The U.S. Food and Drug Administration (FDA) is investigating a nationwide baby formula recall following reports of infant botulism, a rare but potentially fatal illness, in 10 states. At least 13 infants have been hospitalized after consuming specific batches of ByHeart Inc.’s Whole Nutrition Infant Formula, prompting urgent action from federal health officials.
What We Know About the Recall
According to the FDA, the recall affects ByHeart Whole Nutrition Infant Formula labeled with lot numbers 206VABP/251261P2 and 206VABP/251131P2. The formula was sold nationwide and online, accounting for approximately 1% of U.S. formula sales.
Cases of infant botulism have been confirmed in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. Thankfully, no deaths have been reported at this time.
Understanding Infant Botulism
Infant botulism occurs when Clostridium botulinum bacteria grow in a baby’s intestines and release toxins that affect the nervous system. Early symptoms include:
Constipation
Weak sucking or poor feeding
Loss of head control
Decreased facial expression
Difficulty swallowing
If untreated, symptoms can escalate to difficulty breathing or respiratory arrest. The FDA urges parents and caregivers to seek immediate medical attention if a child who consumed the recalled formula shows any of these warning signs.
Cleaning and Safety Precautions
Consumers who purchased the recalled formula should:
Stop using it immediately
Clean all bottles, utensils, and surfaces that came into contact with the product using hot, soapy water or a dishwasher
Monitor infants closely for any signs of illness
ByHeart’s Response
ByHeart, a Pennsylvania-based formula company, stated that the recall was issued “out of an abundance of caution” and emphasized that no direct link between their product and the outbreak has been proven.
“The FDA has never found a direct link between infant formula and infant botulism, and no related toxins have been found in any ByHeart product,” the company said.
“Still, we decided to take this step to remove any potential risk from the market and ensure that the safety and well-being of every baby who uses ByHeart — including our own — will always come first.”
What Families Should Do
If you or someone you know purchased ByHeart formula, check the packaging for the affected lot numbers. For more information, visit the FDA’s recall page or contact ByHeart customer service for a refund or replacement instructions.
Hilliard Law’s Commitment to Protecting Families
At Hilliard Law, we believe parents should never have to question the safety of the products they trust for their children. When companies fail to uphold that responsibility, our legal team stands ready to hold them accountable.
If your child became ill after consuming ByHeart or any recalled baby formula, you may have legal options. Our attorneys are experienced in product liability and consumer protection cases, and we are committed to pursuing justice for affected families.
Call Hilliard Law at (866) 927-3420 at any time to request a free consultation.