News  DPH Issues Public Health Advisory on Recalled ByHeart Infant Formula Products

The Massachusetts Department of Public Health (DPH) is advising parents, caregivers, clinicians, and local health departments about a nationwide recall of all batches of  ByHeart Whole Nutrition Infant Formula and Anywhere Pack™ products. These products have been voluntarily recalled due to a potential link to infant botulism, a rare but serious illness.

ByHeart formula products were sold online and in retail stores across Massachusetts, including major national retailers. Consumers may still find these products in their homes or listed on online marketplaces. Recalled products should not be used, sold, or purchased.

What is infant botulism?

Infant botulism occurs when spores from the bacteria Clostridium botulinum  are swallowed and begin to grow in an infant’s intestinal tract. The bacteria produce toxins that affect the nervous system and can cause severe illness.

Symptoms can appear slowly and may develop several weeks after an infant drinks the formula.

Infants with botulism may show:

• Hard or no bowel movements (constipation)
• Poor feeding/Not eating well
• Trouble swallowing
• Weak or different sounding cry
• Droopy eyelids
• Loss of head control/Unable to hold head up
• Trouble breathing
• Respiratory arrest (stopping breathing)

If an infant shows any of these symptoms, parents or caregivers should seek emergency medical care immediately.

Infant botulism is diagnosed by a healthcare provider.

Action steps for parents and caregivers

• Seek medical care immediately for infants who drank the formula and have symptoms.
• Do not use ByHeart formula products. Thoroughly wash and sanitize bottles and kitchenware that came into contact with the formula.
• Monitor infants closely over the next several weeks, for infants who drank the product but does not currently have symptoms.
• Save the container, record the lot information, and label it “DO NOT USE.”
• Discard the product, unless otherwise directed by DPH, for infants who do not develop symptoms after 30 days.

Information for retailers

Retailers must ensure:

• All recalled ByHeart formula products are removed from shelves.
• Returned ByHeart formula products are also removed from inventory and not resold.
• Staff are informed about the recall and instructed not to restock affected products.
• Wash and sanitize items and surfaces that may have touched the recalled formula.

Local health departments may conduct recall effectiveness checks and report findings to the DPH Division of Food Protection.

Information for clinicians

Report all suspected cases immediately to DPH by calling 617-983-6800 (24/7) and speaking to the epidemiologist on call. If consultation supports the diagnosis of infant botulism, DPH will assist in obtaining BabyBIG from the California Infant Botulism Treatment and Prevention Program.

For more details about the outbreak and investigation, visit:
Outbreak Investigation of Infant Botulism: Infant Formula | fda.gov

Infant Botulism Outbreak Linked to Infant Formula, November 2025 | cdc.gov

To read the company recall announcement, visit:
ByHeart Broadens Voluntary Recall While Investigation Continues | fda.gov

DPH will continue to share updates as new information becomes available.