Botulism Outbreak Prompts Nationwide Recall Of Baby Formula, 13 Hospitalized

A baby nutrition company has voluntarily recalled two batches of infant formula due to an outbreak of botulism across 10 states.

ByHeart recalled “two batches of ByHeart Whole Nutrition Infant Formula following notification from the U.S. Food and Drug Administration (FDA) of a broader ongoing investigation into a recent outbreak of infant botulism,” the FDA announced.

13 children have been hospitalized, the CDC noted.

No deaths have been reported.

Federal and state health officials are investigating 13 cases in 10 U.S. states of infant botulism linked to baby formula that is being recalled. https://t.co/aGK78ngUQm

— CBS News (@CBSNews) November 10, 2025

NBC News has more:

The recall includes two lots of the powdered formula with Dec. 1 “use by” dates, the FDA said in a statement Saturday. The lot numbers are 206VABP/251261P2 and 206VABP/251131P2.

The FDA asked parents and caregivers who have the product to record identifying information at the bottom of the packaging and promptly throw it away. It said it was working with retailers to remove “all potentially impacted product” from store shelves.

Infant botulism is a bacteria-produced toxin that can cause constipation, poor feeding, loss of head control, difficulty swallowing and can ultimately lead to paralysis and death, according to the Centers for Disease Control and Prevention.

The FDA said parents and caregivers who have fed ByHeart to children recently should keep a close eye on them as a precaution, as botulism can take weeks to develop.

“ByHeart was notified by the FDA on November 7, 2025 of an estimated 83 cases of infant botulism that were reported nationwide since August 2025. Of these, the FDA also noted that 13 infants received ByHeart formula at some point,” the FDA stated.

“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. Botulism is extremely uncommon in dairy products or infant formula, and is naturally occurring in environmental sources like soil, select vegetables, and dust,” it continued.

Outbreak Investigation of Infant Botulism – Do not use certain lots of ByHeart Whole Nutrition Infant Formula. FDA’s Investigation is ongoing. https://t.co/umKvtkWIEa pic.twitter.com/NwjMCsEkeS

— U.S. FDA (@US_FDA) November 8, 2025

Cincinnati Enquirer noted:

According to the CDC, symptoms of infant botulism may include:

• Respiratory difficulty and possibly respiratory failure
• Constipation
• Poor feeding
• Drooping eyelids (ptosis)
• Sluggish pupils
• Flattened facial expression
• Diminished suck and gag reflexes
• Weak and altered cry

Parents should seek immediate care for babies if they exhibit these symptoms.

The FDA is investigating 13 infant botulism cases in 10 states, including:

• Arizona
• California (2)
• Illinois (2)
• Minnesota
• New Jersey
• Oregon
• Pennsylvania
• Rhode Island
• Texas (2)
• Washington

Read the full FDA alert HERE.