ByHeart Baby Formula Recall Over Suspected Infant Botulism: What Is It?

Liputan6.com, Jakarta The United States Food and Drug Administration (FDA) announced the recall of ByHeart Whole Nutrition Infant Formula on Saturday, November 8, 2025.

Thirteen infants in 10 US states have been hospitalized, according to NBC News.

While the FDA states that no direct link has been definitively identified between the infant formula and these botulism cases, the recall is voluntary by ByHeart Inc.

California health officials report that initial testing indicates the ByHeart infant formula linked to the botulism outbreak contains a toxin-producing strain of bacteria.

Outbreak Investigation of Infant Botulism - Do not use certain lots of ByHeart Whole Nutrition Infant Formula. FDA’s Investigation is ongoing. https://t.co/umKvtkWIEa pic.twitter.com/NwjMCsEkeS

— U.S. FDA (@US_FDA) November 8, 2025

The recall of ByHeart Whole Nutrition Infant Formula covers two specific batches: 251261P2 and 251131P2, also known as 206VABP/251261P2 and 206VABP/251131P2.

Both batches have a "Use By" date of December 1, 2026, which can be found on the bottom of the product packaging.

This recall is an over-the-counter precaution by ByHeart Inc. to ensure consumer safety.

As of November 8, 2025, 13 infants in states including Arizona, California, Illinois, and Texas have been hospitalized with suspected or confirmed infant botulism after consuming this formula.

All of the ill infants received BabyBIG® (Botulism Immune Globulin), and no deaths have been reported.

The FDA emphasizes that botulism is extremely rare in milk products or infant formula and is naturally found in environments such as soil.

In response to this infant botulism formula recall, parents and caregivers are strongly advised to take immediate precautions.

First, discontinue use of ByHeart Whole Nutrition Infant Formula from the recalled batch.

It is important to note the batch number before discarding the product or returning it to the place of purchase.

Second, ensure the cleanliness of equipment and surfaces that may have come into contact with the recalled formula.

Wash thoroughly in a dishwasher or with hot, soapy water to remove any potential contamination.

This action is crucial to prevent the spread of any bacteria.

Third, seek immediate medical attention if your baby has consumed the recalled formula and exhibits symptoms of botulism.

Botulism is a rare but serious disease caused by a powerful toxin produced by the bacterium Clostridium botulinum.

This toxin attacks the nervous system, causing muscle paralysis that can be fatal if not treated quickly and appropriately.

These types of botulism include foodborne botulism, which occurs from consuming contaminated food; wound botulism, which is caused by a bacterial infection in a wound; and iatrogenic botulism, which arises from excessive injection of botulinum toxin.

Infant botulism is the most common form of the disease, primarily affecting infants under one year of age.

The disease happens when Clostridium botulinum spores enter the infant's digestive tract, colonize, and produce toxin.