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Federal health officials are investigating a growing outbreak of infant botulism linked to ByHeart baby formula, with at least 15 babies sick across 12 states.

The US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) confirmed the cases Monday, saying the illnesses appear tied to specific lots of ByHeart's "Whole Nutrition Infant Formula."

According to California health officer Dr. Erica Pan, nine cases of botulism type A have been confirmed so far, while tests for six additional cases are still pending.

"These mice got sick really quickly," Dr. Pan said, referring to lab tests that identified the bacteria responsible for the outbreak. No deaths have been reported, but every affected infant has been hospitalized.

ByHeart, an organic baby formula company based in New York, has voluntarily recalled two lots of its "Whole Nutrition Infant Formula."

According to AP News, the recalled lots are 206VABP/251261P2 and 206VABP/251131P2, both marked with "Use By" dates of December 2026.

Officials are urging consumers to immediately stop using these products and safely discard them.

The formula, which sells online and at major retailers, was fed to infants between August and November.

Testing of an open can from one sick baby's home confirmed the presence of bacteria that can cause botulism, a rare but serious illness that affects the nervous system.

ByHeart Recall Won't Affect Formula Supply

ByHeart said in a statement that it supports the FDA's investigation and is testing unopened cans from the affected batches.

"Testing unopened cans will provide reliable evidence that will help bring clarity to families who are understandably concerned," the company said.

Infant botulism typically affects fewer than 200 US babies each year.

It is caused by bacteria that produce a toxin in the intestines, leading to symptoms such as weakness, droopy eyelids, poor feeding, and breathing trouble.

Babies can become ill after ingesting contaminated food or spores found in the environment.

All of the infants linked to the ByHeart outbreak have received BabyBIG, the only FDA-approved treatment for infant botulism.

The medication, made from plasma donated by immunized adults, helps reduce hospital stays and recovery time.

Health officials emphasized that this recall will not cause a formula shortage, as ByHeart represents less than 1% of the US formula market, USA Today reported.

Parents who purchased the recalled formula should stop using it and contact ByHeart for a refund.

Consumers can reach the company at customercare@byheart.com or by phone at 786-810-7132.

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