ByHeart
Whole Nutrition
⚠️ Important: ByHeart recalled ALL products in November 2025 after an infant botulism outbreak (48 infants hospitalized, per CDC). As of August 2026, production and sales remain paused with no announced relaunch date. Do not use recalled cans — if you have any at home, discard them and contact your pediatrician with any concerns.
Our verdict
Before November 2025, ByHeart's breast-milk-inspired protein blend (lactoferrin, alpha-lactalbumin, 80:20 whey ratio) made it the most technically ambitious US formula. Then came the recall. Until the company resumes production with the FDA's blessing and rebuilds trust, this page exists to answer questions, not to recommend a purchase — see the alternatives below.
Score breakdown
What's great
- Unique breast-milk-inspired protein blend (alpha-lactalbumin, lactoferrin, hydrolyzed whey) not found in competitors
- Made with organic grass-fed whole milk; lactose-only carbs; palm-oil-free
- Owns its US manufacturing end-to-end (rare among newer formula brands)
Worth knowing
- NOT CURRENTLY FOR SALE: all products recalled November 2025 after an infant botulism outbreak (48 infants hospitalized per CDC); production and sales still paused as of August 2026
- FDA completed facility inspections (announced June 3, 2026) without identifying a root cause; no relaunch date announced
- Company faces lawsuits from families of sickened infants
- Not USDA Organic certified as a finished product despite organic ingredients
What's in it
| Protein | Organic whole milk plus a patented protein blend: alpha-lactalbumin whey protein, partially hydrolyzed (broken-down) whey protein, and lactoferrin; 80:20 whey-to-casein ratio (published, modeled on early breast milk) |
| Carbs | Lactose (no corn syrup, no maltodextrin) |
| Fats | Organic vegetable oils; no palm oil, no soy (no palm oil) |
| Key features | 80:20 whey:casein ratio - highest whey share among these six · Only US infant formula with added lactoferrin plus alpha-lactalbumin · Includes partially hydrolyzed (broken-down) whey proteins · Organic galactooligosaccharides (GOS) prebiotic · No corn syrup, gluten, GMOs, maltodextrin, soy, palm oil, or hexane-extracted DHA · Made with organic, grass-fed whole milk (product itself is not USDA Organic certified) |
| Stage | 0-12 months |
| Forms | powder |
| Where to find it | NONE as of August 2026. Previously DTC subscription at byheart.com ($39/24 oz can) plus retail (Target, Walmart, Kroger, Publix, Albertsons). All unexpired lots recalled November 2025; byheart.com currently sells nothing and states production will resume only in cooperation with the FDA. |
Note: Price shown is the pre-recall DTC price ($39 / 24 oz = $1.63/oz, ~46 four-oz feeds per can) for comparison only. CDC declared the botulism outbreak over February 26, 2026, but state agencies were still finding recalled cans on shelves in March 2026. Any site content must clearly flag the recall and current unavailability.
Best for
What parents say
Recurring themes we found across public parent discussions (https://mommyhood101.com/byheart-infant-formula-review, https://motherhoodcommunity.com/byheart-formula-reviews/, https://www.fda.gov/food/outbreaks-foodborne-illness/outbreak-investigation-infant-botulism-infant-formula-november-2025, https://byheart.com/pages/important-recall-information, https://www.healthbeat.org/2025/12/19/byheart-baby-formula-botulism-outbreak-recall-fda/) — not reviews submitted on this site.
Loved
- Pre-recall: babies transitioning from breastfeeding accepted it readily; parents called it closest to breast milk in smell/taste
- Pre-recall: reports of less colic, gas, and belly pain after switching
- Pre-recall: generally dissolved well
Common complaints
- Foaming when shaken vigorously; some parents waited 30+ minutes for bubbles to subside
- Post-recall: severe loss of trust; the botulism outbreak and hospitalizations dominate all current discussion
- Scattered pre-recall reports of mild constipation or gassiness
Common questions
Why was ByHeart formula recalled?
In November 2025, ByHeart recalled all products after the CDC linked an infant botulism outbreak to its formula, with 48 infants hospitalized. The FDA completed facility inspections in June 2026 without announcing a definitive root cause, and sales remain paused as of August 2026.
Is ByHeart formula available again?
No — as of August 2026, ByHeart sells nothing and says production will resume only in cooperation with the FDA. No relaunch date has been announced.
What are the closest alternatives to ByHeart?
For a premium, palm-oil-free, lactose-only recipe: Bobbie (USDA Organic, US-made) or Kendamil (whole-milk based with MFGM). Neither replicates ByHeart's lactoferrin blend, but both serve the same 'closest to breast milk' intent from ingredient-focused brands.
Reviews from parents like you
Real submissions from readers — moderated for spam, never edited for opinion.
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