There is currently a major public-health alert regarding a multistate outbreak of infant botulism linked to powdered infant formula. The Centers for Disease Control and Prevention (CDC) and the United States Food and Drug Administration (FDA) are investigating what appears to be a cluster of cases among infants under one year old, with much of the focus narrowing on certain lots of formula made by ByHeart.
Infant botulism is rare but serious: it occurs when spores of the bacterium Clostridium botulinum are ingested by a baby, germinate in the immature gut, and produce a potent neurotoxin. Symptoms can include constipation, poor feeding or difficulty sucking, droopy facial features or weak muscle tone, and in severe cases respiratory difficulty. In this outbreak, as of early November 2025, at least 15 infants in 12 states have been reported hospitalized after consuming ByHeart formula products. Importantly, though no deaths have been reported at this time, the recall has been escalated dramatically.
Initially, on November 8 the company and regulators issued a voluntary recall of two specific lots of the product: lot numbers 206VABP/251261P2 and 206VABP/251131P2 (both with a “Use by 01 Dec 2026” date) of ByHeart Whole Nutrition Infant Formula. However, the recall was quickly expanded: by November 11 the company announced a nationwide recall of all its formula products (including cans and travel pouches) in close collaboration with the FDA, acknowledging that the potentially implicated product may be broader than the originally identified lots. The FDA emphasized that ByHeart accounts for less than 1 % of U.S. infant‐formula sales, and therefore the outbreak is not expected to trigger a nationwide formula shortage.
From a public health standpoint, this incident raises several critical issues:
While infant botulism is itself rare (typically fewer than 200 cases per year in the U.S.), the clustering of cases among infants who consumed the same brand of formula is concerning and suggests at least the possibility of a product‐related risk.
Although the FDA stated that no unopened cans of the product have definitively tested positive yet for the toxin or spores, the company and regulators are treating the situation with high caution and broad recall measures.
Parents and caregivers who used the recalled product are advised to immediately stop using it, discard or return it, and monitor their infants for symptoms of botulism (which may develop over weeks). They are also advised to clean any feeding equipment or surfaces that touched the formula.
For health care providers and parents, the key takeaway is vigilance: infants who consumed the recalled product and who show signs such as reduced feeding, droopy head or loss of head control, weak cry, or respiratory difficulty should receive immediate medical evaluation given the risk of rapid progression. The approved specific treatment for infant botulism is the antitoxin product BabyBIG.
In summary: This is a serious outbreak and recall, though early in the investigation. The link to the formula is not yet fully proven but is strong enough that sweeping action has been taken. If you are caring for an infant who used the formula in question (or whose caregiver is unsure), you should check the lot number, stop use if it matches, and stay alert for symptoms.
Author
Caring Pediatrics
Caring Pediatrics
