When Formula Turns Toxic: Infant Clostridial Infection, ByHeart® Recall, and What Parents Need to Know

Article 8 in the Got REAL Milk Series

The Newest Formula Scare: Clostridium in the Nursery

The FDA and CDC recently announced an investigation into infant botulism potentially linked to powdered infant formula manufactured by ByHeart® Inc. Two lots of its “Whole Nutrition Infant Formula” were voluntarily recalled after testing found possible contamination with Clostridium botulinum spores.

Although no definitive link has yet been confirmed between the formula and all reported cases, the very presence or even suspicion of C. botulinum in infant formula is alarming. Infant botulism is rare but potentially fatal, causing flaccid paralysis, weak cry, and feeding difficulty.

Formula Contamination: Not an Isolated Incident

This recall joins a growing list of microbial contamination events in US formula production from Cronobacter sakazakii at Abbott’s Sturgis plant to Salmonella outbreaks in powdered formula overseas. Each case demonstrates the fragility of industrialized infant nutrition systems, where powdered milk ingredients, processing, and supply chains can introduce pathogenic risk.

ByHeart’s branding as a “clean, carefully sourced, small-batch” formula reveals an uncomfortable truth: contamination can occur at any scale when ingredients, equipment, or water sources harbor spores resistant to standard sterilization.

The Microbiome Connection: Why Infants Are So Vulnerable

Newborns’ guts are meant to be colonized gradually by beneficial microbes through breastfeeding, skin contact, and environmental exposure. Formula feeding alters this microbial succession, often resulting in higher colonization by Clostridia, Enterobacteriaceae, and other opportunistic bacteria.

When pathogenic species like C. botulinum or C. difficile find this vulnerable terrain especially in infants under six months, the immature microbiome lacks the protective flora to suppress their growth.

Glyphosate’s Hidden Role: Fuel for Clostridial Overgrowth

Here’s where environmental toxicology enters the nursery.In 2013, Shehata et al. (Current Microbiology, 2013) demonstrated that glyphosate, the world’s most widely used herbicide, selectively suppresses beneficial gut bacteria (e.g., Lactobacillus, Bifidobacterium) while allowing Clostridium and Salmonella to flourish.

This finding has since been replicated and expanded: glyphosate’s interference with the shikimate pathway impairs bacterial metabolism and alters the gut ecosystem in favor of toxin-producing anaerobes. While the study did not specifically measure C. botulinum, it did show increased growth potential of clostridial species as a group.

Given the widespread presence of glyphosate residues in cow’s milk and soy-based formulas, this creates a plausible synergy; chemical exposure weakening microbial balance, creating the path for clostridial colonization.

A Pattern Emerging

From my vantage point as a pediatrician, these incidents point to a pattern, not a coincidence:

• Industrial food systems expose infants to microbial and chemical hazards simultaneously.
• Regulatory oversight remains reactive rather than preventive.
• Infant gut ecology is increasingly disrupted from cesarean birth, antibiotic and other pharmacologic exposures, and formula feeding to chemical residues in milk powders.

What Parents Can Do

• Check the recall. If you have ByHeart® formula, stop use immediately and consult the FDA recall notice.
• Watch for symptoms of infant botulism: weak cry, poor feeding, constipation, hypotonia, or lethargy.
• Prioritize clean feeding options. When possible, breastfeed. For formula-fed infants, choose certified organic, low-residue brands and prepare with filtered water.
• Support the microbiome. Encourage natural gut resilience with maternal probiotic use during lactation, organic nutrition, and avoidance of unnecessary antibiotics and pharmacologics.

Bigger Questions Ahead

If glyphosate can alter microbial balance in ways that empower pathogens, and formula can carry spores or residues, what does that mean for our youngest citizens’ immune foundations?This is precisely the conversation we aim to foster at GMOScience: connecting environmental exposure, microbial disruption, and children’s health.

References

1. Shehata A A et al. The Effect of Glyphosate on Microorganisms of Different Ecological Niches. Curr Microbiol.2013;66:350–358.
2. ByHeart Initiates Voluntary Recall of Two Batches of Infant Formula. November 2025.
3. Infant Botulism Information for Clinicians.
4. Marler B. FDA Dashboard: ByHeart—You Have Some Issues. Marler Blog, 2025.