Dollar Tree Inc. – FDA Warning Letter, Dec 19, 2023

The FDA, CDC, and state partners investigated elevated lead levels in WanaBana Apple Cinnamon Fruit Puree pouches starting October 2023, finding extremely high concentrations that render the products adulterated under FD&C Act section 402(a)(1). Lead exposure from these products poses a significant health risk, particularly to children. Following Wanabana USA's voluntary recall on October 29, 2023, Dollar Tree Inc., as a consignee, was notified. However, subsequent FDA recall audit checks revealed Dollar Tree continued to offer the recalled products on store shelves for weeks and months, violating FD&C Act section 301(c) by receiving and delivering adulterated food. The recall was deemed ineffective at the retail level due to Dollar Tree's failure to adequately remove products, with many stores reportedly not notified by headquarters. Despite numerous FDA communications and calls through December 2023, recalled products persisted on shelves. Dollar Tree has also failed to provide information on long-term, sustainable corrective actions to prevent future occurrences. The firm must respond within 15 working days detailing specific steps taken to address violations and prevent recurrence, or face potential legal action, including seizure and injunction.