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WV Health Alerts Parents to ByHeart Infant Formula Recall

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Published November 10th, 2025
Detected March 17th, 2026
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Summary

The West Virginia Department of Health is alerting parents and caregivers to a voluntary recall of certain lots of ByHeart powdered infant formula due to a multistate outbreak of infant botulism. The recall was announced by the FDA on November 8, 2025, with 13 cases reported across 10 states.

What changed

The West Virginia Department of Health (DH) has issued an alert to parents and caregivers regarding a voluntary recall of specific lots of ByHeart powdered infant formula. This recall follows a multistate outbreak of infant botulism, with 13 cases reported across 10 states as of November 8, 2025. While no cases have been confirmed in West Virginia, the DH is increasing surveillance activities.

Parents and caregivers are advised to immediately stop using any recalled ByHeart powdered formula. They should consult the FDA recall webpage for information on affected lot numbers, safe disposal instructions, and how to request a replacement product. The DH also reminds consumers that infant botulism is a serious illness, and they should seek immediate medical care if an infant exhibits symptoms such as constipation, poor feeding, weak cry, drooping eyelids, or muscle weakness.

What to do next

  1. Review ByHeart powdered infant formula lot numbers for affected products.
  2. Discontinue use of recalled formula immediately.
  3. Follow FDA guidance for safe disposal and replacement of recalled formula.

Source document (simplified)

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Search this site WVDHHR > News > West Virginia Department of Health Alerts Parents and Caregivers to Recall of ByHeart Powdered Infant Formula

West Virginia Department of Health Alerts Parents and Caregivers to Recall of ByHeart Powdered Infant Formula

11/10/2025

​The West Virginia Department of Health (DH), Bureau for Public Health, Office of Epidemiology and Prevention Services, is alerting parents and caregivers that ByHeart has voluntarily recalled certain lots of its powdered infant formula following a multistate outbreak of infant botulism. The recall was announced by the U.S. Food and Drug Administration (FDA) on Saturday, November 8, 2025.

To date, 13 cases have been reported across 10 states. No confirmed cases have been identified in West Virginia; however, DH is enhancing surveillance activities statewide.
“Protecting the health of West Virginia infants and families is our highest priority,” said Dr. Mark McDaniel, Acting State Health Officer. “Parents and caregivers should immediately stop using any recalled ByHeart powdered formula and follow FDA guidance for checking lot numbers, safely disposing of the product, and requesting a replacement.”
Infant botulism is a rare but serious illness caused by Clostridium botulinum spores. Symptoms can include constipation, poor feeding, weak cry, drooping eyelids, and muscle weakness. Parents should seek medical care immediately if an infant shows any signs of illness.
Consumers can find information on affected lots and disposal instructions on the FDA recall webpage.
For more information about infant botulism, visit the CDC Botulism webpage.

Contact Information

dhcommunications@wv.gov Contact Us | Site Map
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Source

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Classification

Agency
State Health
Published
November 10th, 2025
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Substantive

Who this affects

Applies to
Consumers Healthcare providers
Geographic scope
State (West Virginia)

Taxonomy

Primary area
Public Health
Operational domain
Compliance
Topics
Food Safety Product Recalls

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