FDA Responds to Recall Contaminated Applesauce Pouches

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FDA Continues Response to Contaminated Applesauce Pouches

Tuesday, June 25, 2024

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FDA has taken additional action related to the investigation into lead and chromium in apple cinnamon fruit puree pouches prompted by elevated blood lead levels in children in the fall of 2023. The Agency is prioritizing prevention, compliance, and surveillance activities by highlighting retailers’ responsibilities in recall situations and continuing oversight of foreign firms.
FDA issued a warning letter to Dollar Tree, Inc., because the company failed to adequately remove recalled products from its store shelves. Although the company was notified of the recall in writing on October 29, 2023, effectiveness checks showed that the recalled products remained on shelves at some stores through December 19, 2023. Further, as of the date FDA issued the warning letter, Dollar Tree had not provided the Agency with any information demonstrating sustainable corrective actions to prevent the future sale of adulterated food products.
FDA has also increased targeted screening of imported foods. Negasmart, the distributor of the cinnamon used in the contaminated applesauce pouches, has been placed on Import Alert 99-47 for products that appear to be adulterated for economic gain and Import Alert 99-42 for products contaminated with heavy metals. FDA has also placed Austrofood S.A.S., the manufacturer of the applesauce products, on Import Alert 99-42. The import alerts will help ensure these products are flagged for FDA review upon any attempt to import them into the U.S.