FDA Announces Recall of Infant Formula After Outbreak of Potentially Fatal Illness

On Nov. 8, 2025, the U.S. Food & Drug Administration (FDA) announced that ByHeart is voluntarily recalling two batches of ByHeart Whole Nutrition Infant Formula. The formula is being recalled out of an abundance of caution following an investigation by the FDA and Centers for Disease Control and Prevention (CDC) into a multistate outbreak of infant botulism.

The recall was initiated after the FDA notified ByHeart that of an estimated 83 cases of infant botulism reported between August 2025 and November 2025, 13 babies received ByHeart formula at some point.

It’s important to note that at this time, the FDA has not identified a direct link between ByHeart or any other infant formula and these cases of infant botulism, and “there is no historical precedent of infant formula causing infant botulism,” according to the FDA. However, ByHeart is taking a proactive step by recalling two batches of formula sold during this time to ensure the highest level of safety for infants.

Infant botulism is a rare illness that poses a serious and potentially fatal threat to babies. It occurs when Clostridium botulinum spores are ingested, producing botulinum neurotoxins in the digestive system of infants. Signs and symptoms of infant botulism include 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.

How To Identify the Recalled Baby Formula

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

• Batch Code: 251261P2; Use by: Dec. 1, 2026
• Batch Code: 251131P2; Use by: Dec. 1, 2026
• UPC: 5004496800

Other batches of ByHeart formula, as well as other brands of baby formula are not affected by this recall. You can find images of the recalled product labels on the FDA website.

What To Do if You Have the Recalled Baby Formula

Although the FDA has not yet established a direct link between ByHeart baby formula and the ongoing outbreak of botulism in infants, any consumers who have purchased the recalled ByHeart formula should immediately stop using it and dispose of any remaining product. ByHeart will replace any cans of recalled formula at no cost.

If your infant is exhibiting or experiencing symptoms related to infant botulism, contact your healthcare provider immediately. If you have questions regarding this recall, contact ByHeart at hello@byheart.com. For more information on the recall, you can also visit byheart.com or call 1-833-429-4327.