What does PATULIN mean on an FDA refusal?

PATULIN is the refusal charge “Appears to contain Patulin, a poisonous and deleterious substance which may render it injurious to health.”. FDA's official statement for the charge reads: “The article is subject to refusal of admission pursuant to Section 801(a) (3) of the Act, in that it appears to contain Patulin, a poisonous and deleterious substance which may render it injurious to health.”

What law does PATULIN cite?

FDA's refusal charge table cites sections 402(a)(1) and 801(a)(3) of the FD&C Act (adulteration) for PATULIN, and classifies the charge as adulteration. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.

Which countries have the most PATULIN refusals?

As of October 26, 2026, the countries with the most PATULIN refusal lines are Argentina (2) and Australia (1). The full list with links is in the table on this page.

Is there an FDA import alert for PATULIN?

SupplierRadar found no food import alert whose charge section names PATULIN. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

FDA refusal charge

FDA refusal charge PATULIN

Appears to contain Patulin, a poisonous and deleterious substance which may render it injurious to health.

PATULIN is the FDA import refusal charge for appears to contain Patulin, a poisonous and deleterious substance which may render it injurious to health.; it cites sections 402(a)(1) and 801(a)(3) of the FD&C Act (adulteration). FDA recorded it on 3 refused shipment lines from 2 countries between October 2016 and January 8, 2021, most often for berries and citrus from Argentina.

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

3
refused shipment lines carry this charge: 2
countries of origin: 0
import alerts name this charge

What PATULIN means

SupplierRadar has not written a plain-English version of PATULIN yet. FDA's own statement is quoted below.

FD&C Act section: 402(a)(1)801(a)(3)
Classification: adulteration

FDA's official statement

Copied unchanged from FDA's Refusal Charges reference table.

The article is subject to refusal of admission pursuant to Section 801(a) (3) of the Act, in that it appears to contain Patulin, a poisonous and deleterious substance which may render it injurious to health.

PATULIN · 402(a)(1), 801(a)(3); ADULTERATIONFDA reference table (CSV)

Countries with the most PATULIN refusals

Shipment lines carrying PATULIN, by country of origin.

PATULIN refusal lines by country
Country	Lines	Share of PATULIN
Argentina	2	67%
Australia	1	33%

Product categories with the most PATULIN refusals

PATULIN refusal lines by product category
Category	Lines	Share of PATULIN
Fruit and Fruit Products (berries, citrus and core fruits)	3	100%

Latest PATULIN refusals

The 3 most recent refused lines, through January 8, 2021, each with its FDA source.

Latest FDA refusals carrying PATULIN
Date	Firm	Product	Charges
Jan 8, 2021	Jugos Luga S.A.Mainque, Argentina	Apple, core fruit juices or concentrates	PATULIN	Source
Jan 8, 2021	Jugos Luga S.A.Mainque, Argentina	Apple, core fruit juices or concentrates	PATULIN	Source
Oct 23, 2017	Sunraysia Five Star (Global)South Melbourne, Australia	Apple, core fruit juices or concentrates	PATULIN	Source

Questions about PATULIN

What does PATULIN mean on an FDA refusal?: PATULIN is the refusal charge “Appears to contain Patulin, a poisonous and deleterious substance which may render it injurious to health.”. FDA's official statement for the charge reads: “The article is subject to refusal of admission pursuant to Section 801(a) (3) of the Act, in that it appears to contain Patulin, a poisonous and deleterious substance which may render it injurious to health.”
What law does PATULIN cite?: FDA's refusal charge table cites sections 402(a)(1) and 801(a)(3) of the FD&C Act (adulteration) for PATULIN, and classifies the charge as adulteration. The table is the Refusal Charges reference file that FDA publishes with its Data Dashboard.
Which countries have the most PATULIN refusals?: As of October 26, 2026, the countries with the most PATULIN refusal lines are Argentina (2) and Australia (1). The full list with links is in the table on this page.
Is there an FDA import alert for PATULIN?: SupplierRadar found no food import alert whose charge section names PATULIN. An import alert is a list of firms; a charge code is the reason recorded on one refused shipment line.

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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.