Overview
- Warning letters dated Dec. 12 cite findings that recalled ByHeart powdered infant formula remained available for purchase days to weeks after the Nov. 11 expansion of the recall.
- Inspectors and state officials documented recalled stock at Walmart stores in 21 states (Nov. 12–26), Target in 20 states (including a posted $2 discount and one recorded sale on Nov. 16), Kroger in 10 states, and Albertsons in 11 states.
- The CDC reports 51 infant illnesses across 19 states linked to the outbreak; all affected babies were hospitalized and treated, and symptoms can appear weeks after exposure.
- ByHeart first recalled select lots on Nov. 8 and expanded to all powdered cans and single‑serve packs on Nov. 11, with regulators continuing inspections and product testing.
- FDA said the retailers had not provided adequate evidence of fixes despite follow‑ups and reminded them that failure to prevent sales of recalled products could trigger enforcement actions.