Infant Formula Recall Expands Amid Growing Botulism Outbreak

Federal health agencies issue nationwide warning

Federal health officials have issued an urgent advisory urging all caregivers to stop using any ByHeart powdered infant formula immediately. The directive follows a surge in botulism cases that have hospitalized 15 infants across 12 states.

What happened?

The Centers for Disease Control and Prevention (CDC) confirmed that the affected infants tested positive for Clostridium botulinum toxin, the bacterium that causes botulism. Preliminary investigations traced the source to several batches of ByHeart’s powdered formula, prompting a broad recall.

Scope of the recall

The recall covers all ByHeart powdered formula products manufactured between January 2023 and August 2025, regardless of lot number or expiration date. Retailers have been instructed to remove the items from shelves and to provide refunds or replacements to customers.

Symptoms parents should watch for

Infants with botulism may exhibit:

• Weakness or floppiness
• Difficulty feeding or sucking
• Constipation
• Respiratory distress

If any of these signs appear, caregivers should seek medical attention immediately, even if the infant has not consumed the recalled formula.

Steps for caregivers

1. Stop using ByHeart formula at once.
2. Check the packaging for any ByHeart branding, even if the label looks different.
3. Contact the manufacturer at 1‑800‑555‑0123 for instructions on returning the product.
4. Consult a pediatrician about alternative feeding options.
5. Report any adverse symptoms to your local health department.

Official responses

The Food and Drug Administration (FDA) announced that it is working closely with ByHeart to investigate the contamination source and to ensure that future production meets safety standards. A spokesperson said, “We are committed to protecting the health of infants and will take every necessary action to prevent further cases.”

Impact and outlook

The outbreak underscores the vulnerability of the infant nutrition supply chain. Public health experts emphasize the importance of rapid reporting and transparent communication to mitigate risks. While the recall is extensive, officials remain hopeful that swift action will curb the spread of botulism and safeguard the health of infants nationwide.