Baby formula recalled after two Illinois infants showed signs of botulism
ByHeart infant formula has been recalled after the product has been linked to two suspected cases of botulism in infants in Illinois, according to the Illinois Department of Public Health.
Fox – 32 Chicago
ByHeart, a next-generation infant nutrition company, announced a voluntary recall of some batches of its infant formula after federal authorities linked it to an outbreak of infant botulism.
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention announced in separate statements on November 8 that two lots of Byheart Whole Nutrition Infant Milk were recalled. The CDC announced that 13 cases of infant botulism in 10 states have been linked to the formula.
All cases resulted in hospitalization, the CDC said. No deaths have been reported as of November 9th.
The FDA said the prescription was distributed online nationwide. The recalled formula accounts for less than 1% of all infant formula sold in the U.S. and there are no shortage concerns, officials said.
The CDC said the Infant Botulism Treatment and Prevention Program, part of the California Department of Public Health, is investigating the outbreak “associated with recalled infant formula.” The state’s program to develop and provide the world’s only drug to treat infant botulism alerted the CDC to the potential outbreak, the California Department of Public Health said.
The FDA said testing of the remaining baby formula is underway. Results are expected in the coming weeks.
Byheart denied linking to its products in a statement on its website, saying: “No associated toxins have been found in Byheart products.”
“Nonetheless, we have decided to take this step to eliminate potential risks from the market and ensure that the safety and health of all babies using ByHeart (including our own) is always our top priority,” the company added.
Here’s what you need to know about the infant formula botulism recall.
What ByHeart products are subject to recall?
Two lots of ByHeart Whole Nutrition Infant Milk are being recalled.
- Lot: 206VABP/251261P2, “use by” December 1, 2026
- Lot: 206VABP/251131P2, “use by” December 1, 2026
According to the company, the recalled lots were manufactured on April 23rd and May 6th. Lots were distributed primarily in July and August.
Byheart advised anyone in possession of the recalled milk powder cans to immediately throw away the product and offered to replace it free of charge.
Where are the cases of infant botulism?
Federal officials announced that cases of infant botulism related to the recall occurred in the following areas:
- arizona
- California
- illinois
- minnesota
- new jersey
- Oregon
- pennsylvania
- rhode island
- texas
- washington
According to the FDA’s Nov. 8 announcement, California, Illinois, and Texas each had two cases.
What are the symptoms of infant botulism?
According to the CDC, most infants with infant botulism first develop constipation, poor feeding, loss of head control, and difficulty swallowing. If left untreated, infants can experience progressive flaccid paralysis, have difficulty breathing, and require hospitalization for several weeks.
According to the Cleveland Clinic, symptoms of infant botulism include:
- If you try to feed it, it will choke.
- constipation.
- The sucking force may be weak, or the ability to suckle may decrease.
- Eyelids droop.
- Lack of facial expressions, inability to raise the head, or other signs of muscle weakness or paralysis.
- The cries become weaker.
- Weakness or loss of muscle tone, especially in the upper parts of the body and limbs, causing the baby to feel squishy and unable to reach or grasp.
- Changes in bowel movements, such as not pooping for days or weeks at a time.
