Baby Formula Recalled After Botulism Case In NJ, Other States

A baby nutrition company is voluntarily recalling one of its products sold in New Jersey following an ongoing investigation into an outbreak of infant botulism, federal officials said.

ByHeart is recalling two batches of ByHeart Whole Nutrition Infant Formula after the U.S. Food and Drug Administration reported that 13 babies in 10 states had consumed the formula at some point.

The cases occurred in Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington.

The FDA hasn't found a direct link between the formula and the botulism outbreak, and there is no historic precedent of infant formula causing infant botulism, officials said. About 83 cases of infant botulism have been reported in the U.S. since August 2025, according to the FDA.

“The safety and well-being of every infant who uses our formula is our absolute highest priority,” said Mia Funt, ByHeart co-founder and president. “We take any potential safety concern extremely seriously, and act quickly to protect families. As parents ourselves, we understand the concern this news may raise. This voluntary recall is out of an abundance of caution and comes from our ongoing commitment to transparency and safety for babies and their parents. While no testing by ByHeart or regulatory agencies has confirmed the presence of Clostridium botulinum spores or toxin in any ByHeart product, we are taking this proactive step to remove any potential risk from the market and ensure the highest level of safety for infants.”

The voluntary recall applies to the following two batches of ByHeart infant formula:

• Batch Code: 251261P2, Use by: 01 Dec 2026
• Batch Code: 251131P2, Use by: 01 Dec 2026
• UPC: 5004496800

The batch code and use by can be found on the bottom of the can. No other ByHeart batches are impacted by this voluntary recall.

Testing of the product is underway and results are expected in the coming weeks, FDA officials said.

Infant botulism is a rare, but potentially fatal disease. It is not typically found in dairy products or infant formula, and is naturally occurring in environmental sources like soil, select vegetables and dust.

Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty and possibly respiratory arrest.

Consumers who have purchased ByHeart infant formula from the identified batch codes should immediately stop using and throw it away. If you’ve discarded any formula from these batches, ByHeart will replace those cans at no cost.

If your child has symptoms, contact your health care provider immediately and report the illness to the FDA.

For more information, check out the FDA outbreak advisory and the company's recall announcement.