ByHeart

Reference coverage. ByHeart isn't sold by Organic's Best. We cover it because it's the most scientifically ambitious new US formula, the first to include 5 HMOs, and a common comparison point for parents weighing European organic options against premium US alternatives. Honest editorial, no commercial funnel.

⚠ URGENT: Active recall (November 2025, ongoing)

All ByHeart Whole Nutrition Infant Formula products are under voluntary recall due to a multistate infant botulism outbreak. The FDA investigation began in November 2025 and expanded on November 11, 2025 to cover every batch ever produced.

Key facts as of January 2026:

• 51 infants hospitalized across 19 states since December 2023.
• Clostridium botulinum Type A detected in sampled organic whole milk powder and confirmed as a genetic match to Type A found in finished ByHeart product.
• No deaths reported to date; all hospitalized infants have received treatment.
• Recall scope: all ByHeart cans and Anywhere Packs nationwide.
• FDA warning letters have been issued to retailers found still stocking recalled product weeks after the recall was announced.

If you have ByHeart formula in your home: stop using it and return or discard per the FDA recall notice. Contact your pediatrician if your baby has shown any symptoms of botulism (constipation, weak cry, poor feeding, drooping eyelids, muscle weakness).

This is the largest and most systemic US infant formula recall since the 2022 Abbott/Similac Cronobacter event, and because the implicated ingredient (organic whole milk powder) is a specific contamination source rather than a general manufacturing hygiene issue, the remediation may affect ByHeart's ability to resupply the market for months.

See the full timeline of this recall in the Infant Formula Atlas changelog as we track ongoing developments.

ByHeart is the most research-heavy US infant formula launch of the last decade. Co-founded in 2016 by brothers Ron and Mia Funes-Belldegrun, the brand spent six years building its own manufacturing capability, a rarity among startup formulas, and launched its first product in 2022 under the name "ByHeart Whole Nutrition Infant Formula." The timing was coincidental but fortunate: the Abbott/Similac Cronobacter recall opened the US market to new entrants just as ByHeart reached distribution scale. By 2024, ByHeart was one of the five largest US infant formula brands by new-customer acquisition.

The value proposition is distinctive: whole-protein formulation (rather than whey-casein separation), organic grass-fed whole milk as the protein base, and a prebiotic stack that includes 5 different HMOs, more than any competitor.

The founding story

Ron Belldegrun's background is pharma finance; his sister Mia's is biotech research. They built ByHeart in response to what they saw as a structural gap in the US market: every major US formula used separated casein/whey protein processing, which they argued didn't match the intact-protein structure of breast milk. The alternative, using whole milk directly as the protein base, requires different manufacturing equipment than standard whey-based production, which is why ByHeart built its own facility rather than contracting with Perrigo or the other common US co-manufacturers.

The R&D investment was substantial: ByHeart's published research includes at least 4 clinical trials (growth study, stool consistency, tolerance, 5-HMO safety). Few formulas have this volume of their own clinical documentation.

What's unique about ByHeart

• Whole-protein approach. ByHeart uses organic whole milk as the primary protein source rather than the skim milk and separated whey powder used by most US and European formulas. Proteins are less processed; the 60:40 whey:casein ratio comes from the natural ratio in the milk plus added alpha-lactalbumin, not from industrial recombination.
• 5 HMOs, the most in any US formula. 2'-FL, 3-FL, LNT, 3-SL, 6-SL. See our 2'-FL HMO explainer for context. Most HMO-fortified formulas include only 2'-FL; ByHeart's 5-HMO blend more closely approximates the HMO diversity of breast milk.
• Lactoferrin. One of the few US brands to include lactoferrin alongside HMOs.
• FDA-registered US infant formula. Full 21 CFR 107 compliance from a domestic manufacturing facility.
• Organic grass-fed milk: Certified USDA Organic, grass-fed dairy sourcing.

Not organic-certified across the whole product (the broader formula is not labeled USDA Organic; only the milk portion is). ByHeart is transparent about this on its ingredient list.

Comparison vs Bobbie and European options

For parents comparing ByHeart against alternatives:

• vs Bobbie. Bobbie is USDA Organic across the whole formula; ByHeart is not. Bobbie uses standard skim-milk-based protein; ByHeart uses whole milk. Both are FDA-registered. ByHeart has the 5-HMO stack and lactoferrin; Bobbie does not include HMOs or lactoferrin. Different positioning: Bobbie is "EU-style compositon at US retail"; ByHeart is "maximum bioactive ingredient depth at US retail."
• vs HiPP Dutch. HiPP's prebiotic is GOS alone (no HMOs); HiPP has Metafolin and a live probiotic strain. ByHeart has richer HMOs and lactoferrin but no live probiotics and no Metafolin. Different axes of optimization.
• vs Kendamil. Kendamil also uses whole milk fat; neither has HMOs. Kendamil has broader SKU range and lower price point per ounce.

Our Infant Formula Atlas lets you compare ByHeart directly against these alternatives on every attribute.

Certifications and regulatory posture

• FDA-registered under 21 CFR Part 107. Fully domestic, no enforcement-discretion caveat.
• Clean Label Project Purity Award, third-party testing for 400 and contaminants.
• Non-GMO Project Verified, the leading US non-GMO standard.
• USDA Organic applied to the milk specifically (not the whole formula).

The partial organic certification is worth flagging: ByHeart uses organic milk but adds non-organic micronutrients and processing aids. This is common in specialty formulas but different from Bobbie's fully-organic positioning. Not a quality issue; a positioning choice.

Recall history

ByHeart has had two recall events in its short operating history:

• December 2022 voluntary recall of a limited number of batches due to Cronobacter sakazakii concerns. A small number of lots tested positive; no infant illnesses linked to the recalled product. Response at the time was viewed as transparent and appropriate.
• November 2025 voluntary recall of ALL products (see the urgent notice at the top of this page). Linked to a multistate infant botulism outbreak involving Clostridium botulinum Type A traced to the organic whole milk powder used as ByHeart's protein base. 51 hospitalizations across 19 states as of January 2026.

The 2025 recall is a significant event that materially changes how we evaluate ByHeart as a brand recommendation. The company's response and transparency have been reasonable, but the scope, every batch ever produced, 51 hospitalizations, is unprecedented for a US infant formula startup and raises structural questions about the whole-milk-powder supply chain that ByHeart built as a differentiator.

My take on ByHeart for parents (post-2025-recall)

Before the November 2025 botulism recall, ByHeart was the US formula I would have recommended for parents prioritizing HMO content and bioactive-ingredient depth. The 5-HMO blend plus lactoferrin plus whole-milk protein approach remains the most ambitious US formulation on paper.

The 2025 recall changes the current recommendation. Until ByHeart restocks with demonstrably clean supply, and until the FDA investigation of the organic whole milk powder supply chain resolves, a parent choosing now should look to other options. The risk is not hypothetical, 51 infants have been hospitalized.

For parents who want ByHeart's formulation approach after the recall resolves, the expectation is that remediation, requalification, and returning to shelves will take months at minimum. In the interim:

• For "closest to breast milk at US retail," Bobbie is the cleanest alternative. USDA Organic, FDA-registered, simpler formulation.
• For broader bioactive depth (HMOs), Similac Pro-Advance or Enfamil Enspire include single HMOs (2'-FL) and are widely available.
• For European-style formulation, HiPP Dutch, Holle, and Kendamil via Organic's Best Shop remain unaffected by this recall.

We will update this page as the FDA investigation progresses and ByHeart's remediation timeline becomes clear.

All ByHeart formulas

ByHeart currently sells a single formula (Whole Nutrition), suitable for 0-12 months. Phase II adds the full SKU with complete nutrition panel.

FAQ

Sources

• ByHeart corporate: https://www.byheart.com/
• FDA infant formula registration: https://www.fda.gov/food/infant-formula-guidance-documents-regulatory-information
• Clean Label Project: https://www.cleanlabelproject.org/
• FDA recall notice (December 2022): https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
• ByHeart published research (growth study): https://pubmed.ncbi.nlm.nih.gov/36421987/

Related reading

• Head-to-head comparisons, Bobbie Original vs ByHeart Whole Nutrition (USDA Organic premium vs recalled bioactive-rich), ByHeart Whole Nutrition vs HiPP Dutch Stage 1 (EU Combiotik alternative), ByHeart Whole Nutrition vs Kendamil Classic Stage 1, ByHeart Whole Nutrition vs Kendamil Organic Stage 1 (the closest whole-milk-fat, palm-free, and EU Organic replacement), and ByHeart Whole Nutrition vs Earth's Best Dairy (premium bioactive recalled vs budget WIC-eligible active)
• US formula recall history (2025 ByHeart Class I nationwide recall in context)
• FDA 21 CFR 107 explained
• How formula brands compare, buyer framework

This site provides research and comparisons, not medical advice. Consult your pediatrician before changing your baby's formula.