Archive · 16 Dec 2025
FDA Warns Retailers Over Delayed ByHeart Formula Recall
The FDA sent warning letters to four big retailers—Walmart, Target, Kroger, and Albertsons—because they didn't quickly remove baby formula from their stores after a recall.
The formula, made by ByHeart, was linked to a botulism outbreak that made over 50 babies sick in 19 states.
The recall started on November 11, but the formula was still sold for days or even weeks after that.
The FDA also said the retailers didn't show they had fixed the problem.
The FDA itself was slow to share recall details with state officials, which made the situation worse.
The retailers say they did their best to remove the formula, but the FDA wants them to explain what happened.
All the babies who got sick were treated in the hospital.
FDA sent warning letters to Walmart, Target, Kroger, and Albertsons for failing to promptly remove recalled ByHeart baby formula linked to a botulism outbreak.
The recall was initiated on November 11, 2023, but the formula was still sold for days or weeks afterward at various stores.
Over 50 babies in 19 states were sickened by the contaminated formula, all of whom were hospitalized and treated.
The FDA criticized the retailers for not providing evidence of corrective actions and gave them 15 working days to respond.
The FDA also acknowledged its own delay in sharing recall information with state and local officials, which may have contributed to the problem.
- Who
- Walmart, Target, Kroger, Albertsons, FDA, ByHeart
- What
- FDA warns retailers for delayed recall of contaminated ByHeart baby formula linked to botulism outbreak
- When
- Recall initiated on November 11, 2023; FDA warning letters sent on December 12, 2023
- Where
- United States, with formula found in 20+ states across various retailers
- Why
- Retailers failed to promptly remove recalled formula from shelves, and FDA delayed sharing recall information
- Retailers Involved
- Walmart, Target, Kroger, Albertsons
- Recall Date
- November 11, 2023
- Number of Babies Sickened
- More than 50
- States Affected
- 19 states
- FDA Warning Letters Sent
- December 12, 2023
- FDA Response Deadline
- 15 working days from December 12, 2023
- FDA Information Sharing Delay
- November 14, 2023 (6 days after initial recall)