The FDA, CDC, and state health agencies are investigating a multistate outbreak of infant botulism linked to ByHeart Whole Nutrition Infant Formula. The outbreak has prompted a nationwide recall of all unexpired lots, including standard cans and single-serve “Anywhere Sticks.” Fifteen infants from twelve states have been hospitalized with confirmed or suspected botulism after consuming the formula; no deaths have been reported. Illness onsets range from August 9 to November 10, and preliminary testing by the California Department of Public Health found evidence of bacteria capable of producing botulinum toxin in an opened can from lot 206VABP/251131P2 that had been fed to one of the affected infants.

ByHeart products account for less than 1 percent of U.S. formula sales, yet more than 40 percent of cases in this period involved infants who consumed the brand. The FDA cautions that testing powdered formula for botulinum-producing bacteria is complex and that negative results do not rule out contamination. The investigation is ongoing as federal and state partners work to pinpoint the source.

Parents and caregivers are urged to stop using ByHeart formula immediately. Caregivers of infants who consumed the product should monitor for symptoms such as constipation, loss of head control, trouble swallowing, or breathing difficulties, and should seek immediate medical care if symptoms appear. Caregivers are advised to photograph and save any remaining formula—clearly marked “Do Not Use”—for 30 days in case health officials request testing.

While no cases have been reported in Wisconsin yet, the recall affects national distribution. Local families who purchased ByHeart formula should check their products carefully and contact retailers regarding returns or disposal.

For more information, visit www.fda.gov.