Overview
- Warning letters dated Dec. 12 fault the retailers for continued availability of ByHeart powdered formula after the Nov. 11 expansion of the recall to all unexpired cans and single‑serve sticks.
- FDA and state teams conducted more than 4,000 store checks and found recalled product in over 175 locations across 36 states, with no new on‑shelf detections reported after Nov. 26.
- Findings included Walmart stores in 21 states from Nov. 12–26, Target locations in 20 states through Nov. 20 with a $2 promotion in Arkansas and a sale in New Hampshire despite a register block, plus Kroger in 10 states and Albertsons in 11.
- CDC counts show 51 suspected or confirmed infant botulism cases across 19 states, all requiring hospitalization, with no deaths reported.
- The FDA says the retailers failed to provide requested corrective‑action plans and warns that unresolved violations could lead to product seizures or other legal action as the investigation and testing continue.