FDA Actions: public health alert

The FDA is issuing this public health alert informing parents and caregivers not to buy or feed WanaBana apple cinnamon fruit puree pouches to toddlers and young kids because they may have elevated levels of lead. The FDA is continuing to work with state officials and the firm, collecting additional information, and taking steps to remove all contaminated products from the market.

Short-term exposure to lead could result in the following symptoms: HeadacheAbdominal pain/Colic Vomiting and Anemia.

Longer-term exposure could result in additional symptoms: Irritability Lethargy Fatigue Muscle aches or muscle prickling/burning Occasional abdominal discomfort Constipation Difficulty concentrating/Muscular exhaustibility Headache Tremors and Weight loss.

Summary of Problem and Scope

The FDA was recently made aware of a developing investigation by the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) regarding four children with elevated blood lead levels, indicating potential acute lead toxicity.

The NCDHHS investigation identified WanaBana apple cinnamon fruit puree pouches as a potential shared source of exposure. As part of their investigation, NCDHHS analyzed multiple lots of WanaBana apple cinnamon fruit puree, detecting extremely high concentrations of lead. The FDA has reviewed and supported NCDHHS’s analytical findings and found that analytical results at this level could result in acute toxicity. The FDA has shared the results with the firm whose representatives are cooperating with the FDA and have agreed to voluntarily recall all WanaBana apple cinnamon fruit puree pouches regardless of expiration.