Handout image of recalled ByHeart Whole Nutrition Infant Formula.

ByHeart, a next-generation baby nutrition company, has announced a voluntary recall of some batches of its powdered infant formula after federal authorities linked the product to an infant botulism outbreak.

In separate statements on Nov. 8, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention said two lots of ByHeart Whole Nutrition Infant Formula were recalled. The CDC said 13 cases of infant botulism across 10 states were linked to the formula.

All the cases have resulted in hospitalizations, according to the CDC. No deaths were reported as of Nov. 9.

The formula was distributed online and nationwide, according to the FDA. The recalled formula makes up less than 1% of all infant formula sold in the United States and does not raise shortage concerns, the agency said.

The CDC said the Infant Botulism Treatment and Prevention Program, part of the California Department of Public Health, is investigating the outbreak "linked to recalled infant formula." The state program, which developed and provides the only source of infant botulism treatment in the world, alerted the CDC of the possible outbreak, the California Department of Public Health said.

Testing of leftover formula is underway, the FDA said. Results are expected in the coming weeks.

ByHeart denied the link to its products in a statement posted to its website and said "no related toxins have been found in any ByHeart product."

"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," the company added.

Here's what to know about the infant formula botulism recall.

What ByHeart products are being recalled?

Two lots of ByHeart's Whole Nutrition Infant Formula are being recalled:

  • Lot: 206VABP/251261P2 with a “use by" date of Dec. 1, 2026
  • Lot: 206VABP/251131P2 with a "use by" date of Dec. 1, 2026

The recalled lots were manufactured on April 23 and May 6, according to the company. The lots were primarily distributed in July and August.

ByHeart advised those with recalled cans of formula to dispose of the product immediately and offered to replace them at no cost.

Where are the cases of infant botulism?

Federal officials announced that the cases of infant botulism linked to the recall occurred in:

  • Arizona
  • California
  • Illinois
  • Minnesota
  • New Jersey
  • Oregon
  • Pennsylvania
  • Rhode Island
  • Texas
  • Washington

California, Illinois, and Texas each saw two cases, according to the FDA's Nov. 8 announcement.

What are the symptoms of infant botulism?

Most infants with infant botulism will initially develop constipation, poor feeding, loss of head control, and difficulty swallowing, according to the CDC. If left untreated, infants may experience a progressive, flaccid paralysis that can lead to breathing difficulties and require weeks of hospitalization.

According to the Cleveland Clinic, infant botulism symptoms include:

  • Choking when trying to feed.
  • Constipation.
  • Weaker suck or poor feeding.
  • Eyelid drooping.
  • Lack of facial expressions, being unable to lift their head, or other signs of muscle weakness or paralysis.
  • Weaker crying.
  • Weakness or decreased muscle tone, especially starting at the top of their body and limbs, making your baby feel "floppy" and keeping them from reaching or grabbing.
  • Bowel movement changes, like not pooping for days or even weeks at a time.

This article originally appeared on USA TODAY: ByHeart baby formula recalled amid infant botulism investigation

Reporting by James Powel, USA TODAY / USA TODAY

USA TODAY Network via Reuters Connect