ByHeart Baby Formula Recall: Infant Botulism Cases Rise to 51 Across 19 States

Federal health officials are investigating a growing outbreak of infant botulism linked to ByHeart baby formula. According to the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), at least 51 infants across 19 states have been hospitalized after consuming the recalled product.

The reported case count increased from 39 to 51 infants in just one week, signaling that the outbreak is ongoing and broader than initially understood. While no deaths have been reported, infant botulism is a serious and potentially life-threatening illness that often requires hospitalization and intensive medical care.

What Happened?

Infant botulism occurs when toxin-producing bacteria grow in a baby’s intestines and release a powerful neurotoxin that interferes with nerve signaling. Unlike foodborne botulism in adults, symptoms in infants may develop gradually and can be difficult to detect in early stages.

Health officials determined that infants who consumed ByHeart infant formula may have been exposed to the bacteria responsible for the illness. After notification from the FDA of a broader investigation, ByHeart issued a nationwide recall covering all batches of its infant formula, including cans and single-serve “anywhere pack” sticks.

The FDA confirmed the recalled product has not appeared in stores since November 26, 2025.

Who’s Affected?

Reported cases involve infants as young as two weeks old and up to eight months of age. Illnesses have been identified in:

Arizona, California, Idaho, Illinois, Kentucky, Massachusetts, Maine, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Virginia, Washington, and Wisconsin.

According to the CDC, cases date back to December 24, 2023, with additional cases identified through July 2025. Because symptoms may take time to appear, families whose infants consumed the formula during this period are encouraged to remain alert.

Symptoms and Potential Harms

Infant botulism is rare - typically affecting fewer than 200 babies per year in the U.S. - but it is considered a medical emergency. Symptoms may include:

• Weak or floppy muscle tone
• Difficulty feeding or sucking
• Constipation
• Weak or altered cry
• Breathing difficulties
• Progressive paralysis in severe cases

Infants diagnosed with botulism often require prolonged hospitalization. Recovery can take weeks or months, and some children may need ongoing medical monitoring.

Outbreak Growth Overview

What Families Can Do Now

• Stop using recalled formula immediately
• Seek medical care if any symptoms appear
• Preserve evidence such as containers, packaging, and receipts
• Document medical care including diagnoses and hospital stays

Families who purchased ByHeart formula in retail stores may request refunds directly from the retailer, subject to the retailer’s refund policy.

How Pursuing Can Help

Cases involving infant injuries and recalled baby products can be complex. Pursuing helps families understand their options and connects them with attorneys who are actively handling infant formula and baby food injury cases.

Our platform helps determine whether your situation may qualify for review and facilitates connections with legal professionals experienced in this specific type of claim.

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