WASHINGTON, DC – Federal health officials warn that recalled infant formula linked to a growing botulism outbreak may still be sitting on store shelves, as hospitalization numbers continue to climb across the country.
The Food and Drug Administration reported 31 suspected or confirmed cases of infant botulism on Thursday involving babies who consumed ByHeart Whole Nutrition formula between August and mid-November. All affected infants required hospitalization, though no deaths have been reported.
The outbreak spans 15 states including California, Texas, Michigan, Pennsylvania, and Washington. California’s Department of Public Health first confirmed the presence of *Clostridium botulinum* bacteria in formula samples earlier this month, prompting an initial recall of two product batches.
ByHeart expanded the recall the following week to include all of its formula products nationwide. The company, which entered the competitive infant formula market in 2022, represents approximately 1% of total U.S. formula sales.
Company officials acknowledged that *Clostridium botulinum* was not among pathogens routinely tested for across the industry prior to this outbreak. The discovery has prompted industry-wide changes to testing protocols, according to ByHeart representatives.
Infant botulism causes progressive paralysis that can impair breathing. Symptoms typically appear 3-30 days after exposure and initially include constipation, poor feeding, and difficulty swallowing. Medical treatment involves administering an antitoxin called BabyBIG intravenously.
Parents of affected infants have filed multiple lawsuits seeking compensation for medical bills and emotional distress. The legal actions name both ByHeart and its manufacturing partners as defendants.
Health officials urge parents to check their homes for any ByHeart formula products and return them to retailers for full refunds. Retailers are being instructed to remove all remaining stock from shelves immediately.
The outbreak represents one of the largest infant formula safety incidents in recent years. Federal investigators continue examining manufacturing facilities to determine the contamination source.
