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Federal health officials are advising parents and caregivers to stop using specific lots of ByHeart Whole Nutrition Infant Formula due to an ongoing investigation into a multistate outbreak of infant botulism.
The outbreak includes cases in Pennsylvania and nine other states, according to a November 8, 2025, update from the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC).
The company, ByHeart, Inc., has agreed to voluntarily recall two specific lots of the powdered formula that were reportedly consumed by the affected infants:
The lot code and "Use by" date can be found on the bottom of the infant formula can.
Officials report 13 illnesses across 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington. All 13 infants were hospitalized, and there have been no deaths reported at this time.
The FDA recommended the voluntary recall due to the number of illnesses, the severity of the illness, and what officials describe as a strong epidemiological signal linking the formula to the illnesses.
Testing of leftover formula collected in several states is underway, with results expected in the coming weeks. The FDA’s investigation is continuing to try to determine the contamination point and if any other products might be involved.
ByHeart Whole Nutrition Infant Formula is sold both online and at major retailers across the country. However, the manufacturer estimates the affected product makes up less than 1% of all infant formula sold in the United States, meaning this event is not expected to create formula shortage concerns for parents.
Parents and caregivers are advised to throw away any formula from the two recalled lots immediately.
Botulism can be a serious illness. Parents should seek immediate health care if their child ate the ByHeart formula and shows signs of infant botulism, which can take several weeks to appear.
Initial symptoms often include:
These symptoms may progress to difficulty breathing. Physicians who suspect a case of infant botulism are advised to call a 24/7 consultation line at 510-231-7600.