A scoop of formula milk powder
A scoop of formula milk powder Towfiqu barbhuiya/Pexels

The US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have launched a nationwide investigation after a rare outbreak of infant botulism was linked to ByHeart Whole Nutrition Infant Formula. Thirteen babies across ten US states have been hospitalised, prompting the company to issue an immediate voluntary recall of two batches of its powdered baby formula.

Health authorities confirmed that the investigation began after a series of hospital admissions between August and November 2025 showed identical symptoms of botulism, a potentially fatal bacterial illness. While no deaths have been reported, the FDA has described the recall as a critical precautionary measure as laboratory testing continues.

FDA Investigation Traces Possible Contamination

According to an official report from CDC, the recall was initiated after the FDA detected the possible presence of Clostridium botulinum spores, the bacteria responsible for infant botulism, in production environments connected to ByHeart products.

The agency said there is currently no confirmation that the toxin itself was present in the recalled formula but warned that even trace contamination could be dangerous for infants under one year old.

The CDC confirmed that cases have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. The illnesses reportedly began between mid-August and early November. Investigators are still working to determine how and where the contamination occurred within the supply chain.

Two Product Lots Recalled Nationwide

ByHeart has recalled two specific production lots of its Whole Nutrition Infant Formula: Lot 206VABP/251261P2 and Lot 206VABP/251131P2, both marked with a 'Use by 01 Dec 2026' label. The products were distributed through national retailers and online platforms and represent less than one per cent of the total US formula market.

Parents are urged to stop using the formula immediately and record the lot number if possible. The FDA further advises that bottles, scoops, and surfaces that came into contact with the product should be cleaned thoroughly using hot soapy water or a dishwasher sanitisation cycle.

ByHeart said in its official statement that the recall was issued 'out of an abundance of caution'. The company added that all internal testing to date had shown no detection of C. botulinum but that it fully supports the FDA's decision to withdraw the affected batches while the investigation continues.

What Is Infant Botulism and Its Symptoms

Infant botulism occurs when spores of Clostridium botulinum grow inside the intestines and produce toxins that interfere with muscle function. Because infants' digestive systems are not yet fully developed, they are more susceptible to infection.

Symptoms can include constipation, weak muscle tone, drooping eyelids, feeding difficulties, and breathing problems.

Health experts stress that any infant showing these signs should receive immediate medical attention. All thirteen affected babies are currently receiving hospital treatment, and all are reported to be in stable condition.

ByHeart and Federal Response

ByHeart has pledged full cooperation with the FDA and CDC. The company is conducting an internal review of its manufacturing and quality control processes to identify any potential source of contamination.

Federal officials are now inspecting ByHeart's production facilities and tracing raw material supplies. The CDC noted that this is the first known case in which infant formula has been linked to a suspected botulism outbreak in the United States.

The recall comes at a time when the FDA is undertaking its first major review of infant formula safety regulations in three decades, following public concern over previous shortages and production lapses in 2022. The ByHeart case is expected to prompt closer scrutiny of smaller formula manufacturers and their safety practices.

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