What is infant botulism and how is it linked to ByHeart formula?

Infant botulism occurs when infants ingest botulism bacteria spores that germinate in their intestines, producing a toxin. Federal health officials suspect ByHeart formula produced since March 2022 may be contaminated with this bacteria, leading to an outbreak.

How many infants have been affected by the ByHeart formula outbreak?

As of the latest update, at least 51 infants in 19 states have been affected by the infant botulism outbreak linked to ByHeart formula.

What actions has ByHeart taken regarding the contamination?

ByHeart has recalled all its products sold in the U.S. and is cooperating with federal officials, including the FDA and CDC, to investigate the contamination and understand the full scope of related cases.

Home / Health / ByHeart Formula: Years of Contamination Feared

ByHeart Formula: Years of Contamination Feared

11 Dec, 2025

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Summary

All ByHeart formula ever produced may be contaminated.
Outbreak now includes 51 infants across 19 states.
Company faces lawsuits over alleged defects and negligence.

ByHeart Formula: Years of Contamination Feared

Federal health officials have issued a concerning update regarding an infant botulism outbreak, stating that all ByHeart baby formula produced since its inception in March 2022 may be contaminated. Investigations by the FDA and ByHeart are actively seeking the root cause of the contamination.

The expanded scope of the probe now encompasses at least 51 infants across 19 states, with the latest reported illness in December 2025. Cases have been reported nationwide, with California and Texas having the highest numbers. ByHeart, a small market share manufacturer, recalled all its products on November 11th.

This news has caused distress for parents who trusted the formula's "natural" and "gentle" reputation. Families have initiated lawsuits, alleging the formula was defective and that ByHeart acted negligently. Past inspection documents reveal previous contamination issues and a warning letter from the FDA in 2023.