What’s happening

The company ByHeart recently voluntarily recalled all of its baby-formula products sold nationwide in the U.S. amid a rising outbreak of infant botulism.

Originally the recall covered two specific lots, but soon expanded to include all ByHeart products—in stores and homes.

At least 15 infants in 12 states have been hospitalized since August after consuming the brand’s formula.

The outbreak involves a rare illness called Infant botulism (caused by toxin-generating bacteria in the gut of infants under age 1)

Why it matters

• Infant botulism is very rare but very serious, especially for babies whose gut microbiome is still developing. Symptoms may include constipation, weak feeding, drooping eyelids, low muscle tone, difficulty swallowing and breathing problems

What you should do if you might be affected

1. Check your formula
   • If you purchased ByHeart formula, check the brand name, “use by” date, and lot code printed on the bottom of the can or packaging.
   • Even though the full recall covers all products from the brand, ensure you’re not holding any of the specific lots previously identified. U.S. Food and Drug Administration+1
2. Stop use/discard
   • If you have the formula in your home, stop feeding it. Dispose of it safely or return it, according to the company’s instructions and your retailer’s policies.
3. Clean thoroughly
   • Clean any surfaces, feeding bottles, containers, utensils or counters that may have come into contact with the product. The bacterial spores involved can persist in the environment.
4. Monitor the baby
   • If your infant (especially under 1 year old) consumed the recalled product, watch for signs of infant botulism:
     • Constipation or fewer bowel movements
     • Weak feeding or poor appetite
     • Drooping eyelids, weak cry, sluggish response
     • Decreased muscle tone, problems swallowing or breathing
       Symptoms may develop days or even weeks after exposure.
   • If you notice any of these, seek medical care immediately.

What’s next / What we don’t know yet

• The exact cause of the contamination is still under investigation by the U.S. Food & Drug Administration (FDA) and state health agencies. The Washington Post

Key Takeaways for Parents & Caregivers

• This recall is a precautionary measure, but given the vulnerability of infants and severity of the illness, it’s wise to act promptly if you have the affected brand.
• Don’t panic—but do prepare:
  • Verify any formula you have.
  • Ensure safe feeding practices, clean equipment, and proper storage.
  • Know the signs of infant botulism and stay vigilant.
• Maintain supplies: if you need to switch brands, consult your pediatrician to ensure the alternative meets your infant’s nutritional and medical needs.
• Stay informed: regulatory agencies may issue additional updates, guidance or changes.
• Keep communication open: if you are a parent of an infant who was fed the formula, talk with your pediatrician even if the baby appears fine.

Click here to see the letter sent from the By Heart Company and learn more.

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