Two batches of a baby formula possibly linked to an infant botulism outbreak got recalled Saturday, a nationwide recall that multistate chains Publix and Meijer announced via their websites.
Here’s what you need to know about the outbreak and ByHeart Whole Nutrition Infant Formula:
What formula has been recalled?
ByHeart recalled its Whole Nutrition Infant Formula, lot Nos. 206VABP/251261P2 and 206VABP/251131P2. Both have use by dates of December 1, 2026.
The FDA, clearly recalling the panic after the 2022 Abbott baby formula recall caused a sudden shortage, stated in Saturday’s outbreak update, “ByHeart Whole Nutrition Infant Formula makes up an estimated less than 1% of all infant formula sold in the United States, and this outbreak does not create shortage concerns of infant formula for parents and caregivers.”
Return recalled formula to the store for a full refund. Direct questions to ByHeart at hello@byheart.com, call 833-429-4327 or go to ByHeart’s website.
“The safety and well-being of every infant who uses our formula is our absolute highest priority,” ByHeart Co-Founder and President Mia Funt said in a statement included with the recall announcement. “We take any potential safety concern extremely seriously, and act quickly to protect families. As parents ourselves, we understand the concern this news may raise. 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.”
“While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”
Information about the outbreak
While ByHeart says 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 state of California said something different.
The California Department of Public Health’s Infant Botulism Treatment and Prevention Program, according to the FDA, first reported an “increase in botulism type A infection among infants consuming ByHeart powdered infant formula from August to November 2025.
“We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive,” said Dr. Erica Pan, California Department of Public Health Director and State Public Health Officer, in a Saturday statement. “We are urging parents to stop using ByHeart formula immediately.”
ByHeart’s recall notice admitted that the FDA, on Friday, said 13 of 83 babies reported to be infected with infant botulism nationwide had consumed ByHeart formula. The FDA recommended ByHeart issue a recall.
The FDA and CDC are counting only those 13 babies as being in the outbreak. California, Texas and Illinois each have two children sick. Washington, Pennsylvania, Arizona, Minnesota, New Jersey, Oregon and Rhode Island each have one.
What does infant botulism look like?
“Infant botulism often starts with constipation but is usually first noticed as difficulty feeding (sucking and swallowing), a weak and altered cry, and loss of muscle tone,” the Centers for Disease Control and Prevention said. “If untreated, infants with infant botulism experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.” The CDC advises to take your baby to a doctor if they had ByHeart’s recalled formula and began to show a loss of head control, less facial expression and begins to have a hard time swallowing.
By DAVID J. NEAL/Miami Herald
Since 1989, David J. Neal’s domain at the Miami Herald has expanded to include writing about Panthers (NHL and FIU), Dolphins, old school animation, food safety, fraud, naughty lawyers, bad doctors and all manner of breaking news. He drinks coladas whole. He does not work Indianapolis 500 Race Day.
