Key Development

More than 50 babies in the United States have fallen sick with infant botulism after consuming contaminated ByHeart powdered infant formula, according to federal health officials. Botulism is a rare but serious illness that can cause paralysis and even death. The U.S. Food and Drug Administration (FDA) reported 51 confirmed or suspected cases across 19 states. This is up from 39 cases reported earlier this month. The updated case count now includes illnesses dating back to December 2023. All 51 infants were hospitalized, but no deaths have been recorded. The affected babies are between 2 weeks and 5 months old.

States Affected

Cases have been reported across the country, including California, Arizona, Michigan, Texas, Virginia, Washington, North Carolina, and Ohio, which was recently added to the list.

Recalled Formula Not Found in Stores Recently

The FDA said it hasn’t received any new complaints about recalled formula appearing on store shelves since November 26, 2025. The agency confirmed that all ByHeart formula products were recalled, including cans and single-serve sticks. However, some customers earlier claimed they still saw the product in stores like Walmart, Target, and Kroger.

What Parents Should Do

ByHeart has advised parents to stop using the recalled formula immediately and dispose of it. The FDA listed two recalled lots of ByHeart Whole Nutrition Infant Formula:

• Lot 206VABP/251261P2 (Use by 01 Dec 2026)
• Lot 206VABP/251131P2 (Use by 01 Dec 2026)

Testing by ByHeart, the FDA, the CDC, and state labs is still ongoing.

How the Outbreak Was Identified

California health officials confirmed that an open can of ByHeart formula from an affected baby’s home tested positive for bacteria that produce the botulism toxin. Tests involved injecting lab mice with samples, and “the mice fell sick very quickly,” said Dr Erica Pan, the state health officer. No other formula brands have been linked to the outbreak.

ByHeart said it recalled the batches voluntarily and is working with independent labs to confirm contamination. The company noted that unopened cans have not tested positive so far, and contamination could also come from environmental sources.

Understanding Infant Botulism

Botulism is a rare but serious illness caused by a toxin made by the bacteria Clostridium botulinum. It can cause paralysis and, in severe cases, death.

Infant Botulism

In babies under 1 year, the bacteria can grow in their intestines and release toxins. This can make infants weak, floppy, and have trouble feeding or breathing. Infant botulism is most often linked to honey, contaminated formula, or environmental spores. Symptoms can appear slowly and may include:

• Poor feeding
• Loss of head control
• Drooping eyelids
• Weak or “floppy” body
• Difficulty breathing or swallowing

Will the Recall Cause a Formula Shortage?

Experts say no major shortage is expected, because ByHeart holds only about 1% of the U.S. formula market. This situation is not like the 2021–2022 formula crisis involving Abbott Nutrition. ByHeart faced previous scrutiny, including a 2022 recall due to contamination at its packaging plant and an FDA warning letter in 2023 highlighting needed corrections.

Source: Livenowfox