On November 11, 2025, the U.S. Food and Drug Administration (FDA) announced a nationwide recall of all ByHeart Whole Nutrition Infant Formula products after several cases of infant botulism were reported across multiple states. At least 15 infants became ill after consuming the company’s powdered formula, prompting the FDA and the Centers for Disease Control and Prevention (CDC) to launch a full investigation.
ByHeart maintains that no unopened cans have tested positive for the bacteria that produce botulinum toxin, but the investigation is still ongoing. The recall includes all sizes and lot numbers of its powdered formula and single-serve “Anywhere Pack” products.
What is Infant Botulism?
While rare, infant botulism is a serious illness. Affecting babies under one year old, it is caused by a bacterium called Clostridium botulinum, which produces the same neurotoxin found in Botox.
Unlike illness caused by foodborne botulism, which results from eating improperly canned or spoiled food that already contains the toxin, infant botulism occurs when a baby swallows spores of the bacteria. These spores are harmless to most people, but in babies, whose digestive systems are still developing, the spores can begin to grow and produce toxin inside the intestines.
Because the toxin gradually builds within the baby’s body, infant botulism usually progresses more slowly than foodborne botulism in adults. An adult who eats contaminated food can get sick within hours, but a baby may take several days before symptoms appear as the bacteria multiply and release toxin.
The toxin blocks the nerve signals that control muscles, causing weakness and, in severe cases, paralysis. The following symptoms might alert parents of the condition:
- Constipation
- Floppy limbs and/or loss of head control
- Trouble feeding or swallowing
- Tiredness or weakness
- In serious cases, difficulty breathing
The symptoms are serious; luckily, however, most babies recover completely with medical care. After a doctor neutralizes the toxin, babies are often hospitalized for monitoring and support with feeding or breathing.
Why Adults Don’t Get Infant Botulism
Adults and older children almost never suffer from this form of illness due to the difference in their digestive systems. As people grow, their digestive system matures and is colonized with protective bacteria. These healthy bacteria, combined with stronger stomach acid, prevent botulism spores from growing and producing the toxin.
Babies under 12 months old don’t yet have this protection, making them uniquely vulnerable to these bacterial spores and the resulting illness.
Why Powdered Formula Can Be a Risk
A key aspect of this recall is the fact that powdered infant formula is not sterile. Even under ideal manufacturing conditions, some bacteria and spores can survive the drying process. Liquid “ready-to-feed” formulas are heat-sterilized during packaging and carry a much lower risk of bacterial contamination but are not fully risk-free. Proper handling and preparation of all infant formula is essential, as is keeping up to date with any product recalls.
What Parents Can Do to Protect Their Babies from Infant Botulism
While infant botulism is rare, there are a few simple, effective steps parents can take to reduce the risk during their baby’s first year of life. Eliminating exposure entirely to Clostridium botulinum would be impossible, as the spores are common in the environment; however, the following steps can help avoid exposure.
Avoid Honey Until After Age One
Honey is a well-known natural source of Clostridium botulinum spores. Even a tiny amount of honey can harbor the botulism spores.
Handle and Prepare Infant Formula Safely
Most powdered formulas are not sterile. That means they can sometimes contain small numbers of bacteria or spores. To lower the risk:
- Wash bottles, nipples, and preparation surfaces thoroughly after every feeding.
- Feed immediately after preparation. Don’t leave mixed formula at room temperature for extended periods before feeding.
- Using ready-to-feed liquid formulas is the safest option because they are sterilized during manufacturing.
Watch for and Respond to Recalls
Product recalls can happen even in trusted brands. The recent ByHeart infant formula recall shows how quickly a contamination issue can emerge and how important it is for parents to stay informed. To stay safe,
- Check lot numbers before feeding your baby and stop using any recalled formula immediately.
- If you suspect your baby became ill after consuming a specific product, contact your pediatrician and report the case to the FDA’s MedWatch program.
- Remember: botulism is treatable, especially when recognized early. Trust your instincts if you sense your child is experiencing unusual symptoms. Prompt medical care has excellent recovery outcomes.
Keep Your Baby’s Environment Clean
Spores can also be found in soil, dust, or on unwashed produce. Babies often put their hands and toys in their mouths, so:
- Wash fruits and vegetables thoroughly before preparing baby food.
- Keep floors, carpets, and play areas clean and dust-free.
- Always wash your hands before feeding or handling your baby’s food.
TL;DR
While infant botulism is rare, it can be life-threatening if untreated. The ByHeart recall serves as a critical reminder that “natural” or “premium” brands aren’t always risk-free. Even small lapses in manufacturing or preparation can have serious consequences for infants.
Parents can minimize the risk by choosing sterile, ready-to-feed formulas when possible, following safe preparation guidelines, and avoiding honey or other potential spore sources during the first year of life.
How Schlesinger Law Offices Can Help
For more than 70 years, Schlesinger Law Offices has helped families across the United States hold major corporations accountable when defective or contaminated products cause serious harm. Our team understands both the medical and emotional toll these cases take on parents, and we work tirelessly to uncover what went wrong and who is responsible.
If your child became ill after consuming infant formula, our attorneys will review your potential claim at no cost. We work on a contingency basis, meaning you pay nothing unless we win. Schlesinger Law Offices is committed to seeking justice and fair compensation for every family we represent.
Call (954) 467-8800 or visit our contact page to start your no-risk case review.