newest first. Each line links to the FDA page it came from.

2026

  1. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.DIETARYLBLNO ENGLISHNUTRIT LBLEntry 1FX-0668404-8
    Source
  2. Import refusal
    Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry 1FX-8990523-6
    Source
  3. Import refusal
    Refused, Vitamin b6 (pyridoxine)NOT LISTEDUNAPPROVEDEntry AEK-0705246-6
    Source
  4. Import refusal
    Refused, 2 lines in one entry: Vitamin b1 (thiamine)NO ENGLISHUNAPPROVEDEntry AEK-0362280-9Show 2 lines
    Source
  5. Import refusal
    Refused, Multiple vitamins (mvi-12 vitamin combo) (vitamin)NO ENGLISHNUTRIT LBLEntry AEK-0074756-7
    Source

2025

  1. Import refusal
    Refused, Vitamin, n.e.c.UNAPPROVEDEntry 799-3578575-0
    Source
  2. Import refusal
    Refused, 5 lines in one entry: Vitamin b1 (thiamine); Hydroxocobalamin (vitamin) and 1 moreUNAPPROVEDEntry 799-5811641-1Show 5 lines
    Source

2023

  1. Import refusal
    Refused, Vitamin b1 (thiamine)UNAPPROVEDEntry 799-6606548-4
    Source

2022

  1. Import refusal
    Refused, Vitamin b2 (riboflavin)UNAPPROVEDEntry 799-0673231-8
    Source
  2. Import refusal
    Refused, 2 lines in one entry: Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-0711324-5Show 2 lines
    • Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-0711324-5Source
    • Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-0711324-5Source
    Source
  3. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-0646686-7
    Source
  4. Import refusal
    Refused, Vitamin b6 (pyridoxine)NOT LISTEDFRNMFGREGUNAPPROVEDEntry SCS-2293531-9
    Source

2020

  1. Import refusal
    Refused, Vitamin b1 (thiamine)UNAPPROVEDEntry 799-9651804-7
    Source

2019

  1. Import refusal
    Refused, Vitamin, n.e.c.UNAPPROVEDEntry 799-9792578-6
    Source

2017

  1. Import refusal
    Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry 799-9872142-2
    Source
Show 1 earlier record (2017)

2017

  1. Import refusal
    Refused, Vitamin, n.e.c.UNAPPROVEDEntry 799-8354808-7
    Source

Refusal charges, in plain English

  • UNAPPROVED20 refused lines

    Unapproved new drug

    The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.

  • NO ENGLISH4 refused lines

    Required label information not in English

    Information that must appear on the label appeared not to be given in English, or not to be repeated in every language used on the label.

  • NOT LISTED2 refused lines

    Product not listed with FDA

    The product appeared to be a drug or device that is not included in the listing FDA requires under section 510(j) of the FD&C Act.

  • NUTRIT LBL2 refused lines

    Nutrition information missing from label

    The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.

  • DIETARYLBL1 refused line

    Not identified as a dietary supplement

    The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).

  • FRNMFGREG1 refused line

    FRNMFGREG

Questions about Merck, S.A. de C.V.

Is Merck, S.A. de C.V. on an FDA import alert?
No listing for Merck, S.A. de C.V. appears in the FDA import alerts SupplierRadar checked on October 26, 2026. Country-wide alerts may still apply to its products; see the Mexico page.
Has FDA refused shipments from Merck, S.A. de C.V.?
Yes. FDA refused 22 shipment lines from Merck, S.A. de C.V. between January 4, 2017 and September 17, 2026. The most recent, on September 17, 2026, was vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c., charged as DIETARYLBL (not identified as a dietary supplement).
Why did FDA refuse Merck, S.A. de C.V.'s shipments?
The most frequent charges are UNAPPROVED (unapproved new drug, 20 lines) and NO ENGLISH (required label information not in english, 4 lines).
What is Merck, S.A. de C.V.'s FEI number?
Merck, S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3004641553.

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Example subjectMerck, S.A. de C.V added to Import Alert 16-129 (red list)

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SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.