Medium close up of baby boy eating formula while his mother helping him with it

Health Officials Warn of Infant Formula Recall Amid Botulism Outbreak

Published November 12, 2025

SACRAMENTO, Calif. – State and federal health officials are investigating a multi-state outbreak of infant botulism linked to ByHeart Whole Nutrition infant formula, prompting a nationwide recall of all formula products from the company.

In a health advisory released on Tuesday, the California Department of Public Health said that 15 infants with suspected or confirmed cases have been identified since mid-August, including two in California.

All infants had been fed ByHeart Whole Nutrition infant formula and were hospitalized and received treatment. No deaths have been reported.

Early testing by California health officials found Clostridium botulinum spores in samples of ByHeart powdered formula. On Tuesday, the company expanded its recall to include all formula products.

The Centers for Disease Control and Prevention is urging parents and caregivers to stop using any ByHeart Whole Nutrition infant formula immediately. This includes all lot numbers and all cans and single serve packets.

If your infant has consumed ByHeart formula and exhibits poor feeding, loss of head control, difficulty swallowing or decreased facial expression, the CDC recommends seeking immediate medical care.

The CDC also urges parents to stay vigilant, as symptoms may not appear for several weeks after the formula was consumed.

ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide, and the Food and Drug Administration is working to remove affected products from shelves.

According to the FDA, the brand accounts for about 1% of U.S. formula sales, and officials add that the recall will not cause shortages.

CDPH has launched a public hotline to provide information about the outbreak and answer questions. You can call CDPH directly at 1-833-398-2022, seven days a week from 7 a.m. to 11 p.m.