ByHeart Expands Baby Formula Recall Amid Infant Botulism Investigation

Parents across the country are on high alert after ByHeart significantly expanded its baby formula recall, following an ongoing investigation into a case of infant botulism potentially linked to the company’s powdered formula. The FDA, CDC, and now major news outlets — including the Associated Press through ABC News — have all confirmed new details as the investigation unfolds.

This consumer-safety update provides the latest information from the FDA, the expanding recall, the new reporting from ABC News, and essential steps parents should take to keep their children safe. As always, Ketterer, Browne & Davani (KBD) Attorneys is closely monitoring these developments to ensure families get the answers and legal support they deserve.

What We Know About the ByHeart Recall

ByHeart widened its initial voluntary recall after a baby developed infant botulism, a rare but extremely dangerous illness caused by toxins produced by Clostridium botulinum. According to the FDA, both opened and unopened cans of ByHeart Whole Nutrition Infant Formula were tested, though no contamination has yet been confirmed in the product itself.

ByHeart has recalled multiple lots of its powdered formula “out of an abundance of caution,” including products produced between March and June 2023, with expiration dates extending into 2025.

The key takeaway:
Even without confirmed contamination, the FDA and CDC emphasize that parents should immediately stop using any recalled lots and follow all safety instructions issued by ByHeart.

ABC News: Recall Now Considered Nationwide

The new reporting from ABC News / Associated Press strengthens the public safety message:

• The recall now affects formulas sold nationwide, not limited to regional distribution.
• ByHeart says the recall is proactive, but the CDC is continuing to evaluate any connection between the illness and the formula.
• This case marks one of the rare instances where infant botulism is being investigated in connection with a commercial powdered formula.

This added confirmation from national news outlets validates the seriousness of the recall and provides more independent visibility into FDA and CDC actions.

What Is Infant Botulism? Why Are Experts Concerned?

Infant botulism occurs when spores of C. botulinum grow inside a baby’s intestines, producing toxins that block nerve function. Powdered formula can be a potential risk factor if contaminated, because it is not sterile.

Symptoms include:

• Weak suck or poor feeding

• Constipation

• Lethargy

• Weak cry

• Muscle weakness or “floppiness”

Infant botulism is rare, but it very dangerous. It requires immediate hospital treatment and can be life-threatening.

Parents: What To Do Right Now

To protect your child:

1. Check your ByHeart formula cans immediately

Compare your lot number to the recall list available on the FDA’s website and ByHeart’s recall page.

2. Stop using any recalled formula

Do not try to “use up” the can — discard it or follow ByHeart’s refund/replacement process.

3. Watch for symptoms

If your child shows signs of infant botulism, seek medical attention immediately.

4. Report any illness or adverse reaction

You can file a report with both:

• FDA’s MedWatch

• CDC’s reporting system (your pediatrician or hospital can also assist)

Where This Investigation Stands

The FDA has confirmed that multiple samples from the affected household — including opened and unopened formula containers — are being tested. So far, no direct contamination has been identified in the ByHeart product itself.

However, because infant botulism is so rare and the potential consequences are severe, regulators and researchers are pursuing a full investigation, and ByHeart has chosen to act conservatively by expanding its recall.

KBD Attorneys: Protecting Families When Baby Products Cause Harm

Ketterer, Browne & Davani, LLC, represents families nationwide in baby-product injury cases, including:

• Contaminated or defective formula

• Unsafe baby products sold on Amazon

• Heavy metal exposure in baby foods

• Infant product recalls involving suffocation, choking, or toxic exposure

• Manufacturers and distributors who fail to warn about known dangers

KBD has published extensive consumer-safety resources about:

• Infant formula recalls

• Heavy metal baby food litigation

• Amazon product liability

• Baby product safety hazards (high chairs, magnets, bassinets, etc.)

If your child became ill after using ByHeart formula — or if you still have recalled formula in your home — our attorneys are available to review the facts, answer questions, and advise you on your legal rights.

We Are Here to Help

No parent should have to guess whether their baby’s formula is safe. KBD is committed to helping families navigate recalls, understand legal options, and hold negligent corporations accountable.

If you have concerns about this recall or believe your child may have been affected, contact KBD Attorneys for a free case review.