ByHeart Baby Formula Recall Tied to Botulism Outbreak Affecting 13 Infants

Mon Nov 10 2025 01:37:00 GMT+0200 (Eastern European Standard Time)

California health officials have issued a recall of ByHeart Whole Nutrition Infant Formula following the detection of botulism-causing bacteria. The outbreak has affected 13 infants across ten states, urging immediate action from consumers.

Recent tests have identified the presence of bacteria linked to a botulism outbreak in ByHeart baby formula, prompting health officials in California to recall specific lots of the product. At least thirteen infants in ten states have fallen ill after consuming the formula, which was found to potentially contain the harmful toxin. The situation is under investigation, with health authorities advising consumers to cease use of the product immediately.

California health officials reported that preliminary tests revealed that ByHeart baby formula contained bacteria that produces the toxin linked to a botulism outbreak. This outbreak has affected at least 13 infants across 10 states, leading to hospitalizations, but fortunately, no deaths have been reported.

In response to the troubling findings, the California Department of Public Health advised, Consumers in possession of this product should stop using it immediately. Ongoing investigations are being conducted by both state and federal health officials, who are examining more samples of ByHeart Whole Nutrition Infant Formula. The New York-based company has already recalled two lots of the product, identified with a best-by date of December 2026.

Infant Botulism Details

The affected infants, aged between 2 weeks to 5 months, became ill after consuming ByHeart's powdered formula. As per the U.S. Centers for Disease Control and Prevention (CDC), affected states include Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington.

While further testing is underway to confirm findings, ByHeart officials confirmed that they take these matters seriously and are cooperating with investigations by health authorities. Current reports indicate 83 cases of infant botulism since mid-August, which adds urgency to the recall and the investigation.

Understanding Infant Botulism

Infant botulism is a rare condition that affects fewer than 200 babies in the U.S. each year. It results from a type of bacteria that produces toxins in babies' intestines, potentially leading to serious ailments such as paralysis. Infants under one year old are especially vulnerable, often contracting the bacteria from environmental spores or contaminated honey.

Symptoms include poor feeding, loss of head control, and other serious issues requiring hospitalization and, in some cases, ventilation support. All infants linked to this outbreak have reportedly received treatment with BabyBIG, the standard IV medication for botulism in infants.

Broader Implications

Despite the ongoing concerns, health experts indicate that no infant formula shortages are expected from this incident, as ByHeart represents only 1% of the market share. However, this event sheds light on potential systemic issues in the infant formula industry, prompting reviews on ingredient safety for products that millions of American babies rely on.