WASHINGTON — The U.S. Food and Drug Administration (FDA) has announced a recall of certain lots of ByHeart Whole Nutrition Infant Formula following a multi-state investigation into a cluster of infant botulism cases. The outbreak, which spans ten states, has resulted in 13 hospitalizations since August, though no deaths have been reported.
Federal health officials said the recall applies to two specific lots of ByHeart powdered formula with “use by” dates of December 1. The affected lot numbers are 206VABP/251261P2 and 206VABP/251131P2. The FDA has urged parents and caregivers to check the packaging and dispose of any formula from these batches immediately.
The agency said it is collaborating with retailers to ensure all potentially contaminated products are removed from store shelves. Investigators are continuing to test remaining supplies to determine how and where contamination may have occurred.
Infant botulism is caused by toxins produced by Clostridium botulinum, a bacterium that can lead to severe illness in infants. Symptoms include constipation, poor feeding, weak muscle tone, difficulty swallowing, and, in extreme cases, paralysis or respiratory failure. The Centers for Disease Control and Prevention (CDC) notes that while rare, infant botulism can be life-threatening if not treated promptly.
The FDA has received reports of infant botulism cases in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. Federal and state officials are working together to identify any shared sources of exposure.
In a statement, New York City-based ByHeart said it was notified on Friday that the FDA had linked its product to several of the infant botulism cases. The company said preliminary tests conducted by both the government and its own laboratories have not yet confirmed contamination in its 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 company said. “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 FDA confirmed that multiple state laboratories are testing leftover samples of the formula from affected households. Results are expected in the coming weeks as investigators work to pinpoint whether the contamination originated during production, storage, or transportation. Officials have not ruled out other environmental factors that could have contributed to the outbreak.
The California Department of Public Health also reported a rise in infant botulism cases among babies who had consumed ByHeart formula since August, according to the FDA. The department reminded parents to monitor their children for symptoms and seek immediate medical care if any appear.
ByHeart, known for producing organic, grass-fed whole milk formula marketed as being nutritionally close to breast milk, operates manufacturing facilities in Iowa, Pennsylvania, and Oregon. The company’s products are distributed through nearly 12,000 retailers across the United States. Despite its growing popularity, ByHeart represents less than one percent of the baby formula market nationwide, according to the FDA.
The agency reiterated that parents who recently used the affected product should watch for signs of illness, as botulism symptoms can take several weeks to develop. Health officials emphasized that prompt medical treatment, including the FDA-approved drug BabyBIG — an antibody-based therapy — can significantly improve recovery outcomes for infants diagnosed with the condition.
As the investigation continues, the FDA and CDC are urging caregivers to use only formula from verified, uncontaminated sources and to maintain careful hygiene when preparing baby formula. Parents are also encouraged to report any unusual symptoms or suspected contamination through the FDA’s consumer complaint portal.
The recall underscores ongoing challenges in maintaining safety in the infant nutrition market following previous national formula shortages and recalls. Both federal agencies have assured the public that they are prioritizing swift action to protect families and restore confidence in the safety of infant products sold across the country.
