What is Import Alert 21-11?

Import Alert 21-11, “Detention without physical examination of ackees due to Hypoglycin A”, is an FDA import alert. Its listed firms are on the green list, which exempts their listed products from detention without physical examination under that alert; FDA last published the alert on April 25, 2025.

Which firms are on Import Alert 21-11?

As of October 26, 2026, 16 firms are listed on Import Alert 21-11 in 3 countries; the most listings are in Jamaica (14), Belize (1) and Haiti (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 21-11?

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 21-11; our guide explains the steps and the evidence FDA usually asks for.

What charge does FDA use under Import Alert 21-11?

The charge section of Import Alert 21-11 names 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 21-11: Detention without physical examination of ackees due to Hypoglycin A

FDA last published April 25, 2025FDA alert page

As of October 26, 2026, FDA Import Alert 21-11 (Ackees Due to Hypoglycin A) lists 1 firm on its yellow list and 15 on its green list in 3 countries, covering ackees; 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

1
firms on the yellow list: 15
firms on the green 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 21-11

SupplierRadar has recorded no removals from Import Alert 21-11 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 21-11

No firm was added to Import Alert 21-11 in the last 90 days, as of October 26, 2026.

Firms on Import Alert 21-11, by country

16 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	Yellow list	Green list	Total
Jamaica	1	13	14
Belize		1	1
Haiti		1	1

Jamaica (14)

FDA refusals from Jamaica

Firms in Jamaica on Import Alert 21-11
Firm	List	Products	Date published
Ashman Food Products Ltd.St. Catherine	Green	Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile	Sep 16, 2009
Canco LimitedSeaforth	Green	Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile	Sep 16, 2009
Central Food Packers Ltd.Central Village	Green	Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile	Sep 16, 2009
Double Deuce Jamaica, Ltd.Yallahs	Green	Canned Ackees	Mar 24, 2010
Exotic Products Jamaica LimitedDanvers Pen	Green	Canned Ackees	May 22, 2013
GK Foods & Services Limited-Grace Agro ProcessorsDenbigh	Green	Canned Ackees	Apr 11, 2022
Goshen Manufacturing & Distribution LimitedKingston	Green	Canned Ackee	Feb 15, 2023
Island Packers LimitedCLARENDON	Green	Canned Ackees	Sep 16, 2009
Norsai Enterprise Ltd.Yallahs	Yellow	Canned Ackee in brine	Jun 22, 2018
Southern Fruits & Food Processors LtdSt. Elizabeth	Green	Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile	Sep 16, 2009
Stanmark Processors Company LimitedYallahs	Green	Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile	Sep 16, 2009
Tijule Company LimitedMay Pen	Green	Canned and Frozen Ackees	Sep 16, 2009
Tripple C Manufacturing & Commodities Dist LtdSaint Catherine	Green	Ackees (canned ackees in brine)	Dec 29, 2021
West Best Foods LimitedWestmoreland	Green	Ackees (Subtropical and Tropical Fruit), Metal, Commercially Sterile	Sep 16, 2009

Belize (1)

FDA refusals from Belize

Firms in Belize on Import Alert 21-11
Firm	List	Products	Date published
Fruit Processors Ltd.Dangriga	Green	Canned Ackees	Dec 18, 2009

Haiti (1)

FDA refusals from Haiti

Firms in Haiti on Import Alert 21-11
Firm	List	Products	Date published
Antillean Canning S.A.Port-Au-Prince	Green	Canned Ackees	Jun 3, 2010

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 21-11
Charge code	Meaning	Refusal lines since 2016
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 Ackees Due to Hypoglycin A
Product scope: Ackees; all product types (raw; frozen; canned; dried; etc.). The ackee may also be referenced as "akee", "akee apple", "vegetable brain" (seso vegetal in Spanish), "akie",or "ishin"
Last published: April 25, 2025

Ackee is a tropical fruit that contains a natural heat-stable toxin, hypoglycin A. The ingestion of hypoglycin A may result in no symptoms or symptoms that range from mild (e.g., some vomiting) to severe (e.g., vomiting with profound hypoglycemia, drowsiness, muscular exhaustion, prostration, and possibly coma and death).
The toxin, hypoglycin A, is found at high levels in unripe arils (the fleshy portion of the fruit), seeds, raphe (thin membrane between the seed and the aril), and rind of ackee (roughly at a level of 1,000 parts per million (ppm). Once ackee fully ripens, the hypoglycin A drops to negligible levels in the arils and raphe, making them safe to consume (although the raphe is removed prior to packaging). However, the rind and seeds still have high levels of hypoglycin A when the fruit is fully ripe and should not be consumed. Additionally, there is the possibility that unripe ackee, ackee seeds, or ackee rind could get into finished ackee products during processing. FDA determined that canned ackee, frozen ackee, or other ackee products containing concentrations of hypoglycin A above 100 ppm have not been processed properly and that finished product may pose a health risk. This led FDA to…

FDA Import Alert 21-11, Reason for AlertRead it on FDA

Read the rest of the reason

Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act; 21 U.S.C. 342(a)(4)), a food shall be deemed adulterated if it has been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health. Canned ackee, frozen ackee, and other ackee products may be considered adulterated within the meaning of section 402(a)(4) of the FD&C Act when hypoglycin A is present in the food at levels greater than 100 ppm. See Compliance Policy Guide Sec. 550.050 Canned Ackee, Frozen Ackee, and Other Ackee Products - Hypoglycin A Toxin.

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 21-11

What is Import Alert 21-11?: Import Alert 21-11, “Detention without physical examination of ackees due to Hypoglycin A”, is an FDA import alert. Its listed firms are on the green list, which exempts their listed products from detention without physical examination under that alert; FDA last published the alert on April 25, 2025.
Which firms are on Import Alert 21-11?: As of October 26, 2026, 16 firms are listed on Import Alert 21-11 in 3 countries; the most listings are in Jamaica (14), Belize (1) and Haiti (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 21-11?: 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 21-11; our guide explains the steps and the evidence FDA usually asks for.
What charge does FDA use under Import Alert 21-11?: The charge section of Import Alert 21-11 names 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 21-11 recently?: No firm was added to Import Alert 21-11 in the last 90 days, as of October 26, 2026.
Which firms were removed from Import Alert 21-11 recently?: SupplierRadar has recorded no removals from Import Alert 21-11 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.