Total FDA Adverse Events: 57
Report Date Ranges: October 17, 2023 – November 28, 2023
States with Adverse Illness Events: AL (1), AR (1), CA (1), CT (1), FL (1), GA (2) IA (1), IL (2), KY (3), LA (4), MA (3), MD (4), MI (3), MO (1), NC (5), NE (1), NH (1), NM (1), NY (8), OH (2), PA (1), SC (2), TN (1), TX (3) VA (1), WA (3)
Product Distribution: Nationwide
FDA, along with CDC and state and local partners, is investigating reports of elevated blood lead levels in individuals with reported exposure to Apple Cinnamon Fruit Puree pouches manufactured in Ecuador and sold under WanaBana, Weis, and Schnucks brands.
- WanaBana apple cinnamon fruit puree pouches are sold nationally and are available through multiple retailers including Amazon, Dollar Tree, and other online outlets.
- FDA is aware that recalled WanaBana Apple Cinnamon Puree is still on the shelves at several Dollar Tree stores in multiples states. This product should not be available and consumers should not purchase this product.
- Schnucks-brand cinnamon-flavored applesauce pouches and variety pack are sold at Schnucks and Eatwell Markets grocery stores.
- Weis-brand cinnamon applesauce pouches are sold at Weis grocery stores.
As of November 22, 2023, there have been 52 reports of adverse events potentially linked to recalled product submitted to FDA. To date, confirmed complainants are less than 1 to 4 years of age. FDA is continuing to evaluate incoming adverse event reports.
FDA is aware that recalled WanaBana Apple Cinnamon Puree is still on the shelves at several Dollar Tree stores in multiple states. FDA is working with the firm to ensure an effective recall. This product should not be available for sale and consumers should not purchase or consume this product as it is potentially contaminated with lead, which can be harmful to health, particularly for children.
To properly discard the product, consumers and retailers should carefully open the pouch and empty the content into a trash can before discarding the packaging to prevent others from salvaging recalled product from the trash. Clean up any spills after discarding the product then wash your hands.
FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, the FDA is not aware of any other reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon.
FDA and other state partners collected and analyzed additional product samples of fruit puree and applesauce pouches. FDA detected elevated levels of lead in one finished product sample of WanaBana Apple Cinnamon Puree collected from Dollar Tree. The level detected in the FDA sample of WanaBana apple cinnamon puree is 2.18 parts per million (ppm), which, for context, is more than 200 times greater than the action level the FDA has proposed in draft guidance for fruit purees and similar products intended for babies and young children.
FDA’s leading hypothesis is that cinnamon used in these recalled pouches is the likely source of contamination for these products; however, the FDA has not yet been able to collect and test samples of the cinnamon used in the recalled products. The FDA is continuing to work with Ecuadorian authorities to investigate the source of the cinnamon. At this time, FDA has no indication that this issue extends beyond these recalled products, but to further protect public health, FDA is screening incoming shipments of cinnamon from multiple countries for lead contamination.
In addition to determining the source of cinnamon, FDA’s investigation is ongoing to determine the point of contamination and whether additional products are linked to illnesses. At this time, the FDA is not aware of any other reports of illnesses or elevated blood lead level adverse events reported for other cinnamon-containing products or cinnamon.
The FDA also reminds industry that it is the legal responsibility of companies distributing food products that are sold in the U.S., to comply with applicable requirements in the Federal Food, Drug, and Cosmetic Act and FDA’s regulations.
By law, food manufacturers have a responsibility to significantly minimize or prevent chemical hazards when needed. This includes putting in place any needed preventive controls to reduce or eliminate the presence of lead in their products. Most food manufacturers and processors are covered by the preventive control provisions of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule. The preventive control provisions require industry to implement controls to significantly minimize or prevent any identified chemical hazards, such as lead, requiring a control. In addition, some manufacturers may conduct verification activities like testing the final product.
For more information please see FDA’s Draft Guidance for Industry on Hazard Analysis and Risk-Based Preventive Controls for Human Food.