The discovery that a trusted baby-formula brand may have caused serious illness or death has left parents across the country searching for answers. On November 8th 2025, the Food and Drug Administration and Centers for Disease Control and Prevention announced an investigation into a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula.
As new reports emerged, ByHeart issued a nationwide recall, and hospitals, clinics, and retailers began pulling products from shelves. For families who relied on this formula, the news is heartbreaking and it raises urgent questions about safety, accountability, and next steps.
What the Recall Covers
On November 11, 2025, ByHeart expanded its voluntary recall to include:
- All ByHeart Whole Nutrition Infant Formula cans
- All Anywhere Pack single-serve sticks
Parents were urged to stop using the product immediately and request a refund directly from the company. The FDA confirmed that an opened container tested positive for bacteria capable of producing botulinum toxin, the cause of infant botulism.
Read Official the FDA recall announcement →
What Is Infant Botulism
Infant botulism is a rare but severe illness caused when Clostridium botulinum spores grow inside the intestines and release toxins that affect the nervous system. It can develop gradually, and early symptoms often go unnoticed until they become life-threatening.
Common signs include:
- Constipation or reduced bowel movements
- Weak cry or difficulty sucking
- Drooling, lethargy, or “floppy” body
- Difficulty swallowing or breathing
Prompt medical attention is critical. Hospitals typically treat infant botulism with an antitoxin called BabyBIG®, along with intensive supportive care.
What Parents Should Do Now About the ByHeart Formula Recall
1. Stop using immediately
Stop using all ByHeart formula, regardless of lot code or packaging. Do not donate or share it.
2. Preserve evidence
Keep all cans, packaging, lot numbers, purchase receipts, and medical records. Store products in sealed bags labeled “Do Not Use.”
3. Contact your pediatrician
If your baby consumed ByHeart formula within the past month, schedule a check-up. Mention the brand name and recall details so your doctor can evaluate for early symptoms.
4. Clean and sanitize surfaces
Wash bottles, scoops, and any utensils or counters that came into contact with the formula.
5. Report illness
Submit a report to the FDA MedWatch portal and your state’s health department if your child experiences symptoms or receives a diagnosis linked to the recalled product.
Why This Recall Matters
The ByHeart recall has sparked concern not only for affected families but also for hospital and retail supply chains that distributed the product. While ByHeart represents only a small percent of the U.S. infant-formula market, its overrepresentation among reported botulism cases raises questions about manufacturing practices and regulatory oversight.
Consumer advocates and pediatric health experts have criticized the company’s early public statements, calling the company’s initial statements “bizzare”, which only deepened public anxiety.
Investigators are still determining how contamination may have occurred, but the FDA’s decision to extend the recall to all lots reflects the seriousness of the potential threat.
What Are Your Legal Options?
Families whose children became ill, or worse, after consuming contaminated formula may have rights under product-liability and wrongful-death laws. Potential legal claims may involve:
- Contamination or defective manufacturing processes
- Failure to warn about contamination risk
- Negligent testing or sanitation practices
- Distribution of unsafe batches to hospitals or retailers
As each situation is unique, but if the product was provided in a hospital setting, the matter may also involve elements of medical malpractice depending on how and when the formula was administered.
WCTL Stands With Families Impacted by the ByHeart Recall
West Coast Trial Lawyers have a long history of holding major corporations accountable when unsafe products harm consumers. Our attorneys have recovered millions for families in catastrophic-injury and defective-product cases across California and the U.S.
We work with medical specialists and product-safety experts to:
- Trace the contamination source and supply chain
- Review hospital and autopsy records when applicable
- Preserve and test remaining formula samples
- Demand full compensation for medical expenses, pain and suffering, and future care needs
The ByHeart recall is a stark reminder that product safety can never be taken for granted, especially when it involves infants. While the FDA and CDC continue their investigation, parents deserve clear information and access to legal support if their child was affected.
If your baby became sick after using ByHeart formula, or if you have questions about your family’s rights, West Coast Trial Lawyers are here to guide you every step of the way.
Call (213) 927-3700 or fill out our online form to schedule a free, confidential consultation. Our legal team is available 24/7.
