Popular baby formula brand recalls product across 10 states amid infant botulism fears

It's not the best look for ByHeart, the company producing and selling the baby formula.

PUBLISHED NOV 10, 2025

Parents with child buying baby formula (Cover image source: Getty Images | Brandon Bell)

Food products have been pulled off shelves frequently as part of massive recalls in the past couple of years. While contamination risks pose a threat to consumers in general, any compromise on the quality of baby formula could have a grave impact on infants. Sometimes, products of even the most reputable companies can fall short of quality and safety standards. Baby formula manufactured by one such brand, ByHeart, has been recalled after being linked to a botulism outbreak among infants in 10 states.

Representative image of an infant. (Image Source: Getty Images| Photo by Catherine Delahaye)

Deaths caused by the formula have not been reported yet, but consumers have been told to return the product. The states in which these infant botulism cases have been reported are Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington, as per a report in NBC News. A statement by the FDA notes that the lot numbers are 206VABP/251261P2 and 206VABP/251131P2.

“Parents and Caregivers should not use certain lots of ByHeart Whole Nutrition Infant Formula and should throw this product away immediately. If your child is experiencing symptoms (see below) after consuming ByHeart Whole Nutrition Infant Formula and you still have the formula in your home, please record the information on the bottom of the package before throwing it away,” the statement read.

Representative image of baby formula. (Image credit: Getty Images | Photo by Sod Tatong) — Representative image of baby formula. (Image source: Getty Images | Photo by Sod Tatong)

Despite recalling the product, ByHeart has not admitted that its baby formula is directly responsible for these cases of infant botulism. In fact, they even claimed that in-house tests and tests conducted by the FDA of their formula have not yet revealed a direct link to these botulism cases.

“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, and added, “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.”

Representative image of a lab test being conducted. (Image credit: Getty Images | Photo by Brandon Colbert Photography) — Representative image of a lab test being conducted. (Image source: Getty Images | Photo by Brandon Colbert Photography)

The botulism outbreak has been treated with utmost urgency, and the government has taken quick action even before a link between the product and cases was established. However, tests of the baby formula conducted by the California Department of Public Health (CDPH) have revealed that the product, in fact, contained bacteria that caused the disease.

“CDPH has tested a can of powdered infant formula that was fed to an infant with infant botulism. Preliminary results suggest the presence of the bacteria that produce botulinum toxin, consistent with the same toxin reported in the confirmed infant cases,” the CDPH said in a statement, before mentioning, “CDC, CDPH, and other state health departments are investigating 13 suspected or confirmed infant botulism cases linked to ByHeart powdered infant formula across 10 states.”