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The federal patulin limit was written for apple juice. This recall was applesauce.

Published September 26, 2026

Facts verified as of September 26, 2026

The only patulin number the FDA has published applies to apple juice. On September 14, a grocery cooperative recalled applesauce for exceeding "food safety limits." Which limit that was is not in the public record.

What just happened

On September 14, 2026, Wakefern Food Corp., the retailer-owned cooperative behind ShopRite, recalled 23-ounce jars of Wholesome Pantry Organic Unsweetened Apple Sauce. The FDA posted the company's announcement on September 22. The affected jars carry UPC 04119005677 and a best-by date of June 16, 2027, and were sold through ShopRite, Price Rite Marketplace, The Fresh Grocer, Gourmet Garage and Fairway Market (Wakefern announcement, posted by FDA, September 22, 2026).

The trigger was a lab result, not a complaint. According to the announcement, "routine FDA testing identified elevated patulin levels that exceed food safety limits and do not meet Wakefern's quality standards." The company said limits exist "due to potential health concerns associated with elevated exposure over time." No illnesses or injuries had been reported.

The announcement does not give the measured patulin level. It also does not name the limit the product exceeded. That second gap is the part worth reading closely.

How we got here

Patulin is a compound produced by molds that grow on bruised or damaged apples, which is how the Wakefern notice describes it. An FDA page on mold-produced compounds lists fruit, grains and cheese as foods where patulin can occur and names juice or cider made from apples as the best-known example.

International review of patulin goes back decades. In 1995, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) set a provisional maximum tolerable daily intake of 0.4 micrograms per kilogram of body weight. The committee derived it from a no-observed-effect level divided by 100. JECFA noted at the time that estimated maximum intakes, 0.2 micrograms per kilogram of body weight a day for children and 0.1 for adults, were below that figure, and cautioned that apple juice was occasionally heavily contaminated.

The FDA's own number arrived in 2001. Compliance Policy Guide Sec. 510.150, issued October 22, 2001 and last updated in November 2005, tells FDA staff to consider legal action when apple juice, apple juice concentrate or an apple juice product tests at or above 50 parts per billion, with a second analysis confirming the result. When a food contains apple juice as an ingredient, the 50 ppb applies to the juice portion.

Two details in that document matter here. The first is its legal weight. A compliance policy guide is enforcement guidance for FDA staff, and this one states that it "does not create or confer any rights" and "does not operate to bind FDA or the public." Food Standards Australia New Zealand, in a 2023 survey report, describes the U.S. figure as a non-regulatory action level.

The second is scope. The guide covers juice. Applesauce is not named in it. That FDA page says the agency "set an action level for patulin in apple juice and apple juice products" and does not mention applesauce.

So when a jar of applesauce is recalled for exceeding limits, there is no published FDA figure written for applesauce to compare it against. The agency may have applied the juice guidance, the general adulteration provisions of federal food law, or an internal threshold. We searched the recall notice, the compliance guide and FDA's page on mold-produced compounds, and none of them settles which.

Where regulators diverge

Other regulators drew the line in different places, and not always in the same direction.

The European Union is the most detailed. Commission Regulation (EU) 2023/915, in force since May 25, 2023, sets patulin maximum levels by product type. Fruit juices and nectars: 50 ppb. Spirit drinks, cider and other fermented drinks derived from apples or containing apple juice: 50 ppb. "Solid apple products placed on the market for the final consumer," a category the regulation says includes apple compote and puree: 25 ppb. Apple juice and solid apple products for infants and young children, and baby food: 10 ppb. Applesauce sits in the solid-products category. These are binding maximum levels in an EU regulation, not staff guidance.

Health Canada's List of Contaminants and Other Adulterating Substances in Foods sets 50 ppb for apple juice and unfermented apple cider, as consumed. Like the FDA figure, it covers liquids. A 2017 Health Canada proposal would move that existing limit onto a formal regulatory list.

The Codex Alimentarius figure for apple juice is also 50 ppb, according to the FSANZ report. Australia and New Zealand have no patulin maximum level at all; FSANZ says so directly in the same report.

This is a divergence in scope, not evidence that one country's applesauce is cleaner than another's. A written limit tells you where a regulator set its line. It does not tell you what products in a market without that line actually contain.

The FSANZ survey is one of the few public data sets on that question, and it covers Australia, not the U.S. FSANZ tested 299 products collected in two periods between March 2021 and February 2022. Patulin was detected in 65 percent of samples. Average levels were far lower in solid apple products (4.6 ppb) than in apple juice (28 ppb), and about 90 percent of juice samples came in under the 50 ppb Codex figure. The highest single result, 532 ppb, was in a not-from-concentrate juice.

What the label actually says

An applesauce label will not tell you its patulin level. Patulin is not an ingredient, so it never appears in the ingredient list, and no U.S. rule puts test results on the jar. The recalled product was labeled organic, which describes how it was produced. The recall shows that an organic product can still be pulled after a lab test.

What the label does carry are the two identifiers that matter for this recall: the UPC and the best-by date. If you have a 23-ounce jar of Wholesome Pantry Organic Unsweetened Apple Sauce with UPC 04119005677 and a best-by date of June 16, 2027 printed on the lid, Wakefern says to return it to the store for a refund or replacement. Its customer line is 1-800-746-7748. The company says no other products at those stores are part of the recall.

For apple juice, the one published federal number applies to what is in your glass. For applesauce, there is no published FDA figure. The EU's is 25 ppb, and 10 ppb for products meant for infants and young children.

Where PurityIQ fits

PurityIQ puts records like this in front of you at the shelf: the recall notice, the limit that exists, the limit that doesn't, and where other regulators set theirs, each linked to the document it came from. You see the record. You decide.

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