Los Angeles, December 19, 2025
The FDA has issued warning letters to major retailers, including Target and Walmart, for failing to promptly remove ByHeart Whole Nutrition Infant Formula from shelves after a botulism outbreak. At least 51 infants have been affected, highlighting the critical responsibility of retailers to ensure the safety of products for vulnerable populations like infants. The FDA has demanded corrective actions within 15 working days or face potential legal repercussions. Parents are advised to check for recalled formula and consult healthcare providers if symptoms arise.
FDA Warns Major Retailers Over Botulism-Linked Infant Formula
Retail Giants Face Scrutiny After ByHeart Nutritional Formula Recall
Los Angeles, CA – The U.S. Food and Drug Administration (FDA) has recently issued warning letters to major retailers, including Target and Walmart, for their failure to promptly remove ByHeart Whole Nutrition Infant Formula from their shelves following a nationwide recall. This urgent action comes in the wake of a botulism outbreak linked to the product that began on November 11, 2025. Despite the recall notice, the formula was left on store shelves for days or even weeks, raising serious concerns about the health risks posed to infants.
The FDA underscored the critical responsibility of retailers in such situations to act swiftly, especially when dealing with products that could potentially pose serious health risks to vulnerable populations like infants. With a hefty responsibility on their shoulders, retailers have been given 15 working days to respond and implement corrective actions to prevent further violations, with possible legal repercussions, including product seizures, if they fail to comply.
Details of the Recall and Outbreak
ByHeart Inc. has issued a voluntary recall of all batches of its Whole Nutrition Infant Formula after the FDA established a link to a multistate outbreak of infant botulism. As of December 10, 2025, a total of at least 51 infants across 19 states have been affected by this illness, which can lead to severe health complications and, in rare cases, can be fatal. Symptoms of infant botulism encompass constipation, poor feeding, drooping eyelids, and difficulty swallowing. The FDA strongly advises parents and caregivers to discontinue the use of the recalled formula immediately and consult healthcare providers if any symptoms arise.
Retailers’ Responses
In light of the FDA’s warning letters, Walmart expressed that it takes allegations of inaction very seriously, emphasizing their swift response to remove the contaminated product from impacted stores and online listings. Conversely, major retailers such as Target, Kroger, and Albertsons have yet to issue public comments regarding the FDA’s findings, leaving consumers concerned about the safety measures being taken across the board.
Understanding Infant Botulism
Infant botulism, while rare, is a serious illness that can arise from ingestion of Clostridium botulinum spores. These spores can produce toxins in an infant’s intestines, leading to muscle weakness, breathing difficulties, and in severe cases, respiratory failure. Given the potential dangers, early detection and timely medical intervention are critical for affected infants. The FDA is working closely with state and local health authorities to not only monitor the situation but to ensure that the safety of infant formula products remains uncompromised.
FDA’s Ongoing Efforts
The FDA’s commitment to resolving this issue is evident through its collaborative efforts with the Centers for Disease Control and Prevention (CDC) and state health departments. Their goal is to closely monitor the outbreak and maintain the safety standards of infant formula products available on the market. The FDA has called for greater adherence to best practices in recall implementations, especially concerning products intended for infants and young children. This kind of proactive regulation can encourage retailers and manufacturers to prioritize safety while fostering a competitive marketplace.
Recommendations for Parents and Caregivers
For concerned parents and caregivers, the FDA urges individuals to conduct thorough checks at home for any ByHeart Whole Nutrition Infant Formula products, including both canned and single-serve versions. Any discovered items should be discarded immediately to mitigate risk. Monitoring infants for signs of illness is vital, and prompt medical consultation is recommended if any symptoms develop. The FDA continues to provide guidance and updates to ensure the safety and well-being of infants across the nation.
Frequently Asked Questions (FAQ)
What is the FDA’s warning to retailers about?
The FDA has issued warning letters to major retailers, including Target, for failing to promptly remove ByHeart Whole Nutrition Infant Formula from their shelves after a nationwide recall due to a botulism outbreak.
What is the current status of the botulism outbreak?
As of December 10, 2025, at least 51 infants across 19 states have been affected by the botulism outbreak linked to ByHeart Whole Nutrition Infant Formula.
What should parents and caregivers do if they have ByHeart formula at home?
Parents and caregivers should immediately discontinue use of any ByHeart Whole Nutrition Infant Formula products and consult healthcare providers if infants exhibit any symptoms of illness.
What are the symptoms of infant botulism?
Symptoms of infant botulism include constipation, poor feeding, drooping eyelids, and difficulty swallowing. In severe cases, it can lead to respiratory failure.
How is the FDA addressing the situation?
The FDA is collaborating with the Centers for Disease Control and Prevention (CDC) and state health departments to monitor the outbreak and ensure the safety of infant formula products on the market.
Key Features of the Situation
| Feature | Details |
|---|---|
| FDA Warning Letters | Issued to major retailers, including Target, for failing to remove recalled ByHeart formula from shelves. |
| Botulism Outbreak | At least 51 infants across 19 states affected by botulism linked to ByHeart formula as of December 10, 2025. |
| Retailers’ Responses | Walmart stated it took all reports of inaction seriously and would respond to the FDA’s letter; other retailers have not publicly commented. |
| FDA’s Actions | Collaborating with CDC and state health departments to monitor the outbreak and ensure product safety. |
| Recommendations | Parents and caregivers advised to discontinue use of ByHeart formula and consult healthcare providers if infants exhibit symptoms. |
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