The Utah Department of Agriculture and Food (UDAF) Division of Regulatory Services is issuing a public health advisory following a voluntary nationwide recall of all ByHeart Whole Nutrition Infant Formula products. This includes all unexpired lots of formula cans and single-serve “anywhere” sticks. The recall was initiated after federal and state investigations identified potential contamination concerns connected to a multi-state outbreak of infant botulism linked to infant formula.
ByHeart Whole Nutrition Infant Formula is sold online and at major retailers nationwide. UDAF is committed to ensuring consumer safety and protecting public health. The Regulatory Services Division has been performing recall audits of Utah retailers to ensure that any recalled products have been removed from stores.
Recall information:
On November 11, 2025, ByHeart Inc. issued a voluntary recall of all ByHeart Whole Nutrition Infant Formula products in collaboration with the U.S. Food and Drug Administration (FDA). This includes:
- All lot numbers
- All sizes of cans and single-serve packets.
FDA Recommendations:
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Parents and Caregivers should stop using any ByHeart infant formula products immediately.
- If your child consumed ByHeart infant formula and is experiencing symptoms (see below) seek immediate medical attention.
- If your child consumed ByHeart infant formula and is not currently showing symptoms, continue monitoring them and seek medical attention if symptoms develop.
- If you still have ByHeart formula in your home, you should:
- Take a photo or record the information on the bottom of the package.
- Keep the container in a safe spot and be sure to label it as DO NOT USE.
- If your child develops symptoms, the Utah Department of Health and Human Services might want to collect your formula container for testing. If your child does not develop symptoms after 30 days, throw your containers out.
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Retailers should ensure recalled products are not on store shelves, including products that have been returned by customers.
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Botulism can be fatal, and you should take action right away. Seek immediate medical attention 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
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If you are a physician and suspect an infant patient has botulism, immediately call the Infant Botulism Treatment and Prevention Program at 510-231-7600 for case consultation. Consultation is available 24/7.
Media Contact: ByHeart Public Relations – [email protected]
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