Health officials are urging caregivers to stop using specific batches of ByHeart Whole Nutrition Infant Formula after a rise in reported cases of infant botulism linked to the product.
The Food and Drug Administration announced that certain lots of ByHeart Whole Nutrition Infant Formula should not be used while investigations continue. Since August, at least 13 infants in 10 states have developed botulism type A infections after consuming the formula. No deaths have been reported, but all cases required hospitalization.
ByHeart said in a statement that it has initiated a voluntary recall “out of an abundance of caution,” emphasizing that no botulism spores or toxins have been confirmed in the formula so far. The company noted that the recalled lots represent less than 1 percent of all infant formula sold in the United States and that the recall should not lead to shortages.
What ByHeart Infant Formula Products Are Under Recall?
ByHeart Whole Nutrition Infant Formula
Affected Lots:
- Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”)
- Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)
The lot code and “Use by” date are located on the bottom of the can. ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.
FDA and CDC Investigation Update
The FDA and CDC, in collaboration with the California Department of Public Health, Infant Botulism Treatment and Prevention Program (IBTPP), and other state and local partners, are investigating a multistate outbreak of 13 infant botulism illnesses in 10 states.
Laboratory testing is underway to confirm contamination and identify the point of origin. Results are expected in the coming weeks. The FDA has recommended a voluntary recall due to the severity of illness and strong epidemiological links to the ByHeart formula. The agency continues to work with the company to ensure that all potentially affected products are removed from the market.
Recommendation for Parents and Caregivers
Parents and caregivers should not use these specific lots of ByHeart Whole Nutrition Infant Formula and should throw the product away immediately.
If your child has consumed this formula and is showing signs of botulism—such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression—seek immediate medical care.
If you still have the formula at home, record the lot information on the bottom of the can before disposing of it.
Physicians can also seek help by calling 510-231-7600 for consultation with the Infant Botulism Treatment and Prevention Program (available 24/7).
What Parents Should Know About Botulism
Botulism is a rare but serious illness caused by a toxin that attacks the body’s nerves and can lead to paralysis. In infants, it typically occurs when spores of the bacterium Clostridium botulinum grow and produce toxins in the intestines.
Early detection and treatment are crucial. With prompt medical care, most infants recover fully.
Symptoms of Infant Botulism
Infant botulism can be fatal if untreated. Common early signs include:
- Constipation
- Poor feeding
- Loss of head control
- Difficulty swallowing or breathing
- Decreased facial expression
Symptoms can take several weeks to appear after ingestion of contaminated formula, and prompt medical care is critical to treating botulism.
Current Outbreak Details
The outbreak involves 13 confirmed illnesses across the following 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington.
All affected infants were hospitalized; no deaths have been reported. Officials in several states have collected leftover formula samples for testing.
FDA testing and traceback efforts are ongoing. Updates will be posted on the FDA’s outbreak investigation page as new information becomes available.
Case Count Summary For Concerned Parents
- Total Illnesses: 13
- Hospitalizations: 13
- Deaths: 0
- Last Illness Onset: November 2025
- States with Cases: AZ, CA, IL, MN, NJ, OR, PA, RI, TX, WA
- Product Distribution: Online and nationwide
While I’ve listed some of the primary symptoms of botulism, note that other side effects may occur. If your child has consumed ByHeart Whole Nutrition Infant Formula products listed in the recall, keep an eye on their general health over the next several weeks.