ByHeart Formula Botulism 2025: 31 Babies Hospitalized – Recall Crisis

A nationwide recall of ByHeart infant formula has turned into a full-blown public health crisis as the number of confirmed infant botulism cases climbed to 31 babies across 15 states — and state officials confirm the dangerous recalled product is still being sold in stores weeks later.

Federal health authorities confirmed Wednesday that all hospitalized infants, aged 2 weeks to 6 months, consumed ByHeart formula before developing life-threatening botulism symptoms. The most recent case was reported on November 13, 2025.

While no deaths have been recorded, infant botulism can cause paralysis, breathing failure, and requires immediate emergency treatment with BabyBIG (Botulism Immune Globulin).

Recalled ByHeart Formula Still Found on Shelves

Despite the nationwide recall announced earlier this month, investigators in Oregon, Minnesota, and Arizona discovered ByHeart cans and single-serve sticks still for sale:

Oregon: 9 out of 150+ stores still had product this week
Minnesota: Removed recalled formula from 4 stores between Nov 13–17
Arizona: Confirmed ongoing availability in retail locations

State officials warn that some stores may have missed the recall notice entirely.

What Parents Must Do Immediately

Health officials urge every parent and caregiver to:

Check pantries and diaper bags for ANY ByHeart formula (cans or sticks)
Stop feeding it to babies immediately
Write “DO NOT USE – RECALLED” on the container and keep for 30+ days in case symptoms appear later
Contact your pediatrician at the first sign of constipation, weak cry, droopy eyelids, or floppy movements
Call California’s emergency hotline: 833-398-2022 (7 a.m.–11 p.m. PT)

Where Was ByHeart Formula Sold?

The recalled formula was widely available at:

Target
Walmart (removed nationwide & offering full refunds)
Amazon and direct from ByHeart website
Independent baby stores and pharmacies

Price per can: approximately $42–$45.

Ongoing Investigation & Company Response

The FDA is inspecting ByHeart plants in Iowa and Oregon. So far, no unopened cans have tested positive, but an opened can used for an affected California baby did contain the dangerous bacteria.

ByHeart insists the recall was voluntary and done “out of an abundance of caution,” but parents and regulators remain deeply concerned about distribution failures.

California’s Infant Botulism Treatment and Prevention Program reports their hotline has been overwhelmed with hundreds of panicked calls since the outbreak went public.

Infant Botulism: A Rare but Devastating Emergency

Infant botulism occurs when bacterial spores (Clostridium botulinum) grow in a baby’s intestines and release deadly toxin. Unlike adults, infants under 12 months cannot fight the bacteria naturally.

Symptoms usually appear 3–30 days after exposure and progress rapidly. Early treatment with BabyBIG is critical — delays can lead to respiratory failure requiring weeks on a ventilator.

This is one of the largest infant botulism clusters linked to commercial formula in U.S. history.