California-based Initiative Foods is recalling one lot of fruit puree baby food due to elevated levels of mold toxin patulin, the company said in a recent announcement published by the Food and Drug Administration.
The recall applies to “Tippy Toes Apple Pear Banana” puree packaged in two-pack plastic tubs with lot number 07174 and a “Best By” date of July 17, 2026, according to the company. The item was distributed in retail grocery outlets across all U.S. states, except for Alaska, and potentially in Puerto Rico and Guam.
“Patulin is a naturally occurring substance (called a mycotoxin) which is produced by molds that may grow in various fruits, including apples,” the Feb. 13 statement said.
“Long-term exposure resulting from ingestion of patulin can lead to various adverse health consequences, including a potential for immune suppression, nerve damage, headache, fever, and nausea.”
The agency said that no illness or injuries have been reported so far.
A study conducted by the FDA sampled the product and found patulin at levels higher than usual in these items, the announcement said.
Initiative Foods asked consumers who have bought the recalled product to discontinue use, dispose of the item, or return it to the place of purchase for a refund. The company advised consumers to get in touch with a health care provider in case health concerns arise after eating the recalled item.
Retailers were asked to check their inventory and to quickly remove the affected products from distribution.
“At Initiative Foods, the safety of our consumers and their families is our highest priority. We are cooperating with the FDA to ensure strict review and enhanced safety measures across all our products,” Don Ephgrave, CEO and president of Initiative Foods, said in a statement.
“We thank our retail partners and customers for their understanding and prompt action on this matter.”
The Epoch Times reached out to Initiative Foods for comment but did not receive a response by publication time.
According to a September 2024 post from the FDA, the agency has a monitoring program in place aimed at ensuring that foods made available to consumers are free from mycotoxins. The FDA focuses on several mycotoxins, including patulin.
Patulin is produced by molds such as aspergillus and penicillium that grow on grains, fruit, and cheese. Following proper harvest and storage practices, such as removing rotten portions of a fruit, can prevent or greatly minimize patulin contamination in food products.
Fermentation is another way to prevent the presence of patulin in food items. As such, the toxin is usually not found in alcohol or vinegar made from fruits susceptible to mold growth, according to the FDA.
“The risk of patulin contamination increases when companies use moldy apples to make apple juice. Pasteurization won’t get rid of patulin. Drinking the contaminated apple juice can cause nausea, vomiting, and possibly damage the DNA in some body cells,” the agency said.
Multiple recalls citing mold contamination in food products have been issued in recent years.
In October 2024, Minnesota-based Lunds & Byerlys recalled roughly 500 containers of L&B Lone Star sweet and tangy dips due to this issue.
According to a 2022 study published in the International Journal of Chemical Studies, patulin levels above certain thresholds negatively affect the entire population, regardless of gender, age, or race.
When it comes to risks of patulin exposure, nursing infants are a “vulnerable” category, the study said. Patulin intake by the mother may end up pushing up the toxin level in breast milk beyond the tolerated daily intake limit for infants, even if the mother’s exposure to the toxin is within the adult limits.
According to the FDA’s compliance policy on patulin presence in apple juice and related products, one of the criteria that can trigger regulatory action is if the toxin level in these products is shown to be present at or above 50 micrograms per kilogram.
