FDA inspecting plant in Ecuador in applesauce lead situation; more children reported sick

Federal officials have begun an onsite inspection of a company in Ecuador that exported cinnamon applesauce to the United States that was used in three brands of applesauce traced to an outbreak of lead poisoning in children.

The Food and Drug Administration is conducting the inspection at the Austrofoods facility located in Ecuador. Cinnamon samples collected from the lots used in recalled products will undergo laboratory analysis. FDA will update the U.S. public to share the sample results once the analysis is complete. 

Federal officials have received a total of 125 reports of cases of lead poisoning from 22 different states through their reporting structure. Three brands of cinnamon applesauce pouches designed for children have been recalled; Wanabana, Schnucks and Weis. The Wanabana brand is sold at retailers nationwide and online. The FDA has received reports that the recalled applesauce is still on shelves at Dollar Tree stores. The Schnucks and Weis brand applesauce was sold at those regional grocery store chains and has been removed from stores.  

Anyone with the recalled applesauce on hand is urged to not feed it to children or eat it themselves. Some of the recalled applesauce has been found to have 500 times the recommended amount of lead in it.

Parents and caretakers should consult a healthcare provider if they suspect a child may have been exposed to lead. Short term exposure to lead could result in the following symptoms: headache; abdominal pain/colic; vomiting; anemia. Longer term exposure could result in the following additional symptoms: irritability; lethargy; fatigue; muscle aches or muscle prickling/burning; constipation; difficulty concentrating/muscular weakness; tremor; weight loss. Permanent consequences can lead to developmental delays and brain damage.

To date, the FDA has worked with Ecuadorian authorities to gather information about Negasmart, the supplier of cinnamon to Austrofoods, including whether the cinnamon in the recalled products was used in other products exported to the United States. Working together with Ecuadorian authorities, the FDA has confirmed that, of Negasmart’s direct customers, only Austrofoods ships product to the US. In addition, the FDA has confirmed that Negasmart does not directly export products to the US. 

As of Dec. 11, 2023, FDA has received 65 reports of adverse events potentially linked to recalled product. To date, confirmed complainants, or people for whom an adverse event was submitted, are younger than 6 years of age. 

The U.S. Centers for Disease Control and Prevention’s National Center for Environmental Health is conducting case finding efforts in collaboration with state and local health departments. The CDC’s case definition for state partners includes a blood lead level of 3.5 µg/dL or higher measured within 3 months after consuming a recalled WanaBana, Schnucks, or Weis brand fruit puree product after Nov. 2022. As of Dec. 8, CDC has received reports of 46 confirmed cases, 68 probable cases, and 11 suspected cases for a total of 125 cases from 22 different states through their reporting structure. For more information, please visit CDC’s page to review their case reporting methodology and findings.

CDC and FDA have different data sources, so the counts reported by each agency will not directly correspond. In addition, some people who were affected by the contaminated product might be reflected in both the numbers reported by the FDA and the numbers reported by CDC, so the numbers should not be added together.

FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses.

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