What is Import Alert 16-121?

Import Alert 16-121, “Detention without physical examination of cooked seafood products due to E. coli”, is an FDA import alert. FDA may detain cooked seafood products from the firms on its red list without physical examination; FDA last published the alert on June 2, 2025.

Which firms are on Import Alert 16-121?

As of October 26, 2026, 3 firms are listed on Import Alert 16-121 in 3 countries; the most listings are in Hong Kong (1), Mexico (1) and Vietnam (1). The full table, grouped by country, is below on this page and every firm links to its record.

How do firms get off Import Alert 16-121?

A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 16-121; our guide explains the steps and the evidence FDA usually asks for.

What charge does FDA use under Import Alert 16-121?

The charge section of Import Alert 16-121 names FILTHY (filthy, putrid or decomposed substance), MFR INSAN (insanitary manufacturing, processing or packing) and INSANITARY (prepared, packed or held under insanitary conditions). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.

Import Alert 16-121: Detention without physical examination of cooked seafood products due to E. coli

FDA last published June 2, 2025FDA alert page

As of October 26, 2026, FDA Import Alert 16-121 (Cooked Seafood Products Due to E. Coli) lists 3 firms on its red list in 3 countries, covering cooked seafood products; 0 firms were added and 0 removed in the last 90 days.

Data from FDA public records, last checked October 26, 2026. Request a correction

3
firms on the red list: 3
countries: 0
added in the last 90 days: 0
removed in the last 90 days

What changed in the last 90 days

Additions use the date FDA published each listing. Removals are dated by the day SupplierRadar first saw the firm gone; the weekly and daily checks are described on the data sources page.

Removed from Import Alert 16-121

SupplierRadar has recorded no removals from Import Alert 16-121 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page, and on the firm's own page, the day it is found.

Added to Import Alert 16-121

No firm was added to Import Alert 16-121 in the last 90 days, as of October 26, 2026.

Firms on Import Alert 16-121, by country

3 listings in 3 countries. Each name links to the firm's FDA record history; the date is the one FDA published on the alert.

Listings by country

Import alert listings by country
Country	Red list	Total
Hong Kong	1	1
Mexico	1	1
Vietnam	1	1

Hong Kong (1)

FDA refusals from Hong Kong

Firms in Hong Kong on Import Alert 16-121
Firm	List	Products	Date published
Sun Wah Marine Products (Vietnam) Co., Ltd.Tuen Mun	Red	Clams	Sep 16, 2009

Mexico (1)

FDA refusals from Mexico

Firms in Mexico on Import Alert 16-121
Firm	List	Products	Date published
La Kalita Sc de RL de CVGuaymas	Red	Crabmeat	Oct 26, 2022

Vietnam (1)

FDA refusals from Vietnam

Firms in Vietnam on Import Alert 16-121
Firm	List	Products	Date published
Thanh An Co., Ltd.Di An District	Red	Frozen; Cooked	Sep 16, 2009

Refusal charges named on this alert

FDA's alert page names these charge codes. The counts are refusal lines FDA recorded under each charge since October 2016, for all firms, not only firms on this alert.

Charge codes named on Import Alert 16-121
Charge code	Meaning	Refusal lines since 2016
FILTHY	Filthy, putrid or decomposed substance	12,348
MFR INSAN	Insanitary manufacturing, processing or packing	3,070
INSANITARY	Prepared, packed or held under insanitary conditions	898

What the alert covers and why FDA issued it

FDA's wording, with FDA's change markers removed.

Official title: Detention Without Physical Examination of Cooked Seafood Products Due to E. Coli
Product scope: Cooked seafood products
Last published: June 2, 2025

The Division of Northeast Imports collected a sample of frozen cooked clam meat, which was analyzed by the Northeast Food and Feed Lab and revealed excessive levels of Escherichia Coli (E.Coli).
E. coli is a microbiological indicator of fecal contamination because it is commonly found in the intestines of warm-blooded animals including humans. The presence of E. coli in fish and fishery products indicates the product has been contaminated with human or animal feces and additional foodborne pathogens that can indicate a food safety hazard could be present. An effective cooking process by the manufacturer will eliminate E. coli and other pathogens. The presence of E. coli in a cooked ready-to-eat (RTE) finished product indicates that either the cooking process was inadequate or more likely fecal contamination from insanitary conditions occurred in the processing plant after cooking.

FDA Import Alert 16-121, Reason for AlertRead it on FDA

Read the rest of the reason

The Human Foods Program (HFP) may support detention without physical examination (DWPE) in instances where E. coli is found in cooked fish and fishery products. Detection of E.coli in cooked fish and fishery products is indicative of product that has been processed under insanitary conditions, thereby creating a potential threat to the health of consumers. This meets the criteria established in the Regulatory Procedures Manual (RPM), Chapter 9, Subchapter - Detention without Physical Examination (DWPE).

Listing on an import alert is FDA's notice to the firm and a fact an importer must consider in its supplier evaluation under 21 CFR 1.505. What the red, green and yellow lists mean.

Questions about Import Alert 16-121

What is Import Alert 16-121?: Import Alert 16-121, “Detention without physical examination of cooked seafood products due to E. coli”, is an FDA import alert. FDA may detain cooked seafood products from the firms on its red list without physical examination; FDA last published the alert on June 2, 2025.
Which firms are on Import Alert 16-121?: As of October 26, 2026, 3 firms are listed on Import Alert 16-121 in 3 countries; the most listings are in Hong Kong (1), Mexico (1) and Vietnam (1). The full table, grouped by country, is below on this page and every firm links to its record.
How do firms get off Import Alert 16-121?: A firm asks FDA to remove it by submitting evidence that the cause of the listing has been corrected. The Guidance section of the alert on FDA's website gives the procedure and the contact for 16-121; our guide explains the steps and the evidence FDA usually asks for.
What charge does FDA use under Import Alert 16-121?: The charge section of Import Alert 16-121 names FILTHY (filthy, putrid or decomposed substance), MFR INSAN (insanitary manufacturing, processing or packing) and INSANITARY (prepared, packed or held under insanitary conditions). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.
Which firms were added to Import Alert 16-121 recently?: No firm was added to Import Alert 16-121 in the last 90 days, as of October 26, 2026.
Which firms were removed from Import Alert 16-121 recently?: SupplierRadar has recorded no removals from Import Alert 16-121 in the last 90 days, as of October 26, 2026. A removal is shown at the top of this page and on the firm's page the day it is found.

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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.