In late October 2023, the U.S. Food and Drug Administration (FDA) was alerted by the North Carolina Department of Health and Human Services (NCDHHS) to reports of children with high blood lead levels (BLLs), which NCDHHS linked to the consumption of WanaBana Apple Cinnamon Fruit Puree pouches after finding elevated levels of lead in the product. On November 13, 2023, the U.S. Centers for Disease Control and Prevention (CDC) posted an alert about the food safety incident's impact on public health. As of November 22, 2023, there are 52 known cases of acute lead poisoning potentially linked to the puree pouches.
FDA testing revealed WanaBana puree samples to contain lead at a level of 2.18 parts per million (ppm), which is more than 200 times greater than the action level FDA has proposed in a draft guidance for fruit purees and similar products intended for babies and young children.