Over the past week, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have launched an urgent investigation into a nationwide outbreak of infant botulism, a rare but potentially life-threatening condition that has been linked to baby formula produced by ByHeart. As part of this investigation, ByHeart has recalled all of its Whole Nutrition Infant Formula products sold in the United States, effective November 11, 2025.
At CD Law, protecting families isn’t just part of our work, it’s deeply personal. As fathers themselves, partners Vineet Dubey and Miguel Custodio know the fear that comes with trusting products meant to nourish our children. And as a firm that has advocated tirelessly for families affected by lead-tainted baby food, news of the recent ByHeart formula recall hits especially close to home.
Click HERE to visit our Instagram page to hear from Vineet about the recall.
What’s Happening?
The FDA notified ByHeart on November 7, 2025, that at least 83 cases of infant botulism had been reported since August 2025. Many infants involved in the outbreak were confirmed to have consumed ByHeart formula leading the investigation to believe the formula could be contaminated. The CDC has now identified cases across 13 states, including 23 hospitalizations.
Infant botulism occurs when babies ingest Clostridium botulinum spores, which produce dangerous toxins in the stomach. While rare, it can be fatal if not caught early.
Signs and Symptoms of Infant Botulism
Seek immediate medical care if your baby consumed ByHeart formula and shows any of the following symptoms. Symptoms can take several weeks to develop.
- Poor feeding
- Constipation
- Weak or altered cry
- Difficulty sucking or swallowing
- Loss of head control
- Drooping eyelids
- Decreased facial expression
- General weakness
- Respiratory issues
What Products Are Included in the Recall?
All ByHeart Whole Nutrition Infant Formula is being recalled.
This includes:
- All lot numbers
- All sizes of cans
- All single-serve packets
- Formula sold both online and at major retailers nationwide
What Should Parents Do Right Now?
If you have any ByHeart formula in your home, the FDA and CDC advise that you stop using it immediately. The FDA and CDC have recommended the following:
1. Do NOT use any ByHeart Whole Nutrition Infant Formula.
If you have been feeding your child ByHeart’s formula, photograph or write down the lot number and “best by” date.
2. Keep leftover formula safely stored.
Label it “DO NOT USE” and store it for at least 30 days. If your baby shows symptoms of botulism, public health officials may need the product for testing.
If no symptoms appear after a month, throw it away.
CD Law Can Help
We stand with families navigating this frightening and frustrating situation and will continue to fight for stronger protections for infants and children.
Vineet Dubey of CD Law says,”No parent should ever have to worry that the formula they trusted could harm their child. This recall is frightening, but it underscores why we must keep fighting for rigorous testing and uncompromising safety standards for the entire baby food and formula industry. Our babies rely on us, and we’ll continue holding companies accountable when they fail them.”
If you or someone you know has been affected by this recall, please reach out. We’re here to help families understand their rights and investigate potential claims.
Your family’s safety is our priority!
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December 08, 2025