• Posted November 12, 2025

ByHeart Expands Infant Formula Recall Nationwide as Investigation Continues

ByHeart Inc. has announced a full recall of all its Whole Nutrition Infant Formula products due to concerns about potential contamination leading to infant botulism.

To date, the outbreak has affected 15 babies in 12 states. 

The decision to expand the recall was made late Monday after the U.S. Food and Drug Administration (FDA) informed the company of two additional cases of infant botulism in babies who had consumed the formula. 

The recall now covers all lot numbers and all can sizes as well as single-serve Anywhere Pack sticks of ByHeart Whole Nutrition Infant Formula sold nationwide.

The FDA and the U.S. Centers for Disease Control and Prevention (CDC) are investigating the source of the outbreak. ByHeart emphasized that neither the company nor federal agencies has found Clostridium botulinum spores or toxins in any unopened can of formula during testing.

The company's co-founders issued an apology to parents.

“We are so sorry for the immense anxiety and fear that we have been causing you these past few days," it said. "Your baby’s safety is, and always will be, our biggest priority.”

Parents should stop using all ByHeart formula immediately and discard the product. The company has committed to providing the FDA with unrestricted access to its facilities for the ongoing investigation.

Earlier in the week, federal health officials announced a recall of only two lots of the powerdered formula. The expanded recall now covers all ByHeart formula products.

Although botulism can be fatal, no deaths have been reported in the now 12-state outbreak, according the to the CDC.

Infant botulism is a rare but serious condition caused by a toxin produced by Clostridium botulinum bacteria.

Symptoms may include constipation, poor feeding, difficulty swallowing, decreased facial expression and loss of head control, according to the CDC.

Parents should seek immediate medical care if they notice any of these symptoms. It can take several weeks from the time of exposure for the illness to develop.

CDC also recommends that parents and caregivers wash all surfaces and utensils that may have come into contact with the recalled formula with hot soapy water or dishwasher cleaning.

To date, suspected or confirmed cases have been identified in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, Washington, Kentucky and North Carolina. The formula is sold nationwide and online.

Health officials continue to investigate the precise point of contamination.

Treatment for infant botulism is available through an FDA-approved drug called BabyBIG, which uses antibodies to fight the toxins, NBC News reported.

More information

The U.S. Centers for Disease Control and Prevention (CDC) has more information regarding infant botulism symptoms.

SOURCES: U.S. Centers for Disease Control and Prevention, update, Nov. 11, 2025; ByHeart, statement, Nov. 11, 2025; NBC News, Nov. 8, 2025