Investigation of elevated lead levels in Cinnamon Applesauce Pouches (November 2023)

The FDA reported on October 28, 2023, with the North Carolina Department of Health and Human Services (NCDHHS) and the North Carolina Department of Agriculture & Consumer Services (NCDA&CS) that they are investigating reports of 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 lead concentrations. The FDA has reviewed and supported NCDHHS's analytical findings and determined that levels of lead found in the analyzed pouches could result in acute lead toxicity. As of November 13, 2023, 22 reports of illness are potentially linked to recalled products. As part of this investigation, FDA and state partners are collecting and analyzing additional product samples of fruit puree and applesauce pouches. Currently, sample analyses have not shown elevated lead levels in non-recalled products. States with Adverse Illness Events: AL (1), AR (1), LA (2), MD (1), MO (1), NC (5), NM (1), NY (2), OH (1), PA (1), SC (2), TN (1), TX (1) WA (1), Unknown (1). On October 31, 2023, Wanabana LLC initiated a recall of all WanaBana Apple Cinnamon Fruit Puree Pouches. On November 9, 2023, Wanabana LLC's recall was expanded to include information on recalled Schnucks and Weis cinnamon applesauce pouches. The recall impacts markets outside the United States, including Cuba and the United Arab Emirates. WanaBana apple cinnamon fruit puree pouches are sold nationally and are available through multiple retailers, including Amazon, Dollar Tree, and other online outlets. Schnucks-brand cinnamon-flavored applesauce pouches and variety packs are sold at Schnucks and Eatwell Markets grocery stores. Weis brand cinnamon applesauce pouches are sold at Weis grocery stores.@ https://www.fda.gov/food/outbreaks-foodborne-illness/investigation-elevated-lead-levels-cinnamon-applesauce-pouches-november-2023?utm_medium=email&utm_source=govdelivery