ByHeart Whole Nutrition Infant Formula is the product involved in the recall. Fifteen infants have been hospitalized in 12 states prompting a federal investigation. Clinicians are urged to treat on suspicion and report all cases.
The FDA has expanded its recommendation to include all ByHeart infant formula products as part of a national recall due to the number of ill infants reported to have consumed this product, the identification of additional lot codes, the identification of new cases of suspected infant botulism, and the preliminary positive sample collected and tested.1
The FDA, Centers for Disease Control and Prevention (CDC), and California Department of Public Health are investigating this multistate outbreak of infant botulism linked to the infant formula. As of November 10, 15 infants in 12 states including AZ, CA, IL, KY, MN, NC, NJ, OR, PA, RI, TX, WA have suspected or confirmed illness, all hospitalized, but no deaths have been reported.1
Laboratory analysis from California identified Clostridium botulinum in an open can of ByHeart formula (lot 206VABP/251131P2) consumed by an affected infant. The bacteria produce botulinum toxin, which can cause flaccid paralysis and respiratory failure in infants. While confirmatory testing continues, the FDA has expanded its advisory to all unexpired ByHeart cans and single-serve “anywhere” sticks.1
Between August and November 2025, the Infant Botulism Treatment and Prevention Program (IBTPP) reported treating 84 infants nationwide for botulism, 36 infants had powdered formula exposure, and 15 had consumed ByHeart products, disproportionate representation given ByHeart’s ≈1% share of the US formula market. No other formula brands or exposures have been implicated.1
Parents/caregivers should immediately discontinue all ByHeart formula use and monitor infants for early neurologic or feeding changes.
Clinicians suspecting infant botulism should contact the IBTPP (510-231-7600) for 24/7 case consultation and antitoxin coordination.
Public health officials are collecting residual formula for confirmatory testing and advising families to retain product containers marked “DO NOT USE” for potential analysis.
The FDA emphasized that ByHeart accounts for a small fraction of the national supply and that no formula shortage is expected. The investigation remains ongoing to determine the contamination source, with updates to follow as laboratory data are finalized.
Infant botulism occurs when ingested Clostridium botulinum spores colonize the intestine and produce neurotoxin that blocks acetylcholine release at neuromuscular junctions, causing symmetric, descending flaccid paralysis; clinical features, often beginning several weeks after exposure, include constipation, poor feeding, weak/altered cry, ptosis, loss of head control, diminished suck/gag, dysphagia, progressive hypotonia, and respiratory difficulty that can progress to respiratory arrest.2
Definitive diagnosis requires stool or enema specimens analyzed through state public-health laboratories, though results can take several days. Treatment should never be delayed pending confirmation. Once BabyBIG is administered, IBTPP and state health authorities coordinate follow-up reporting through the National Notifiable Diseases Surveillance System.2
The CDC emphasizes that infant botulism is a clinical diagnosis that must be treated immediately upon suspicion without waiting for laboratory confirmation. Physicians should contact the IBTPP at 510-231-7600, available 24/7, for free consultation and to obtain BabyBIG human antitoxin. Infant botulism is a notifiable disease, and all suspected cases must be reported to state health departments.2
While case numbers remain limited and no deaths have been reported, the outbreak underscores the severity of infant botulism and the importance of rapid recognition and treatment. Ongoing collaboration among FDA, CDC, and state health authorities aims to trace the contamination source, but in the interim, clinical vigilance and timely intervention remain the most effective tools to prevent serious outcomes.
