UPDATE: All ByHeart Whole Nutrition Infant Formula products now recalled because of botulism threat

Update at 3:28 p.m. Nov. 12, 2025: Hawai‘i Department of Health Food and Drug Branch alerts the public that all ByHeart Whole Nutrition Infant Formula products have now been recalled by ByHeart Inc. because of potential contamination with Clostridium botulinum, the bacteria that causes infant botulism.

It’s a rare — but potentially fatal illness — that presents a serious threat to infant health.

The recalled products are under investigation by the U.S. Food and Drug Administration. Parents and caregivers have been warned to stop using all ByHeart products.

The manufacturer recalled all batches of ByHeart Whole Nutrition Infant Formula, including 24-ounce cans and 0.6-ounce individual serve packets.

These infant formula products were available for purchase online and available in Hawai‘i at retailers such as Target and Safeway. Food and Drug Branch officials are working with the local stores to ensure all recalled products are no longer available for sale.

ByHeart Inc. earlier this week initially recalled two batches of its Whole Nutrition Instant Formula after the possible contamination was discovered.

Continue reading below for additional information, including the symptoms of infant botulism and what to do if you have purchased and/or used the recalled product.

Original post at 5 p.m. Nov. 10, 2025: Infant formula issued by ByHeart Inc. has been recalled due to potential contamination with Clostridium botulinum, according to the Hawaiʻi Department of Health’s Food and Drug Branch.

The ByHeart Whole Nutrition Infant Formula product is under investigation by the U.S. Food and Drug Administration (FDA), which has issued a warning to parents and caregivers to stop using certain batches of the formula.

The product was distributed nationwide, including direct-to-consumer sales from the ByHeart website and through Amazon. It was also available locally from retailers like Target, according to the Department of Health.

The Food and Drug Branch is working with local stores to ensure the recalled product is no longer available for sale. This recall currently applies to two batches identified below:

Additional testing of other batches and products from ByHeart Inc. is also being evaluated.

When ingested, Clostridium botulinum spores can colonize in the intestinal tract, leading to infant botulism – a rare, but potentially fatal illness that presents a serious threat to infant health.

Affected infants can present with some or all of the following signs and symptoms:

• Constipation;
• Poor feeding;
• Ptosis (drooping eyelid);
• Sluggish pupils;
• Low muscle tone;
• Difficulty sucking and swallowing;
• Weak or altered cry;
• Generalized weakness;
• Respiratory weakness or difficulty;
• Respiratory arrest.

Contact a healthcare provider immediately if your infant is exhibiting these symptoms after having consumed the recalled product within the last 30 days.

The Food and Drug Branch advises consumers to verify the recalled product by checking the batch code and “best if used by” date printed on the bottom of the can. Consumers who have purchased the recalled product should immediately discontinue use and dispose of it or return it for a refund.

Any utensils, feeding bottles, and other implements should be thoroughly washed with hot, soapy water.

Consumers with questions can contact ByHeart Inc. 24 hours a day, 7 days a week by email at hello@byheart.com, or over the phone at 1-833-429-4327.