The ByHeart Company issues a recall of two batches of Whole Nutrition Infant Formula over botulism concerns.

 

The company issued the recall voluntarily after it was notified by the Food and Drug Administration of an ongoing investigation into reports of a recent outbreak of infant botulism. Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants which occurs when the botulism spores are ingested and colonize the intestinal tract, producing botulinum neurotoxins in the infants. Affected babies can show symptoms such as constipation, poor feeding, drooping eyelids, sluggish pupils, low muscle tone, difficulty nursing and swallowing, weak or altered cry, generalized weakness, and respiratory difficulty.

 

ByHeart was notified by the FDA of an estimated 83 cases of infant botulism that have been reported nationwide since August 2025. Of these, the FDA also noted that 13 infants received ByHeart formula at some point, but has not identified a direct link between the formula and the illness.

 

The recall applies to two batches of the ByHeart Whole Nutrition Infant Formula. Consumers who have purchased ByHeart infant formula from the identified batch codes should immediately discontinue use and dispose of the product. If you’ve discarded any formula from the following batches, ByHeart will replace those cans at no cost.

 

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
• Product Image : See below

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.

 

If your infant is experiencing symptoms related to infant botulism, contact your healthcare provider immediately.

 

If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately. To report an illness or adverse event, you can:

• Call an FDA Consumer Complaint Coordinator if you wish to speak directly to a person about your problem.
• Complete an electronic Voluntary MedWatch form online.
• Complete a paper Voluntary MedWatch form that can be mailed to the FDA.

If any parents have questions please contact our experts at hello@byheart.com. For more information visit byheart.comExternal Link Disclaimer or call 1 (833) 429 - 4327