Update: Investigation of Elevated Lead & Chromium Levels: Cinnamon Applesauce Pouches

The FDA has transitioned from its initial response activities managed by FDA’s Coordinated Outbreak Response & Evaluation (CORE) Network, to contain the event so that no additional illnesses occurred and to identify the source of the issue.

The agency is now focused on post-incident response actions and activities, which may include additional surveillance, as well as prevention and compliance activities.

During the course of this investigation, CORE received 90 confirmed complaints/reports of adverse events potentially linked to recalled product. There is a lag between exposure to lead, the development of any noticeable symptoms/routine screening to detect elevated blood lead levels, and the determination of the likely source of exposure and reporting that to CDC and FDA.

Although FDA may receive additional complaints/adverse event reports related to this product, they will no longer report them on their response page; however, FDA will continue to evaluate any incoming adverse events and conduct follow up as needed.