ByHeart Baby Formula Recall Linked to Botulism Outbreak

A significant outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula has led to the hospitalization of 31 infants across 15 states since August 2025. The U.S. Food and Drug Administration (FDA) confirmed that the formula was contaminated with Clostridium botulinum, a bacterium that can cause severe illness in infants. The affected states include Arizona, California, Idaho, Illinois, Kentucky, Maine, Michigan, Minnesota, North Carolina, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

NPR

ByHeart initiated a recall of all its infant formula products on November 11, 2025, after laboratory tests confirmed the presence of the bacteria in some samples. Despite the recall, reports indicate that the formula remains available on store shelves in several states, prompting further investigations by state and federal health officials. ByHeart, which produces approximately 200,000 cans of formula monthly, has stated it is cooperating with the FDA and conducting its own testing to identify the source of contamination.

PBS News Hour

Infant botulism can lead to paralysis and potentially fatal complications. Symptoms may take up to 30 days to manifest and include constipation, poor feeding, weak cry, drooping eyelids, and difficulty swallowing. Parents are advised to monitor their infants closely and seek immediate medical attention if symptoms arise. The California Department of Public Health has set up a hotline for parents to report concerns and seek guidance.

PBS News Hour

ByHeart has expressed its commitment to ensuring the safety of its products and has implemented measures to enhance testing protocols. The company has also established a 24/7 support hotline for affected families and is offering refunds for recalled products. In a statement, ByHeart co-founder Mia Funt emphasized the company's dedication to protecting infants and providing clear information to families.

FDA - Food and Drug Administration

The situation has drawn criticism from parents and health advocates, particularly regarding the company's initial response to the outbreak. Some parents have filed lawsuits against ByHeart, alleging negligence and seeking compensation for medical expenses and emotional distress. The lawsuits highlight concerns over the safety of the formula and the company's marketing practices.

NPR

While the FDA has confirmed 31 cases of infant botulism linked to ByHeart formula, there are discrepancies regarding the timeline and number of cases. The outbreak was initially reported with fewer cases, and the FDA continues to investigate the extent of contamination and the effectiveness of the recall.

NPR

The FDA and CDC are actively investigating the outbreak, working with state health departments to ensure that recalled products are removed from stores. Parents are urged to discontinue use of ByHeart formula and to keep any remaining products labeled as "DO NOT USE" for potential testing if symptoms develop in their infants. The situation remains fluid, with ongoing updates expected as investigations proceed.

FDA - Food and Drug Administration

“What to know about infant botulism Botulism is a rare but serious illness caused by Clostridium botulinum.” — U.S. Food and Drug Administration

NPR

“We immediately notified the F.D.A. of those findings, and we are working to investigate the facts, conduct ongoing testing to identify the source, and ensure this does not happen to families again.” — ByHeart

New York Times

“Please know that we are actively working on updates, and we will keep sharing information as quickly and clearly as we can.” — ByHeart

WJZ - CBS Baltimore

“Detection of Clostridium botulinum in infant formula is difficult, and a negative test result does not rule out the presence of the bacteria in the product," the FDA said, adding that results are expected in the coming weeks.” — U.S. Food and Drug Administration

WJZ - CBS Baltimore