Is Merck S A on an FDA import alert?

No listing for Merck S A appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the Guatemala page.

Has FDA refused shipments from Merck S A?

Yes. FDA refused 6 shipment lines from Merck S A between August 27, 2025 and September 17, 2026. The most recent, on September 17, 2026, was vitamin b12 (cyanocobalamin), charged as UNAPPROVED (unapproved new drug).

Why did FDA refuse Merck S A's shipments?

The most frequent charges are UNAPPROVED (unapproved new drug, 5 lines) and LACKS FIRM (manufacturer name and address missing, 1 line).

What is Merck S A's FEI number?

Merck S A's FDA Establishment Identifier (FEI) is 3013133263.

Merck S A

FDA import alert and refusal historyMixco, GuatemalaFEI 3013133263

Recorded by FDA as MERCK S A

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As of October 25, 2026, Merck S A is not on any FDA import alert in SupplierRadar's records; FDA refused 6 of its shipment lines between August 27, 2025 and September 17, 2026, most often for unapproved new drug (UNAPPROVED).

Data from FDA public records, last checked October 25, 2026. Request a correction

Current status

Import alerts: Not listed
Last import refusal: Sep 17, 2026Vitamin b12 (cyanocobalamin) · UNAPPROVED
Last warning letter: None found
Last inspection: None on record

Every FDA record for Merck S A

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

2026

Sep 17, 2026Import refusal
Refused, Vitamin b12 (cyanocobalamin)UNAPPROVEDEntry 1FX-3437312-7
Source
Aug 13, 2026Import refusal
Refused, Vitamin b1 (thiamine)LACKS FIRMEntry 1FX-2592026-5
Source
Aug 13, 2026Import refusal
Refused, Ashwagandha (herbal & botanicals, not teas)NOT LISTED UNAPPROVEDEntry 1FX-6202563-0
Source
Jul 1, 2026Import refusal
Refused, Vitamin b1 (thiamine)UNAPPROVEDEntry 1FX-4666446-1
Source
Jun 12, 2026Import refusal
Refused, Multiple vitamins (mvi-12 vitamin combo) (vitamin)UNAPPROVEDEntry 1FX-0135731-8
Source

2025

Aug 27, 2025Import refusal
Refused, Vitamin, mineral, proteins and unconventional dietary specialities for humans and animals, n.e.c.UNAPPROVEDEntry AEK-7377604-7
Source

Refusal charges, in plain English

UNAPPROVED5 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.
LACKS FIRM1 refused line
Manufacturer name and address missing
The packaged product's label appeared not to show the name and place of business of the manufacturer, packer, or distributor.
NOT LISTED1 refused line
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.

Questions about Merck S A

Is Merck S A on an FDA import alert?: No listing for Merck S A appears in the FDA import alerts SupplierRadar checked on October 25, 2026. Country-wide alerts may still apply to its products; see the Guatemala page.
Has FDA refused shipments from Merck S A?: Yes. FDA refused 6 shipment lines from Merck S A between August 27, 2025 and September 17, 2026. The most recent, on September 17, 2026, was vitamin b12 (cyanocobalamin), charged as UNAPPROVED (unapproved new drug).
Why did FDA refuse Merck S A's shipments?: The most frequent charges are UNAPPROVED (unapproved new drug, 5 lines) and LACKS FIRM (manufacturer name and address missing, 1 line).
What is Merck S A's FEI number?: Merck S A's FDA Establishment Identifier (FEI) is 3013133263.

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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.