November 13, 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.

Related: Tuesday FDA Update: All ByHeart Whole Nutrition Infant Formula Products Have Been Recalled. This Includes All Unexpired Lots Of Formula Cans And Single-Serve “Anywhere” Sticks.

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.

Source: Valley Children's Healthcare, Madera, CA.