K A S H R U T . C O M_©

November 8, 2025 – from the FDA

Product: Certain lots of ByHeart Whole Nutrition Infant Formula:

• Lot: 206VABP/251261P2 (“Use by 01 Dec 2026”)
• Lot: 206VABP/251131P2 (“Use by 01 Dec 2026”)

ByHeart Whole Nutrition Infant Formula makes up an estimated less than 1% of all infant formula sold in the United States and this outbreak does not create shortage concerns of infant formula for parents and caregivers.

Stores affected" ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.

The FDA and CDC, in collaboration with California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of 13 infant botulism illnesses from 10 states: Arizona, California (2), Illinois (2), Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas (2), Washington. Laboratory confirmation for some cases is ongoing.

Recommendation

• Parents and Caregivers should not use certain lots of ByHeart Whole Nutrition Infant Formula and should throw this product away immediately. If your child is experiencing symptoms (see below) after consuming ByHeart Whole Nutrition Infant Formula and you still have the formula in your home, please record the information on the bottom of the package before throwing it away.
• Botulism can be fatal, and you should take action right away. If your child has consumed ByHeart Whole Nutrition Infant Formula and is experiencing signs and symptoms of botulism such as poor feeding, loss of head control, difficulty swallowing, or decreased facial expression, seek immediate health care.
• If you are a Physician and suspect your infant patient has botulism, immediately call 510-231-7600 for case consultation. Consultation is available 24/7.