A recall for Byheart Whole Nutrition infant formula has been issued by the FDA and CDC due to a nationwide botulism outbreak. The company has voluntarily recalled two lots of the powdered baby formula as part of an ongoing investigation into over a dozen infant botulism cases that have been reported in 10 states. It is suspected that the formula has been contaminated with spores of a bacteria called Clostridium botulinum that “infects a baby’s large intestine and toxin in it,” according to the CDC report.
Botulism outbreak from ByHeart baby formula impacts 13 infants
ByHeart Inc. recalled the following two lots of Whole Nutrition Infant Formula on November 8, 2025:
- 206VABP / 251261P2 – Best Used By Date: 01 Dec 2026
- 206VABP / 251131P2 – Best Used By Date: 01 Dec 2026
The lot numbers and best used by dates can be found on the bottom of the formula container as white text on a blue circular background, as noted in pictures available in the FDA report. It states this product only makes up an estimated 1% of all infant formula in the United States, so this botulism outbreak should not cause shortage concerns for baby formula. The formula is sold in stores nationwide and online.
At the time of writing, there have been 13 reported cases of infant botulism linked to the product across 10 states including Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas, and Washington. It should be noted that the investigation is ongoing and the CDC is conducting laboratory confirmation. The illnesses started on dates from the middle of August to November 2025. Symptoms of infant botulism include loss of head control, difficulty swallowing, poor feeding, and decreased facial expression.
All 13 infants, ranging in age from 16 to 157 days, were hospitalized. No deaths have been reported in connection to this case.
Customers who have purchased the affected product are urged to dispose them or return it to the place of purchase for a full refund. It is recommended that they wash items and surfaces that have come in contact with the recalled formula.
Within the last few weeks, peaches and ready-to-eat pasta have been recalled for potential Listeria bacteria contamination.
