ByHeart Infant Formula Recalled for Botulism Risk

ByHeart Inc. has issued a voluntary recall of all batches of its Whole Nutrition Infant Formula due to the risk of botulism. This decision follows an investigation into a recent outbreak of infant botulism linked to the formula.

Products Affected:

• ByHeart Whole Nutrition Infant Formula, 24 oz can, UPC: 5004496800
• ByHeart Whole Nutrition Infant Formula, 0.60 oz Anywhere Pack™, 14 packets per package, UPC: 5004496802

The recall affects all batch codes and use-by dates. The products were distributed nationwide in the United States through online and retail channels.

Reason for Recall:

The recall was initiated after Clostridium botulinum, a bacterium that can cause life-threatening illness, was identified in some samples of the formula. Infant botulism is a rare but serious condition that can lead to symptoms such as constipation, poor feeding, drooping eyelids, weak cry, and respiratory difficulties.

What Consumers Should Do:

• Immediately stop using the recalled products.
• Take a photo or record the information on the bottom of the package.
• Label the product as DO NOT USE and keep it in a safe place.
• If your child shows symptoms of botulism, seek medical attention immediately.
• Report any illness or adverse events through the FDA's MedWatch program.

Consumers with questions can contact ByHeart at [email protected] or call 1 (833) 429-4327. The company is available 24/7 to assist.

ByHeart is working closely with the FDA and other health authorities to ensure the safety of its products and is conducting thorough testing with independent laboratories.

As of November 19, 2025, 31 infants have been reported with suspected or confirmed botulism linked to the formula, but no deaths have occurred.