On November 8th, ByHeart and the FDA announced a voluntary recall of its Infant formula due to concerns for possible contamination with Clostridium Botulinum, the bacteria that causes Botulism. Patients with these batches should immediately discontinue use of the formula and dispose of the product.

Batches affected by the recall are:

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

Importantly, currently this is a precautionary recall. To date, no direct link has been identified between the ByHeart Formula and Botulism. This recall is being made out of an abundance of caution while the FDA continues to investigate for any direct link.

A statement from the ByHeart company states “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.”

Botulism is a very rare condition that is caused by a toxin produced by the bacteria Clostridium Botulinum.  Early signs can be very vague and include:

• Constipation
• Poor feeding, weak suck
• Weak cry
• More sleepy, fatigued, tired than baseline
• Muscle weakness 

Later symptoms can include difficulty breathing or moving and require immediate medical attention.

If you are concerned that you child is showing any of the above signs please make an appointment to see your doctor or go to the emergency room.

Click on this link for the FDA announcement