Baby formula recalled in the US after several infants became ill with botulism.

Thirteen infants have been hospitalized with botulism, a potentially fatal condition, federal health authorities reported. Fortunately, no deaths have been reported to date, according to NBC News.

An organic baby food manufacturer is recalling some of its products after federal authorities linked them to an outbreak of infant botulism affecting 10 states.

The U.S. Food and Drug Administration (FDA) reported that 13 children have been hospitalized since August after consuming ByHeart Whole Nutrition Infant Formula. No deaths have been reported.

On November 8, the FDA announced that the recall affected two lots of the dry formula labeled "use by December 1." The lot numbers are 206VABP/251261P2 and 206VABP/251131P2.

The FDA urged parents and guardians who own these products to write down the identification information on the bottom of the package and discard it immediately. The agency also reportedly is working with retailers to remove "all potentially contaminated products" from store shelves.

Infant botulism is caused by a toxin produced by bacteria. It can lead to constipation, difficulty feeding, inability to hold the head up due to weakened neck muscles, difficulty swallowing, and ultimately paralysis and death, according to the Centers for Disease Control and Prevention (CDC).

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The FDA warned that parents and caregivers who have recently fed ByHeart formula to infants should closely monitor them as a precaution because botulism can develop over several weeks.

Cases of infant botulism associated with ByHeart formula have been reported in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

New York-based ByHeart announced that it received notification from the FDA on November 7 that approximately 83 cases of infant botulism have been reported nationwide since August, and that 13 infants consumed its formula. The company noted that government tests and its own investigations have not yet detected the presence of botulism in its products.

"ByHeart is taking proactive measures to eliminate any potential risk from the market and ensure maximum safety for infants," the company said in a statement. "The FDA has not found a direct link between any batches of infant formula and these cases. It has not previously been associated with infant botulism."

The FDA reported that authorities in several states are testing the remaining products, with results expected in the coming weeks. The agency is attempting to determine "the point of contamination and whether additional products are affected."

The California Department of Public Health has reported an increase in cases of infant botulism among infants who consumed ByHeart formula since August, the FDA confirmed.

On November 8, the California Department of Public Health (CDPH) announced it had identified an increase in cases of infant botulism linked to the formula and notified federal health authorities.

"CDPH tested a can of infant formula that was given to a child with botulism," the statement read. "Preliminary results indicate the presence of botulinum toxin-producing bacteria."

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According to the company's website, ByHeart formula is made from organic whole milk from grass-fed cows and, according to the manufacturer, is similar in composition to breast milk. The company has factories in Iowa, Pennsylvania, and Oregon, and its products are sold in nearly 12,000 retail locations.

According to the FDA, ByHeart products make up less than 1% of all baby formula sold in the United States.

According to the California Department of Public Health, infant botulism can be treated with BabyBIG, an FDA-approved orphan drug made from antibodies that fight botulinum neurotoxins.

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