The U.S. Food and Drug Administration is investigating a series of infant botulism cases potentially linked to powdered baby formula.
Two of the cases were reported in Illinois, and an unspecified number of cases was reported in Minnesota.
The formula in question is manufactured by ByHeart, which announced a voluntary recall of two batches of its Whole Nutrition Infant Formula following notification from the FDA.
“This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents,” the company said in a statement. “While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”
The voluntary recall applies to the following two batches of ByHeart infant formula:
Batch Code: 251261P2, Use by: 01 Dec 2026 Batch Code: 251131P2, Use by: 01 Dec 2026 UPC: 5004496800 Image of voluntarily recalled infant formula from ByHeartWhat Is Infant Botulism?
Infant botulism is a rare but serious illness caused by Clostridium botulinum bacteria. According to the FDA, symptoms may include:
Constipation Poor feeding Drooping eyelids Sluggish pupils Low muscle tone Difficulty sucking or swallowing Weak or altered cry Generalized weakness Respiratory difficulty or arrestThe FDA warns that infant botulism can be fatal if not treated promptly.
Impact on Formula Supply
ByHeart’s formula accounts for less than 1% of all infant formula sold in the U.S., and the FDA says the recall is not expected to affect nationwide supply or contribute to a formula shortage.
Are Other Brands Involved?
Since August, the FDA has received 83 reports of botulism potentially tied to infant formula. NBC 5 has asked the agency for the names of other brands involved, but no additional information has been released.
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