FDA Recall 2025: ByHeart Infant Formula Pulled Nationwide for Botulism Risk

Key takeaway: The FDA has announced a nation-wide recall of every batch of ByHeart Whole Nutrition Infant Formula and ByHeart Anywhere Pack™ after an investigation uncovered potential Clostridium botulinum contamination. Parents and caregivers should immediately stop use, check the UPCs listed below, and safely discard any product on hand.

Recalled ByHeart Infant Formula Products

• ByHeart Whole Nutrition Infant Formula — 24 oz can (UPC 85004496800)
• ByHeart Anywhere Pack™ — 0.6 oz packets, 14-count box (UPC 85004496802)
• All production dates and lot codes are included in the recall.

Official Recall Sources

• FDA Recall Notice
• FDA Outbreak Advisory

Why This Recall Matters

Since August 2025, the FDA and CDC have documented 84 confirmed cases of infant botulism. While no unopened ByHeart formula has tested positive, the company chose to broaden its voluntary recall “out of an abundance of caution.” Botulism in infants can lead to constipation, weak cry, poor feeding, muscle weakness, breathing difficulties, and—if untreated—respiratory failure.

Immediate Actions for Parents and Caregivers

1. Stop feeding any ByHeart formula products to your baby.
2. Discard the product in a sealed plastic bag so it cannot be used again.
3. If your child shows possible botulism symptoms, seek emergency medical care.
4. Contact ByHeart at 1-833-429-4327 or hello@byheart.com for a full refund.
5. Report adverse reactions to the FDA through the online MedWatch form, by contacting an FDA Consumer Complaint Coordinator, or by mailing the paper MedWatch form (PDF).

Company Response & Ongoing Investigation

ByHeart is working with the FDA, the California Department of Public Health, and independent laboratories to:

• Remove all recalled formula from retail and online marketplaces.
• Test every production batch with third-party labs.
• Provide regulators with full, on-site access to manufacturing facilities.
• Publish all lab results once validated.

The recall will remain in place until investigators confirm the source of contamination and verify product safety.

Recall Images

ByHeart Recall FAQ

Why was ByHeart infant formula recalled?

The FDA found potential contamination with Clostridium botulinum, the bacterium that causes botulism. ByHeart expanded its voluntary recall to include all batches until safety can be verified.

Which ByHeart UPC codes and lot numbers are affected?

Every lot is under recall:

• ByHeart Whole Nutrition 24 oz can — UPC 85004496800
• ByHeart Anywhere Pack™ 14-count box — UPC 85004496802

What symptoms of infant botulism can appear after using ByHeart formula?

Watch for constipation, poor feeding, drooping eyelids, weak cry, reduced muscle tone, difficulty swallowing, or breathing problems. Seek medical care right away if any symptom develops.

How do I get a refund or replacement from ByHeart?

Call ByHeart’s 24/7 support line at 1-833-429-4327 or email hello@byheart.com. Customer-care agents will guide you through the refund process.

Is any unopened ByHeart infant formula safe to use?

No. The recall covers all unopened and opened ByHeart formula currently in circulation.

How should I dispose of recalled ByHeart formula?

Seal the product in a plastic bag, place it in household trash, and keep it away from children and pets. Do not donate or feed it to animals.

Can I switch brands immediately if my ByHeart supply is recalled?

Yes. Consult your pediatrician to choose an alternative formula that meets your baby’s nutritional needs while ByHeart products remain off the market.