Federal health officials are investigating an outbreak of a rare infant disease in 10 states linked to baby formula that was being recalled, officials said.
At least 13 cases of infant botulism were recorded by Saturday following a recall of ByHeart Inc.’s Whole Nutrition Infant Formula, the Food and Drug Administration said in a statement.
All the babies were hospitalized after consuming formula from the lots labeled: 206VABP/251261P2 and 206VABP/251131P2.
The cases were reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.
Infant botulism is caused by a specific bacterium that produces toxins in the large intestine.
The disease typically causes the babies to develop constipation, poor feeding, loss of head control, and difficulty swallowing, according to the FDA.
The symptoms can worsen to difficulty breathing and respiratory arrest, and it can even result in death.
No deaths have been reported so far as part of the outbreak, the FDA stressed.
The agency is working to determine how the contaminations happened and if any other products were affected.
The contaminated baby formula, which was available at major retailers nationwide and online, accounted for an estimated 1% of national formula sales, according to the Centers for Disease Control and Prevention.
Caregivers who bought the recalled formula are advised to use dishwater or hot, soapy water to clean any items or surfaces that touched the contaminated product.
The FDA also urged care takers to seek immediate medicare help if an infant that has consumed the formula begins experiencing poor feeding, loss of head control, difficulty swallowing or decreased facial expression.
ByHeart claimed their products are not linked to the outbreak in infant botulism, and that the recall was made out of an “abundance of caution” following the FDA’s investigation.
“It’s important to know that the FDA has never found a direct link between infant formula and infant botulism, and no related toxins have been found in any ByHeart product,” the company said in a statement.
“Still, we decided to take this step to remove any potential risk from the market and ensure that the safety and well-being of every baby who uses ByHeart — including our own — will always come first,” ByHeart added.
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