If you’re a parent or caregiver using ByHeart Whole Nutrition infant formula, you’re advised to cease use immediately. All lot numbers, including all sizes of cans and single serve packets, have been recalled due to an infant botulism outbreak.
ByHeart Whole Nutrition Infant Formula Recall Issued After Link to Infant Botulism
The Centers for Disease Control and Prevention (CDC), the California Department of Public Health Infant Botulism Treatment and Prevention Program, the U.S. Food and Drug Administration (FDA), and public health officials in several other states are currently investigating a multi-state outbreak of infant botulism that’s been linked to the ByHeart Whole Nutrition brand of formula.
As of publication, there have been over 30 hospitalizations across 15 states, including:
- Texas
- Arizona
- California
- Minnesota
- New Jersey
- Illinois
- Kentucky
- Rhode Island
- Oregon
- Pennsylvania
- Washington
- Maine
- Idaho
- North Carolina
- Michigan
The recall applies to all ByHeart Whole Nutrition infant formula lot numbers, including all size cans and single serve packets. These products, which began clinical trials in 2019, were available online and at popular grocery chains throughout the U.S, including Target, Walmart, Safeway, Sprouts Organic Market, Kroger, Jewel-Osco and Star Market. As of November 20, 2025, the FDA received reports indicating that ByHeart Whole Nutrition infant formula was still available for sale at these locations across multiple states.
What is Infant Botulism and How Does it Occur?
Infant botulism is a rare and life-threatening condition that causes muscle weakness and paralysis in children one year old and younger. Studies show that most cases of infant botulism occur in children six months and younger. Babies can develop infant botulism when they ingest something that has Clostridium botulinum spores in it, such as the ByHeart Whole Nutrition infant formula. Once digested, the bacteria begins to multiply in the baby’s digestive system and forms a toxin, which then enters the bloodstream. After the toxin enters the bloodstream, it disrupts the baby’s nervous system, leading to a host of serious symptoms.
Symptoms of infant botulism include:
- Constipation
- Muscle weakness, including the baby being unable to hold their head
- Weak crying
- Poor feeding
- Difficulty swallowing or choking when trying to feed
- Decreased muscle tone
The symptoms typically come on gradually, sometimes making them hard to miss at first. However, without quick intervention, these symptoms can eventually lead to difficulty breathing and respiratory arrest.
What You Should Do if Your Child Developed Infant Botulism After Using ByHeart Formula
If your child shows any signs of infant botulism after using ByHeart Whole Nutrition infant formula, you should seek emergency medical care immediately. Infant botulism progresses quickly, and early treatment can prevent severe complications. Once your child is medically stabilized, consider taking the following steps to protect their health and your legal rights:
1. Preserve the formula and packaging
Keep any opened or unopened cans, packets, or scoops. These items may be important evidence for public health officials and any potential legal claim.
2. Document your child’s symptoms and diagnosis
Write down when symptoms began, how they progressed, and what your child’s medical team has diagnosed or observed. Save all medical records, hospital bills, discharge papers, and follow-up instructions.
3. Stop using the formula entirely
Because all lot numbers have been recalled, discontinue use even if your child is not showing symptoms. Safely store or set aside the product until you receive official instructions on disposal or return.
4. Report the illness to federal health officials
You can submit a report to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program. These reports help federal agencies track the outbreak and coordinate recalls.
5. Speak with an attorney experienced in product-related injuries
Infant botulism can lead to extensive hospitalizations, long-term monitoring, and serious complications. An attorney can help you understand your options, gather necessary documentation, and pursue compensation for medical care, future treatment needs, and related costs.
Call Anapol Weiss for Legal Guidance
Protecting your child’s health is the immediate priority, but you also deserve clarity about what went wrong and how to move forward safely. If your family was affected by the ByHeart infant formula recall, legal guidance can help you navigate the next steps with confidence and ensure your child’s well-being remains the top priority. Call Anapol Weiss today to discuss your baby formula case. We can be reached at 215-608-9645 or via our online contact form.
Disclaimer: This blog is intended for informational purposes only and does not establish an attorney-client relationship. It should not be considered as legal advice. For personalized legal assistance, please consult our team directly.
