Popular Baby Formula Pulled From Shelves in 10 States After Infant Botulism Scare

A dangerous virus in a children's food product infiltrated 10 states in the U.S. The Food and Drug Administration initiated a recall of ByHeart baby formula after an infant botulism outbreak. The recall announcement was made after officials linked infants' health conditions to the consumption of the ByHeart Whole Nutrition Infant Formula. According to the agency, 13 infants have been infected and hospitalized since August 2025. The situation has been critical, but thankfully, zero deaths have been reported. The recalled products are two lots of the baby formula with 1 Dec 2026 printed as their 'use by' dates. The lot numbers of the affected products are 206VABP/251261P2 and 206VABP/251131P2, as per the FDA.

The product information has been released to alert parents and caregivers, urging them to check the ByHeart baby formula product they may have in store. The product details are printed on the bottom of the infant formula can. ByHeart Whole Nutrition Infant Formula makes up less than 1% of infant baby food products in the market around the State. So, there are plenty of products besides the affected ones for adults to purchase. The FDA announced that they are working to remove “all potentially impacted products” from stores and supermarket chains.

The agency suggested that parents and caregivers throw away the affected products immediately if found in their pantry. Botulism is a rare condition produced by a toxin caused by Clostridium botulinum that directly attacks the nerves of infants, according to Mayo Clinic. It is a life-threatening bacteria that can create severe symptoms. Poor feeding, loss of head control, difficulty swallowing, or decreased facial expression are some of the major symptoms of botulism in infants. If any child is experiencing any of the above-mentioned symptoms, the FDA suggests getting a doctor's consultation. It's best to keep an eye out for symptoms in the upcoming weeks, as botulism can take that much time to develop signs.

The 10 states that witnessed a botulism outbreak due to ByHeart consumption are: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. So far, the FDA has recorded 83 reports across the U.S., and 13 children have been fed with the affected baby formula. “ByHeart is taking the proactive step to remove any potential risk from the market and ensure the highest level of safety for infants," the New York City-based company announced in a statement. Although children were hospitalized with infant the disease after consuming the product, testing by ByHeart or regulatory agencies couldn't find the presence of botulism-causing bacteria in the samples.

"The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism," the company announced. Nevertheless, the recall was initiated, and precautions are being taken by the company. “The safety and well-being of every infant who uses our formula is our absolute highest priority,” said Mia Funt, co-founder and president of ByHeart. “We take any potential safety concern extremely seriously and act quickly to protect families. This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents," she added.