Nationwide Baby Formula Recall Linked to Infant Botulism: What Every Parent Should Know

A major recall has been issued for all products of ByHeart’s “Whole Nutrition” infant formula after a multistate outbreak of Infant botulism, a rare but serious illness, was linked to the product.

For families who use or have used powdered formula, this is a deeply unsettling development. 

At Morgan & Morgan, we know that when infants are harmed due to products they depend on, parents have questions about how the illness can occur, who is responsible, and when legal help may be needed. And as parents, you deserve answers—and justice.

If your family was affected or harmed by these recalled formulas, contact Morgan & Morgan today for a free case evaluation to learn more about your legal options.

What Happened With ByHeart’s Whole Nutrition Infant Formula?

The FDA and Centers for Disease Control and Prevention (CDC) are investigating an outbreak of infant botulism among babies who consumed the ByHeart formula. As of early November 2025, 15 infants in 12 states have been hospitalized.

On November 8, 2025, ByHeart voluntarily recalled two specific lots of its Whole Nutrition Infant Formula after engaging with regulators. By November 11, it expanded the recall to all its formula products nationwide, including all lot numbers, cans, and single-serve packets.

Regulators say that the brand’s product accounts for roughly 1% of the U.S. infant formula market, yet it appears disproportionately represented among the affected infants.

 

What Is Infant Botulism, and How Does It Relate to Formula?

Infant botulism is a rare condition that occurs when an infant (typically under one year old) ingests spores of the bacterium Clostridium botulinum, which then germinate in the immature gut, produce neurotoxins, and cause nerve- and muscle-related illness.

Typical early symptoms include:

• Constipation
• Poor feeding or weak sucking
• Drooping facial expression, weak cry
• Loss of head control or low muscle tone
• Difficulty swallowing or breathing in more severe cases

In this outbreak, although the FDA and CDC have not yet confirmed a direct causal link between an unopened formula can and infant illness, epidemiological data strongly suggest the ByHeart formula was consumed by all the affected infants.

 

What Should Parents Do?

If you have used ByHeart formula (or have it on hand), consider the following steps:

1. Stop using the product immediately. The recall covers all lot numbers of ByHeart’s Whole Nutrition Infant Formula.
2. If you still have product in your home, record the lot number and use-by date (if visible) and dispose of or return it according to the manufacturer’s instructions.
3. Clean and sanitize any feeding equipment, surfaces, or containers that may have contacted the formula using hot soapy water or a dishwasher.
4. Monitor your infant for the symptoms listed above, especially if they consumed the recalled formula. Symptoms may take several weeks to appear.
5. If your infant shows any symptoms, such as poor feeding, a weak cry, loss of muscle tone, difficulty swallowing or breathing, seek immediate medical attention. 
   
    

How Morgan & Morgan Can Help

When infants become seriously ill after consuming a trusted nutritional product, certain legal concerns may arise.

Was the product defectively designed or manufactured? Did the manufacturer (or distributor) fail to warn consumers about the risk? Could the product carry liability for hospitals, medical bills, long-term care, or disability related to the illness?

Even though infant botulism is rare, its effects can be overwhelming, potentially leading to significant medical costs, emotional trauma, and long-term consequences, depending on the severity of the nerve damage.

At Morgan & Morgan, we help families evaluate whether a manufacturer’s recall or regulatory action indicates potential grounds for legal recourse. If your infant was ill after ingesting a recalled product, we can assist in exploring how to protect your child’s rights and ensure responsible parties are held accountable where appropriate.

If your baby was fed ByHeart Whole Nutrition Infant Formula, and in particular if your baby has experienced any symptoms of infant botulism, please reach out to us for a free case evaluation. We can review your case, help you understand the responsible parties, and advise you on next steps. The earlier action is taken, the better we can protect your child’s interests.