INFANT FORMULA RECALL EXPANDS AS BOTULISM CASES SPREAD ACROSS 12 STATES — HERE’S WHAT PARENTS NEED TO KNOW

A nationwide recall of ByHeart’s Whole Nutrition Infant Formula has expanded as health officials investigate a growing cluster of infant botulism cases across 12 states.
The CDC and FDA say the recall was issued “out of an abundance of caution,” despite no unopened cans testing positive for contamination so far.

The recall includes all ByHeart Whole Nutrition Infant Formula products sold in the U.S., including both cans and the Anywhere Pack™ single-serve sticks.

🧪 What Sparked the Recall?

Since August 2025, health departments have reported an unusual rise in infant botulism cases—an illness caused by Clostridium botulinum—in babies who consumed ByHeart formula.

While the exact source of the contamination has not been confirmed, federal investigators say the recall is necessary due to the concentration of cases linked to the brand.

To date, 15 infants across 12 states have been hospitalized with confirmed or suspected cases.

📍 States Reporting Cases Connected to the Outbreak

According to the CDC, the affected states include:

• Arizona

• California

• Illinois

• Minnesota

• New Jersey

• Oregon

• Pennsylvania

• Rhode Island

• Texas

• Washington

• Kentucky

• North Carolina

The CDC stresses that additional states could be added as investigations continue.

⚠️ What Parents Should Do

Health authorities urge anyone who purchased ByHeart formula to:

• Stop using it immediately

• Discard or safely return the product per company instructions

• Sanitize all bottles and feeding equipment

• Monitor infants for symptoms, including:

  • Constipation

  • Weak sucking or feeding difficulty

  • Lethargy

  • Weak cry

  • Drooping eyelids

  • Breathing trouble

Parents noticing any symptoms are asked to seek medical care right away, as botulism can progress rapidly.

👶 Why This Matters

Infant botulism is extremely rare in the U.S., and powdered formula has never before been linked to a multi-state outbreak.
This makes the current investigation highly unusual and has prompted aggressive action from both federal and state health agencies.

ByHeart represents a small portion of the U.S. formula market, but its products have been disproportionately associated with cases under review.

📝 What’s Next

The FDA, CDC, and multiple state health departments are actively testing product samples, production facilities, and supply chains.
So far, no direct contamination point has been confirmed.

ByHeart says it is cooperating fully and expanded the recall voluntarily to protect families.

More updates will be provided as additional test results and investigation findings are released.