The slow response of major retailers to remove recalled ByHeart infant formula is endangering children across the nation.
Story Highlights
- Retailers failed to promptly remove ByHeart formula despite FDA recall.
- The recall involves potential infant botulism, a rare but serious illness.
- 51 infants across 19 states are affected as of December 10, 2025.
- FDA and CDC continue to investigate the source of contamination.
Retailers Criticized for Slow Recall Response
The FDA has criticized major retailers for failing to promptly remove ByHeart Whole Nutrition infant formula from their shelves, despite a full recall issued on November 11, 2025. This delay has resulted in 51 confirmed cases of infant botulism across 19 states. Retailers such as Walmart, Target, and Kroger have been under scrutiny as their slow response has raised serious concerns over infant safety.
Infant botulism, caused by the *Clostridium botulinum* bacterium, is a rare but severe illness that can lead to muscle weakness and, in some cases, death. The FDA’s recall was triggered by positive samples found in California, prompting a nationwide recall of all ByHeart infant formula products. Despite these efforts, the recalled products continued to appear on store shelves, risking further infant illnesses.
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The Ongoing Investigation
The Centers for Disease Control and Prevention (CDC) has expanded the case definition to include any botulism exposure linked to ByHeart formula since its launch in March 2022. The source of contamination remains unidentified, and the FDA’s investigation is ongoing. ByHeart, the manufacturer, has cooperated with the recall and is conducting its internal tests to identify the contamination source.
The FDA and CDC have urged parents to cease using ByHeart formula products immediately. Meanwhile, the manufacturers have acknowledged the FDA’s alert of approximately 83 cases since August 2025, leading to the comprehensive recall.
Impact on Consumers and the Industry
The recall has significant implications for consumers and the broader infant formula industry. In the short term, it poses a risk of additional botulism cases and necessitates urgent formula switches for affected families. In the long term, it highlights potential manufacturing reforms and has eroded trust in the ByHeart brand.
Retailers didn't pull ByHeart baby formula fast enough after botulism recall, FDA says https://t.co/zX1fHs5cIe
— Ideastream News (@Ideastream) December 16, 2025
The economic impact includes recall costs for ByHeart and retailers, alongside potential formula shortages. Politically, the incident has led to increased scrutiny on FDA oversight and retailer accountability, pushing for stricter enforcement of recall procedures and improvements in supply chain vigilance.
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Sources:
Outbreak Investigation of Infant Botulism: Infant Formula – November 2025 (FDA primary reporting)
ByHeart’s Response to FDA Investigation
CDC’s Botulism Outbreak Investigations
ByHeart’s Open Letter to the FDA
