• ByHeart recalls all baby formula products nationwide following an outbreak of infant botulism.
• 15 infants across 12 states have been reported sick with symptoms of botulism.
• The recall includes all ByHeart formula sold in stores and online, although no unopened cans have tested positive.
• The FDA is conducting an investigation into the outbreak, while ByHeart is testing every batch of its products.
• The total reported cases of infant botulism linked to ByHeart formula amount to a significant proportion given the brand’s market share.

An outbreak of infant botulism linked to ByHeart baby formula has affected at least 15 infants in 12 states since mid-August, prompting the company to recall all of its products nationwide. Initially, only two batches were recalled, but as cases escalated, ByHeart expanded the recall to include all formula sold in homes and stores, including Whole Nutrition Infant Formula and Anywhere Pack pouches. As of now, no deaths have been reported, according to CBS News and SFGate.

The U.S. Food and Drug Administration (FDA) is actively investigating the outbreak and reported that about 36 of the 84 botulism cases detected since August involved infants who had consumed ByHeart formula. Although ByHeart represents less than 1% of all infant formula sales in the United States, the prevalence of the brand among sick infants raises significant concerns. ByHeart co-founders stressed their commitment to safety and transparency, stating that they are providing unrestricted access to their facilities for the investigation, as reported by CBS News and The Hill.

Infant botulism is a rare but serious illness that typically affects infants under the age of one, whose gut microbiomes are still developing. Symptoms can take weeks to manifest, often starting with constipation followed by a range of symptoms like poor feeding and muscle weakness. Treatment involves an IV medication called BabyBIG, which is the only treatment known to be effective against the toxin produced by the bacteria causing the illness. All affected infants in this outbreak have received treatment, according to CBS News and SFGate.

ByHeart clarified that while it has enacted this recall as a precautionary measure, no unopened cans of its formula have tested positive for contamination. The company has begun testing every batch of formula with an independent third-party laboratory to ensure safety. California health officials had previously confirmed contamination in a sample from an open can of formula consumed by an ill infant. The FDA continues to investigate the outbreak but has yet to link other brands of infant formula to the illness, according to SFGate and The Hill.