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Two Firms Linked to Botulism Contamination in ByHeart Baby Formula

2026-01-28
in National
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Risky Business: Dried Milk Powder Tied to ByHeart Formula Botulism Outbreak

The ongoing investigation into a botulism outbreak linked to ByHeart infant formula has identified dried milk powder from two suppliers that may be at fault. This alarming development comes as health authorities report that 51 infants across 19 states have been affected, raising serious concerns about food safety for the nation’s littlest consumers.

Why It Matters

This incident highlights significant public health risks associated with infant formula safety. With botulism spores posing particular dangers to infants, the situation underlines the need for stringent safety measures and regulations in food production and processing, especially concerning products consumed by babies whose bodies are still maturing.

Key Developments

  • Dried milk powder linked to the outbreak was sourced from Organic West Milk Inc. and processed at a Dairy Farmers of America plant.
  • Tests revealed the presence of botulism bacteria in a sample of the organic whole milk powder collected by the FDA.
  • Both companies and the FDA affirmed that the source of the contamination has not yet been definitively identified.
  • Organic West Milk has ceased sales of its powder intended for infants and children.
  • ByHeart has issued a recall of all its products following the findings.

Full Report

Investigation Ongoing

The investigation into the botulism outbreak continues, as both Organic West Milk and the Dairy Farmers of America cooperate with the FDA. Bill Van Ryn, a co-owner of Organic West Milk Inc., confirmed that a company sample tested positive for the botulism-causing bacteria. However, he stressed that this does not necessarily indicate that their product is the outbreak’s source. “Nothing has been proven about our milk yet,” he clarified, noting the complexities during the processing stages.

Processing Procedures

In dairy processing, powdered milk is created using a detailed method that involves pasteurization, evaporation, and spray-drying. The Dairy Farmers of America plant processes approximately 1.5 million pounds of raw milk daily into various products, including milk powder that complies with established safety tests. Following the FDA’s findings, the cooperative underscored that the tested powder had passed regulatory requirements before being sold to ByHeart.

Health Risks for Infants

Experts explain that while Clostridium botulinum spores may be common in various foods, they pose a heightened risk for infants due to their still-developing digestive systems. These spores can produce a toxin that leads to paralysis and potentially fatal outcomes if they grow unchecked in young children. The FDA’s recent investigations also indicated that live botulism bacteria were found in unopened cans of ByHeart formula, matching both sick infants and milk powder samples tested during the investigation.

Response from ByHeart

In light of the incident, ByHeart has taken the precautionary step of recalling all products. However, company representatives have opted not to publicly identify the sources of specific milk powder samples tied to the investigation.

Context & Previous Events

Although botulism spores have been detected in infant formula before, this outbreak represents the first significant incident of its kind linked to a commercial product. Previously, mandatory testing for botulism in infant formulas was not required as the risk was considered low, leaving some manufacturers to conduct voluntary screenings.

As this situation progresses, health officials and consumers alike will be closely monitoring updates from both the FDA and the involved companies.

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