A nationwide recall of powdered infant formula has been issued in the United States after U.S. federal and state health officials linked certain lots to a rare but potentially fatal illness known as infant botulism. 

This recall is significant because it directly affects caregivers of infants, one of the most vulnerable populations and highlights the importance of food safety, vigilance in infant nutrition, and immediate response if symptoms arise. 

In this explainer, you will learn exactly what is going on, how this situation developed, what the risks are, and what you can do if your baby may have been affected.

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Definition & Background

What is happening?

On November 8, 2025, the U.S. Food and Drug Administration (FDA) announced that the formula manufacturer ByHeart Inc. is voluntarily recalling two specific lots of its “Whole Nutrition Infant Formula.”  These lots are labeled:

• Lot 206VABP/251261P2 (“Use by 01 Dec 2026”)
• Lot 206VABP/251131P2 (“Use by 01 Dec 2026”)

What is infant botulism?

Infant botulism is a form of botulism (caused by the bacterium Clostridium botulinum) that occurs when spores are ingested or inhaled by an infant, colonize in the large intestine, and produce neurotoxins that impact muscle tone and nerve function.  It is rare, but when it does occur, it can be severe and even life-threatening.

Why is this relevant now?

According to the Centers for Disease Control and Prevention (CDC) and FDA, at least 13 confirmed infant botulism cases across 10 U.S. states have been linked to consumption of the recalled formula.  The recall is being done “out of an abundance of caution” because while a direct causal link has not yet been definitively established, there is enough concern to prompt immediate action.

How the Recall Came About & What Happened

• Investigation timeline & key facts
• Since August 2025, health authorities have recorded an increase in reports of infant botulism in babies who consumed formula.
• The two lots of ByHeart formula at issue were distributed nationwide, via online and major retail channels (including Amazon, Target, Whole Foods, etc.).
• Preliminary tests by California health officials found the presence of bacteria consistent with the type that can produce botulinum toxin in one sample of the formula under investigation.
• The formula brand in question accounts for less than 1 % of all infant formula sales in the U.S., according to the FDA.

How could contamination happen?

While the exact contamination route is still under investigation, powdered infant formula is not sterile and may carry risk if spores are present and environmental conditions allow growth of C. botulinum. Preparation, storage conditions, and handling can all contribute to risk.

What is being recalled and what to do?

Parents and caregivers who have purchased formula should:

• Check if the formula is one of the impacted lots (206VABP/251261P2 or 206VABP/251131P2, “Use by 01 Dec 2026”).
• Immediately stop using and discard those cans, or return them for replacement per the manufacturer instructions.
• Wash, sanitize bottles, utensils, and surfaces that may have contacted the formula using hot, soapy water or a dishwasher.

Closely monitor any infant who consumed the product for symptoms (see next section) and seek medical attention promptly if concerns arise.

Impact & Risks

What are the symptoms and risks for infants?
Typical early symptoms of infant botulism include:

• Constipation (often the first sign)
• Difficulty feeding or sucking
• Weak cry or altered cry
• Loss of head control or reduced muscle tone
• Weak facial expression or drooping eyelids
• Difficulty swallowing, breathing, or respiratory weakness

If untreated, the neurotoxin can cause progressive paralysis, including respiratory failure, which is why the illness is considered “potentially fatal.”

What is the scale of the outbreak? As of the most recent reports:

• 13 confirmed infants hospitalized across 10 states.
• No deaths have been reported so far.

The recall currently involves one brand and two lots, but investigation is ongoing to determine whether other lots, products, or brands could be affected.

What about the broader formula supply?

Given that the impacted brand represents less than 1 % of formula sales, the FDA indicates there is no current national shortage concern due to this recall.

Analysis & Insight

1. Expert perspective
Food safety experts emphasize that while powdered infant formula is not sterile (unlike many liquid formulas), it must be handled with extra care. The presence of C. botulinum spores is rare but serious when present.  Dr. Devon Kuehn (CMO of ByHeart) has noted that global health recommendations do not currently mandate routine testing of powdered infant formula for C. botulinum spores, which may expose a gap in standard safety testing protocols.

2. Wider context and lessons
This recall underscores several key points for American caregivers and for the food/product-safety system:

3. Even products considered well regulated can face unexpected contamination risks.

4. Vigilance and rapid response (by both regulators and manufacturers) are critical to protect infants.

5. The fact that the manufacturer acted voluntarily “out of an abundance of caution” shows the role of proactive safety culture.

The event may lead to deeper scrutiny of how infant formula (especially powdered forms) are tested and manufactured.

What this means for U.S. parents & caregivers, for parents, this means:

• If you used the recalled lots, pause further use and monitor your baby carefully.
• Understand that infants are uniquely vulnerable to certain micro-organisms due to their immature digestive and immune systems.
• Maintain high standards of hygiene during formula preparation (wash hands, use clean bottles, adhere to manufacturer instructions).

If you see worrying symptoms poor feeding, muscle weakness, difficulty swallowing or breathing, seek medical help immediately and inform the provider about the formula brand and lot if relevant.

Final thought

If you are caring for an infant and relied on formula, this is a moment to review the brand and lot number, be attentive to your baby’s feeding and behavior, and ensure you remain confident in the sources of their nutrition. 

The health of infants depends on both safe products and informed caregiving. You might also consider discussing with your pediatric provider whether alternative formulas are suitable and what additional precautionary steps you should take at home.