The Office of Developmental Programs (ODP) is sharing this important announcement from the PA Department of Health.

As of November 11, 2025, 15 infants with suspected or confirmed infant botulism were reported from 12 states: Arizona, California (2), Illinois (2), Kentucky, Minnesota, New Jersey, North Carolina, Oregon, Pennsylvania, Rhode Island, Texas (2), and Washington. Laboratory confirmation for some cases is ongoing. Illnesses started on dates ranging from mid-August to November 2025. All 15 infants were hospitalized and treated with BabyBIG®. No deaths were reported. Infants ranged in age from 16 to 157 days. State and local public health officials are interviewing caregivers about the foods infants were fed in the month before they got sick. All 15 (100%) reported feeding ByHeart Whole Nutrition infant formula. This investigation is ongoing, and additional cases may be identified.

All ByHeart Whole Nutrition Infant Formula products were recalled. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks. The link to the recall can be found here.

According to the FDA, ByHeart Whole Nutrition Infant Formula makes up less than 1 percent of all infant formula sales in the United States. Given this small market share, recall of these products is unlikely to create shortage concerns of infant formula for parents and caregivers.

Summary:

• On November 11, 2025, ByHeart, Inc. recalled all lots of ByHeart Whole Nutrition Infant Formula in response to the U.S. Food and Drug Administration’s (FDA’s) ongoing investigation into a recent outbreak of infant botulism.
• According to the company’s website, ByHeart Whole Nutrition Infant Formula was sold through its website ByHeart.com and through retail stores nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, SamsClub, and others.
• Infant botulism is a rare but potentially fatal paralytic illness that impacts babies less than one year old. Symptoms can include constipation, poor feeding, drooping eyelids, weak cry, and progressive muscle weakness.
• Health care providers (HCP) should call the California Infant Botulism Treatment and Prevention Program (IBTPP) immediately at 510-231-7600 for consultation of suspected case. Consultation is available 24/7. Treatment with botulism immune globulin, BabyBIG®, obtained from California Department of Health, is recommended for all suspected cases of infant botulism.
• Infant botulism is a reportable disease in PA; all suspected cases must be reported to the Pennsylvania Department of Health (DOH) at 1-877-PA-HEALTH or their local health department.

For More Information

• Federal Drug Administration (FDA): ByHeart Broadens Voluntary Recall While Investigation Continues
• Centers for Disease Control (CDC): Investigation Update: Infant Botulism Outbreak November 2025
• CDC: Clinical Guidelines for Diagnosis and Treatment of Botulism, 2021
• FDA: In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula
• FDA: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025)