Overview
- Warning letters dated Dec. 12 cite failures to promptly remove ByHeart formula after a November recall that was expanded to all products three days after it began.
- FDA and partners conducted more than 4,000 store checks and found recalled products in over 175 locations across 36 states, including a Target with a $2 sale sign on single-serve packs.
- The retailers have 15 working days to detail corrective actions, and the FDA says noncompliance could lead to legal steps such as seizures or injunctions.
- The CDC reports 51 infants from 19 states have been hospitalized in a botulism outbreak linked to ByHeart formula, with no deaths reported and the investigation ongoing.
- Officials are testing unopened samples and auditing facilities, while retailers say they removed products and some store workers cited confusion and recall‑identification issues.