Infant Formula Company ByHeart Recalls ByHeart Whole Nutrition Infant Formula Due to Botulism Risk

ByHeart, a baby nutrition company, has recalled two batches of ByHeart Whole Nutrition Infant Formula due to an outbreak of infant botulism. ByHeart formula is carried locally at Whole Foods and Target and is also available online. 

Infant botulism is a rare but potentially fatal illness that presents a serious threat to the health of infants. It occurs when Clostridium botulinum spores are ingested and colonize the intestinal tract of an infant. Affected infants may have some or all of the following 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.

Product Details for Voluntary Recall:

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. See the FDA’s company announcement for product images at the bottom of the page.

Please note: No other ByHeart batches are impacted by this voluntary recall.

What Consumers Should Do:

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.

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 they can contact Byheart at [email protected]. For more information, visit byheart.com or call 1(833) 429-4327 24/7.