Patulin in Baby Food: What the 2026 Tippy Toes Recall and FDA Warning Letter Mean

The short answer

Patulin is a toxin made by molds that can grow on apples and other fruits [1][3]. In February 2026 one lot of Tippy Toes Apple Pear Banana puree was recalled after FDA testing found elevated patulin [2]. An FDA warning letter posted in November says the maker did not treat patulin as a hazard needing preventive controls [1][4]. The letter does not announce a new recall [4].

This is general information, not medical advice. Talk to your pediatrician if you are worried about your child.

What is patulin?

Patulin is a mycotoxin, a toxic substance produced by molds. FDA describes it as a toxin from molds that may grow on apples [3], and its warning letter calls patulin in apple-containing products "a well-recognized food safety hazard" [1]. The recall notice says the molds may grow in various fruits, including apples [2].

The recall notice lists possible effects of long-term exposure: immune suppression, nerve damage, headache, fever and nausea [2]. News coverage of the warning letter notes that a single serving is not expected to cause those effects; the concern is repeated exposure over time in a small body [4].

What happened with the Tippy Toes recall?

On February 13, 2026, IF Copack LLC, doing business as Initiative Foods, recalled one lot of Tippy Toes Apple Pear Banana fruit puree [2]:

Detail	Recalled product [2]
Product	Tippy Toes Apple Pear Banana, 2-pack plastic tubs
Lot / best by	Lot 07174, "BB 07/17/2026"
UPC	036800 265783
Package code	INIA0120
Distribution	Retail stores in all U.S. states except Alaska; possibly Guam and Puerto Rico
Illnesses	None reported

The problem was found through FDA's Total Diet Study, a non-regulatory sampling program, which found patulin levels higher than is common for these products [1][2]. The company then tested retained samples, and a private lab found 40 ppb patulin in one lot [1]. The recall was done on FDA's recommendation [2].

What did FDA's 2026 warning letter find?

FDA inspected the company's Sanger, California plant from March 31 to April 9, 2026, and sent a warning letter dated September 29, 2026 [1]; it was posted publicly on November 3 [4]. FDA said [1]:

• The hazard analysis for its fruit and vegetable pouches did not identify patulin as a hazard requiring a preventive control, and rated it as low likelihood.
• The plant had no patulin specifications for incoming fruit ingredients.
• It received certificates of analysis (COAs) with patulin results for some ingredients, but there was no record that they were reviewed as a safety control.
• On December 26, 2025, it used an ingredient lot whose COA had no patulin result at all, with no record the gap was caught.

These are the kinds of supply-chain controls FDA's preventive controls rule expects; see our explainer on FDA's Chapter 12 chemical hazards guidance.

Is there an FDA limit for patulin in baby food?

FDA's published patulin action level is written for apple juice. Under Compliance Policy Guide 510.150, FDA may take action when apple juice, juice concentrate or a product containing apple juice has patulin at or above 50 micrograms per kilogram (50 ppb), measured on the single-strength juice [3].

FDA first proposed this action level in a June 2000 Federal Register notice, which said patulin had been found at high levels in some apple juice products sold or imported in the United States and that the scientific basis for the 50 ppb level was set out in a supporting document [5]. The guide was issued in 2001 [3].

The recall notice and warning letter do not cite a separate numeric patulin limit for fruit purees [1][2]. They describe the Tippy Toes lot as having patulin "higher than is common" for these products [2].

Are other baby foods affected?

Not according to the warning letter. Initiative Foods also makes baby food for store brands, but news coverage notes the letter does not say any other product contains elevated patulin, and no new recall has been announced [4]. Only the single Tippy Toes lot above was recalled [2].

What can parents do?

• Check the lot. If you still have Tippy Toes Apple Pear Banana tubs with lot 07174 and "BB 07/17/2026", throw them away or return them for a refund [2].
• Rotate fruits. Offering a variety of fruits and vegetables rather than relying mainly on apple-based purees spreads exposure across foods [4]; see homemade vs store-bought baby food.
• Skip damaged packs. Avoid packages that are swollen, leaking or past their date [4].
• Limit juice. Apple juice is the product FDA's patulin level targets [3]; see fruit juice for toddlers.
• Ask your pediatrician if your child ate the recalled lot and you have concerns [2].

For another 2026 spice-and-puree food safety issue, see lead in cinnamon and baby food.

FAQ

Is patulin the same as a heavy metal?

No. Patulin is a mycotoxin made by molds [3]. Lead, arsenic, cadmium and mercury are metals; see our lead vs cadmium comparison.

Was anyone made ill by the Tippy Toes puree?

No illnesses or injuries were reported, according to the recall notice [2].

Does cooking or making my own apple puree remove patulin?

Our sources do not say. The FDA documents cited here focus on controlling patulin through ingredient specifications and testing [1][3]. Rotating fruits, rather than relying mainly on apple, still spreads exposure [4].

Why did FDA send a warning letter if only one lot was recalled?

The letter is about the plant's food safety system, not a new product finding. FDA said patulin was not identified as a hazard needing controls and ingredient test certificates were not reviewed [1].

Which apple products does FDA's 50 ppb level cover?

Apple juice, apple juice concentrate and foods containing apple juice as an ingredient, measured on the single-strength juice [3].

References

1. U.S. FDA, Warning Letter: IF Co-Pack, LLC dba Initiative Foods, MARCS-CMS 732244 (September 29, 2026).
2. U.S. FDA, IF Copack LLC dba Initiative Foods Recalls "Tippy Toes" Brand Apple Pear Banana Because of Possible Health Risk (February 13, 2026).
3. U.S. FDA, CPG Sec. 510.150 Apple Juice, Apple Juice Concentrates, and Apple Juice Products – Adulteration with Patulin.
4. Medical Daily, Tippy Toes Baby Food Maker Lacked Preventive Controls for Mold Toxin Patulin Before February Fruit Puree Recall (November 6, 2026).
5. Federal Register, Apple Juice, Apple Juice Concentrates, and Apple Juice Products – Adulteration with Patulin; Draft Compliance Policy Guide; Availability (65 FR 37791, June 16, 2000).