The Short Answer
Throw away any ByHeart formula immediately. Once considered one of the highest-quality premium formulas on the market, ByHeart is currently under a total nationwide recall.
In November 2025, an unprecedented outbreak of infant botulism was linked directly to ByHeart products. As of early 2026, 51 babies have been hospitalized. The FDA has officially confirmed that the Clostridium botulinum bacteria entered the formula through a contaminated batch of organic whole milk powder from one of ByHeart's suppliers.
Why This Matters
Infant botulism is incredibly rare but extremely dangerous. It attacks a baby's nervous system and can cause respiratory failure. Because an infant's digestive tract is immature, it cannot fight off the botulism spores before they release deadly toxins.
This recall shattered the illusion that premium certifications guarantee safety. ByHeart held the prestigious Clean Label Project Purity Award, which tests for heavy metals and pesticides. However, this certification was suspended after the recall because it does not test for deadly biological pathogens like botulism. Heavy Metals Baby Formula
Retailer negligence made the situation worse. Major chains like Target and Walmart received FDA warning letters because they continued selling the recalled formula weeks after the ban. You cannot trust that the formula on your local shelf is safe—you must actively monitor Baby Formula Recalls.
What's Actually In ByHeart Formula
Before the recall, ByHeart was praised for its ingredient profile. Here is what is inside, and where things went wrong:
- Organic Grass-Fed Whole Milk — This provided excellent natural fats for brain development. Tragically, this was the exact ingredient that carried the botulism spores.
- Alpha-Lactalbumin & Lactoferrin — These premium proteins mimic breast milk to aid digestion and immune support. Closest To Breast Milk
- Lactose — ByHeart uses 100% lactose as its carbohydrate, meaning there are zero processed corn syrup solids. Corn Syrup Baby Formula
- Algal Oil DHA — They use a plant-based omega-3 source that is sustainably harvested and extracted without harsh chemical solvents. Hexane Extracted Dha
What to Look For
If you are looking for a replacement for ByHeart, keep these factors in mind.
Green Flags:
- Whole milk fats — Kendamil is an excellent alternative that uses whole milk fat instead of processed vegetable oils.
- Lactose-based — The closest carbohydrate to human breast milk.
- Stringent supplier testing — Look for brands that mandate third-party pathogen testing on raw ingredients before manufacturing. Is Formula Fda Regulated
Red Flags:
- Palm oil — Can cause harder stools and decrease calcium absorption in infants. ByHeart famously avoided this. Palm Oil Baby Formula
- Recalled batches — Never assume a store pulled a recalled item. Always check the lot numbers yourself.
The Best Options
With ByHeart entirely off the market, parents who want premium, European-style nutrition need safe alternatives.
| Brand | Product | Verdict | Why |
|---|---|---|---|
| Bobbie | Organic Infant Formula | ✅ | Spotless safety record and rigorous EU-style recipe. Is Bobbie Good |
| Kendamil | Organic First Infant Milk | ✅ | The best whole milk alternative with zero palm oil. |
| ByHeart | Whole Nutrition Formula | 🚫 | 100% recalled due to life-threatening botulism contamination. |
The Bottom Line
1. Stop using ByHeart immediately. All batches, cans, and travel packs have been recalled.
2. Watch for botulism symptoms. If your baby shows signs of constipation, poor feeding, weak crying, or lethargy, go to the emergency room immediately.
3. Get your refund. ByHeart is offering full refunds for any purchases made since August 2025 through their website or your local retailer.
FAQ
Can I get a refund for my ByHeart formula?
Yes, ByHeart is offering full refunds. If you purchased directly from their website after August 1, 2025, you can contact their customer service. If you purchased at retail, you must return the product to the store for a refund.
Is Bobbie formula safer than ByHeart?
Right now, absolutely. Bobbie has maintained an excellent safety record and uses a rigorous manufacturing process that has never been linked to a pathogen outbreak. Bobbie Vs Byheart
Will ByHeart formula come back?
Eventually, but trust will be hard to rebuild. The company has paused all production to overhaul its supply chain and implement mandatory third-party botulism testing on every single ingredient before it enters their facility.
References (17)
- 1. healthbeat.org
- 2. byheart.com
- 3. healthbeat.org
- 4. aha.org
- 5. pregnantchicken.com
- 6. organiclifestart.com
- 7. govdelivery.com
- 8. byheart.com
- 9. fda.gov
- 10. fda.gov
- 11. byheart.com
- 12. nutritioninsight.com
- 13. prnewswire.com
- 14. healthbeat.org
- 15. byheart.com
- 16. byheart.com
- 17. fredmeyer.com