Baby formula linked to infant botulism cases in Oregon and nine other states is being recalled after federal authorities said the bacteria that produces the toxin was found in the formula.

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 California Department of Public Health noticed the increase in infant botulism cases in babies who drank ByHeart powdered infant formula and alerted the CDC. The agency also tested an open can that was fed to a baby with botulism and preliminary results indicated the presence of the bacteria that produce botulinum toxin.

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

ByHeart agreed to a voluntary recall of the two lots, but denied the validity of the test that found the toxin and said it was conducting its own additional testing.

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.

All 13 cases have resulted in hospitalizations, according to the CDC. No deaths were reported as of Nov. 10. One case has been reported in Oregon.

ByHeart Whole Nutrition Infant Formula has been linked to 13 infant botulism cases.

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.

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.

Isabel Funk covers breaking news and public safety for the Statesman Journal. Funk can be reached at ifunk@statesmanjournal.com or on X at @isabeldfunk

This article originally appeared on Salem Statesman Journal: ByHeart recalls baby formula linked to botulism in Oregon