Multistate Infant Botulism Outbreak Tied to Recalled ByHeart Formula

Federal and state health officials are investigating a multistate outbreak of infant botulism that public health authorities have linked to ByHeart Whole Nutrition powdered infant formula. The Centers for Disease Control and Prevention reported on November 21 that 31 cases have been identified across 15 states, including eight newly reported cases since the previous update. All 31 affected infants were hospitalized and there have been no deaths reported to date. The investigation remains ongoing.

ByHeart issued a recall on November 11, covering all lot numbers and sizes of its Whole Nutrition infant formula. Parents and caregivers are being urged to stop using any recalled ByHeart formula immediately. Health officials say infants who consumed the product should be watched closely for signs of infant botulism, which can include poor feeding, loss of head control and difficulty swallowing. Families are advised to seek medical evaluation if those symptoms appear.

The CDC has provided clinicians with guidance on diagnosis and recommended treatment for infant botulism. The recommended specific therapy is human-derived botulism immune globulin, known as BabyBIG. Clinicians are encouraged to consider the diagnosis in infants with compatible symptoms and to contact public health authorities for case reporting and access to treatment resources as needed. Public health hotlines and coordination through state health departments are part of the ongoing response.

Investigators are asking caregivers to retain any leftover product and to record lot information to assist traceback efforts. Public health teams are working to identify the scope of distribution, to determine whether contamination was limited to particular production runs or more widespread, and to identify potential points of contamination. The recall of all lot numbers and sizes signals a wide precautionary measure while those investigations proceed.

Infant botulism is a rare but serious illness caused when Clostridium botulinum spores grow in an infant's intestine and produce toxin. The disease typically requires careful supportive care and, when indicated, the antitoxin that can neutralize circulating toxin. Prompt recognition and treatment are critical to reduce complications and the length of hospitalization.

The outbreak has intensified scrutiny of powdered infant formula safety and raised alarm among parents already concerned about infant nutrition and supply. Public health officials continue to emphasize that not all powdered formulas are implicated, and that caregivers should check product labels and lot numbers against the recall notice. Health agencies are also coordinating with laboratory and regulatory partners to complete testing, identify the source of contamination, and inform distribution recalls and guidance to clinicians and families.

As the investigation proceeds, authorities say they will update case counts, geographic distribution and public guidance. For now, the central message from health officials is clear, stop use of recalled ByHeart formula, preserve any leftover product and seek medical care if infants who consumed it develop feeding or swallowing difficulties.