ByHeart infant formula
FDA

The manufacturer ByHeart issued a voluntary recall of all its powdered infant formula products earlier this November, following a multistate outbreak of infant botulism linked to the brand's Whole Nutrition Infant Formula.

However, several families say their babies fell ill months earlier, between late 2024 and mid-2025, after being fed the same product. This has raised concerns about whether early warning signs were overlooked.

According to the United States Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), at least 31 infants across 15 states are suspected or confirmed to have developed botulism after consuming ByHeart formula during the period from 9 August to 13 November.

Symptoms of infant botulism to watch for in babies who may have consumed the affected product include poor feeding, loss of head control, difficulty swallowing and decreased facial expression.

Early Cases Spark Questions Over Outbreak Timing

In California, the state health department confirmed that six babies who consumed ByHeart formula between November 2024 and June 2025 were hospitalised with infant botulism or suspected cases. A parent, in a conversation with the Associated Press, said they did not believe it was a coincidence.

Despite these earlier illnesses, health officials say they could not establish a clear connection to the outbreak due to missing lot numbers and insufficient product samples. Dr Jennifer Cope of the CDC clarified that this does not necessarily mean the cases were unrelated.

Expanded Recall After Bacteria Detected in Formula

The investigation revealed that unopened cans of ByHeart formula have tested positive for Clostridium botulinum.

On 8 November, California officials announced the confirmation of type A botulinum bacteria in an opened can linked to a recent case. ByHeart subsequently informed the FDA that tests conducted by independent laboratories on unopened cans also detected the bacterium. This prompted an expanded recall covering all lots, regardless of whether a specific illness had been reported.

The FDA noted that while ByHeart accounts for roughly 1 percent of US formula sales, it has been associated with a disproportionately high number of the cases under investigation.

Why Initial Cases Failed to Trigger Investigation

For affected families, the situation has prompted frustration and confusion. As one mother asked: 'Why did the cases beginning in August flag an investigation, but the cases that began in March did not?'

The delay in linking the early cases to the broader outbreak appears to stem from several factors. Infant botulism is extremely rare, which complicates monitoring and trend detection. Symptoms can take weeks to appear and may initially resemble other conditions.

Health authorities also stressed that many of the early cases lacked product lot details or retained formula containers, both of which are essential for laboratory testing and tracing the source. As a result, early clusters did not have enough statistical support to trigger a formal investigation until cases surged dramatically after August.

Parents Urged to Stay Vigilant Amid Recall

Ongoing enquiries by the FDA and CDC now focus on determining how contamination occurred, identifying any manufacturing or distribution issues and understanding why earlier illnesses were not flagged sooner.

Parents are urged to remain vigilant and monitor babies closely for any symptoms, while staying informed about recall alerts.

The incident underscores the need for stringent quality-control measures, robust supply-chain tracking and rapid regulatory action, particularly for high-risk products such as infant formula.

While botulism linked to powdered formula is rare, this outbreak highlights how contamination in even small-market brands can lead to widespread risk.

Authorities anticipate that the situation will lead to heightened scrutiny of formula manufacturing practices and environmental safety standards across the industry.

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