MONTGOMERY, Ala. – Alabama Department of Agriculture and Industries (ADAI) food safety inspectors are conducting recall effectiveness checks on all batches of ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ nationwide as they may be contaminated and are making infants sick with infant botulism.
“ADAI is working closely with the Alabama Department of Public Health, CDC and FDA to be sure all remaining products are removed from store shelves,” said Agriculture and Industries Commissioner Rick Pate. “The health and safety of children is our top priority.”
After inspecting a total of 93 stores, ADAI food safety inspectors have collected 57 products from 10 separate locations.
Parents and caregivers have reported feeding infants in this outbreak different lots of ByHeart infant formula that were not included in the company's original recall on November 8, 2025. On November 11, 2025, ByHeart Inc. recalled all ByHeart Whole Nutrition infant formula products.
Parents and caregivers are urged to stop using any ByHeart Whole Nutrition infant formula immediately. This includes all lot numbers and all sizes of cans and single serve packets. ByHeart Whole Nutrition Infant Formula is available for sale online and at major retailers nationwide.
Infant botulism is a rare but serious illness that occurs when Clostridium botulinum spores are ingested and then colonize the intestinal tract, producing botulinum neurotoxins in the immature gut of infants. Affected infants can present with some or all of the following signs and symptoms: constipation, poor feeding, ptosis (drooping eyelid), sluggish pupils, low muscle tone, difficulty sucking and swallowing, weak or altered cry, generalized weakness, respiratory difficulty, and possible respiratory arrest. If your child is experiencing any of these symptoms, please seek medical attention immediately.
The FDA and CDC have been conducting a broader investigation into a spike of 84 infant botulism cases that started in August. Once ByHeart was alerted on November 7, 2025, the company acted decisively. The results of the FDA’s investigation into the broader cases will help inform any additional steps as the investigation continues.
Consumers who have purchased ByHeart Whole Nutrition Infant Formula cans and Anywhere Pack™ should immediately discontinue use and return the product to the point of purchase. If your infant is experiencing symptoms related to infant botulism, contact your health care provider immediately.
To report an illness or adverse event, call an FDA Consumer Complaint Coordinator by visiting FDA’s SmartHub webpage, which will guide consumers to the appropriate webform or phone number.
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