What is Import Alert 41-03?

Import Alert 41-03, “Detention without physical examination of adulterated and misbranded medical foods”, is an FDA import alert. FDA may detain medical foods from the firms on its red list without physical examination; FDA last published the alert on December 10, 2020.

Which firms are on Import Alert 41-03?

As of October 26, 2026, 2 firms are listed on Import Alert 41-03 in 2 countries; the most listings are in Mexico (1) and South Africa (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 41-03?

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 41-03; our guide explains the steps and the evidence FDA usually asks for.

What charge does FDA use under Import Alert 41-03?

The charge section of Import Alert 41-03 names MFR INSAN (insanitary manufacturing, processing or packing) and FALSE (false or misleading labeling). Each code is a refusal charge in FDA's reference table; the linked pages give FDA's official statement and refusal counts.

Import Alert 41-03: Detention without physical examination of adulterated and misbranded medical foods

FDA last published December 10, 2020FDA alert page

As of October 26, 2026, FDA Import Alert 41-03 (Adulterated and Misbranded Medical Foods) lists 2 firms on its red list in 2 countries, covering medical foods; 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

2
firms on the red list: 2
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 41-03

SupplierRadar has recorded no removals from Import Alert 41-03 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 41-03

No firm was added to Import Alert 41-03 in the last 90 days, as of October 26, 2026.

Firms on Import Alert 41-03, by country

2 listings in 2 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
Mexico	1	1
South Africa	1	1

Mexico (1)

FDA refusals from Mexico

Firms in Mexico on Import Alert 41-03
Firm	List	Products	Date published
Rubio de B.C., S.A. de C.V.Mexicali	Red	Electrolit Coconut; Electrolit Apple; Electrolit Grapefruit; Electrolit Strawberry; Electrolit Peach	Apr 18, 2014

South Africa (1)

FDA refusals from South Africa

Firms in South Africa on Import Alert 41-03
Firm	List	Products	Date published
Sunspray Food Ingredients (Pty) LtdJohannesburg	Red	Ketovolve 4;1 Ratio Powder	Nov 22, 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 41-03
Charge code	Meaning	Refusal lines since 2016
MFR INSAN	Insanitary manufacturing, processing or packing	3,070
FALSE	False or misleading labeling	2,446

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 Adulterated and Misbranded Medical Foods
Product scope: Medical Foods
Last published: December 10, 2020

In general, medical foods are analogous to infant formulas, in that the technology base is similar for the manufacture of both products. Adulterated medical foods may constitute short and long-term health hazards to the susceptible populations who consume these products. Potential health hazards associated with medical foods include compositional errors that result in microbiological and/or environment contamination. For this reason, the Center has identified medical foods as a high-risk food category. Therefore, the Agency is committed to assuring the continued safety and integrity of medical foods through annual inspection of all manufacturers of such products and routine analyses of medical food products.
A firm may be listed on the Red List either because the most recent FDA inspection conducted at the plant revealed that the plant was not following 21 CFR 110 or was otherwise preparing, packing, or holding products under insanitary conditions whereby such products may have been rendered injurious to health, and/or because one or more products manufactured at the plant have been analyzed by FDA and classified as violative.

FDA Import Alert 41-03, Reason for AlertRead it on FDA

Read the rest of the reason

In addition, a firm may be listed on the Red List because the label misstates the active amount of an ingredient. For example, FDA analysis of a medical food marketed as a low carbohydrate product revealed that the product may contain as much as 11 grams of carbohydrate instead of the labeled 3 grams. Because the label misstates the actual amount of carbohydrate in the product, this also results in a significantly lower fat: carbohydrate + protein ratio than what is stated on the label.

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 41-03

What is Import Alert 41-03?: Import Alert 41-03, “Detention without physical examination of adulterated and misbranded medical foods”, is an FDA import alert. FDA may detain medical foods from the firms on its red list without physical examination; FDA last published the alert on December 10, 2020.
Which firms are on Import Alert 41-03?: As of October 26, 2026, 2 firms are listed on Import Alert 41-03 in 2 countries; the most listings are in Mexico (1) and South Africa (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 41-03?: 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 41-03; our guide explains the steps and the evidence FDA usually asks for.
What charge does FDA use under Import Alert 41-03?: The charge section of Import Alert 41-03 names MFR INSAN (insanitary manufacturing, processing or packing) and FALSE (false or misleading labeling). 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 41-03 recently?: No firm was added to Import Alert 41-03 in the last 90 days, as of October 26, 2026.
Which firms were removed from Import Alert 41-03 recently?: SupplierRadar has recorded no removals from Import Alert 41-03 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.