The Louisiana Department of Health is working with retailers across the state to remove ByHeart Whole Nutrition Infant Formula from shelves following a potential contamination that could cause botulism in babies.
Last week, the Food and Drug Administration issued a warning about ByHeart formula, saying the product could potentially be contaminated with Clostridium botulinum, a bacterium that can be deadly to infants. On Tuesday, the company issued a voluntary recall of all powered whole nutrition formula.
No cases of infant botulism have been reported in Louisiana during the outbreak, but state health officials urged parents and caregivers to seek immediate medical care if an infant consumed ByHeart Whole Nutrition Infant formula or has developed any symptoms of infant botulism. Those symptoms — constipation, diminished feeding, loss of head control and difficulty swallowing — can take several weeks to appear.
Caregivers who recently purchased the formula and have not used it are advised to discard it or return it to the store. All items or surfaces that may have come in contact with the formula should be washed with hot soapy water or a dishwasher.
The FDA advised caregivers to record the information printed on the bottom of the package and store the product in a secure place without using it. State health officials may request the container for testing if symptoms emerge.
As of Friday, 23 infants with suspected or confirmed infant botulism and confirmed exposure to ByHeart formula have been hospitalized in 13 states, according to the FDA. No deaths have been reported.
At least two families have filed lawsuits in recent days over their children’s illnesses, national outlets reported.
Federal investigators earlier this year found multiple safety violations at a ByHeart manufacturing plant in Pennsylvania, including a leaking roof and dead insects near areas where formula was produced, according to a report by The New York Times.
The FDA said the national outbreak does not pose a risk of formula shortages, noting that ByHeart’s products account for approximately 1% of infant formula sales in the United States.
