⚠ Important: ByHeart is under active nationwide Class I recall
All ByHeart Whole Nutrition Infant Formula products remain under Class I nationwide recall initiated November 2025 following a multistate infant botulism outbreak (Clostridium botulinum Type A, 51 hospitalizations across 19 states, traced to organic whole milk powder in ByHeart's supply chain). Every batch ever produced is recalled. Do not purchase ByHeart from any source until FDA-cleared resupply.
For families comparing ByHeart against Earth's Best, the practical decision is now: Earth's Best is active-supply, WIC-eligible in several states, and at the opposite extreme of the US organic price spectrum. ByHeart's bioactive-depth advantage is moot until supply resumes.
ByHeart Whole Nutrition (recalled) was FDA-registered, whole-milk fat, and palm-free and 2'-FL HMO, lactoferrin, and GOS at ~$1.88/oz pre-recall. Earth's Best Organic Dairy is USDA Organic, FDA-registered, and FOS prebiotic at ~$1.29/oz, palm and soy in its vegetable oil blend. With ByHeart recalled, Earth's Best is the active-supply choice, especially for WIC-eligible families in states where Earth's Best is covered.
Why this comparison matters
These two SKUs sit at opposite extremes of the US organic price spectrum: ByHeart was the bioactive-rich premium flagship (pre- recall), Earth's Best is the long-running supermarket-tier budget option. Parents comparing them typically have very different budget realities (ByHeart's ~$1.88/oz was premium; Earth's Best's ~$1.29/oz is the cheapest USDA Organic available). With ByHeart recalled, the comparison shifts from "which is better" to "what Earth's Best delivers, and how it differs from what ByHeart offered."
At a glance
| Dimension | ByHeart Whole Nutrition | Earth's Best Organic Dairy |
|---|---|---|
| Status | RECALLED NATIONWIDE (Nov 2025), do not purchase | Active supply |
| Manufacturer | ByHeart (US, own facility) | Hain Celestial Group (US) |
| Origin | USA | USA |
| Age range | 0-12 months | 0-12 months |
| Regulation | FDA 21 CFR 107 | FDA 21 CFR 107 |
| Organic certification | Clean Label Project Purity Award and Non-GMO Project (NOT USDA Organic) | USDA Organic and Non-GMO Project Verified |
| Protein | Whole cow milk and whey | Skimmed cow milk and whey |
| Whey:casein | 80:20 (closer to breast milk) | 60:40 |
| Primary carbohydrate | Lactose (only added) | Lactose (primary) |
| Prebiotic | GOS | FOS |
| Probiotic | None | None |
| HMO | 2'-FL HMO | None |
| Lactoferrin | Yes | None |
| Folate form | Folic acid | Folic acid |
| DHA source | Algal oil, ~13.4 mg/100 ml | Algal oil, ~11 mg/100 ml |
| Fat blend | Whole-milk fat and sunflower/rapeseed/coconut (no palm) | Palm olein, soybean oil, coconut, and safflower |
| Fat-blend notes | None pre-recall | Palm oil, soy |
| Recall history | 2022 Cronobacter and 2025 Botulism (active nationwide Class I) | None |
| WIC eligibility | Not covered anywhere | Covered in several US states |
| Typical price | ||
| US availability | Currently NONE, recalled | Broad US retail (Whole Foods, Target, Walmart, Kroger, Amazon) |
Visual generated with Napkin AI, editorial review by María López Botín. See methodology for our use policy.
Recall context: why this comparison's primary purpose is replacement planning
See our ByHeart brand hub for the full recall timeline. Summary:
- Class I nationwide recall since November 2025
- C. botulinum Type A confirmed in ByHeart's organic whole milk powder supply, genetically matched to finished product
- 51 infant hospitalizations across 19 states
- Every batch ever produced recalled
- FDA investigation ongoing; return-to-market timeline in months, not weeks
- FDA warning letters issued to retailers stocking recalled product
For families comparing ByHeart against Earth's Best, the only defensible choice as of early 2026 is Earth's Best (or any other active-supply alternative, see our Atlas changelog for updates). Below we document the pre-recall compositional differences for context and as a reference for when ByHeart returns.
Compositional differences that actually matter
1. Organic certification: Earth's Best has USDA Organic, ByHeart does not
Earth's Best Organic Dairy carries USDA Organic (NOP) and Non-GMO Project Verified. ByHeart Whole Nutrition is NOT USDA Organic — despite marketing "organic whole milk" as its protein source, the finished formulation is not USDA Organic certified (some added micronutrients and processing aids are not organic). ByHeart carries Clean Label Project Purity Award and Non-GMO Project Verified instead.
For parents whose shortlist requires USDA Organic, Earth's Best wins regardless of recall status.
2. Bioactive stack: ByHeart had richer bioactives pre-recall
ByHeart pre-recall: 2'-FL HMO, lactoferrin, and GOS prebiotic. The richest bioactive stack of any US formula.
Earth's Best: FOS prebiotic only. No HMO, no lactoferrin, no probiotic.
For bioactive depth, ByHeart wins decisively when available. During the recall, the closest bioactive-rich active US option is Similac 360 Total Care (5 HMOs, non-organic) or Enfamil Enspire (2'-FL, MFGM, and lactoferrin, non-organic). For bioactive depth and organic certification, no currently-active widely-available US SKU exists. See 2'-FL HMO explainer and lactoferrin explainer.
3. Protein composition: 80:20 vs 60:40 whey:casein
ByHeart used 80:20 whey:casein, closer to early breast-milk ratio (roughly 80:20 in first 1-2 months). Achieved via whole cow milk, added alpha-lactalbumin, and whey protein concentrate.
Earth's Best uses 60:40, the conventional US/EU infant formula standard.
Neither is clinically superior; 60:40 is the regulatory baseline adequate for all term infants.
4. Fat blend: whole-milk fat palm-free vs vegetable oil blend with palm and soy
ByHeart: whole-milk fat and sunflower/rapeseed/coconut. No palm oil.
Earth's Best: organic palm olein, soybean oil, and organic coconut and organic safflower oil. Palm and soy present.
For families avoiding palm and/or soy, ByHeart's pre-recall profile matched (closest active replacement today: Kendamil Organic via EU import, EU Organic, whole-milk fat, and palm-free). Earth's Best's palm and soy composition is standard conventional-US-organic approach. See the palm oil explainer.
5. Prebiotic: different prebiotic classes
ByHeart: GOS (galacto-oligosaccharides). Earth's Best: FOS (fructo-oligosaccharides). Neither is clinically superior; different prebiotic fiber classes.
6. WIC eligibility: Earth's Best's decisive advantage for budget-constrained families
Earth's Best Organic Dairy is WIC-approved in several US states (check your state's WIC-approved product list). For WIC-eligible families, Earth's Best is effectively free.
ByHeart was not WIC-eligible anywhere (not the right certification/contract posture). Pre-recall, ByHeart families paid out-of-pocket exclusively.
For budget-constrained families with WIC access covering Earth's Best, the price comparison isn't "ByHeart $1.88 vs Earth's Best $1.29", it's "ByHeart $1.88 vs Earth's Best $0."
7. Recall history: extreme difference
Earth's Best: no recall history. Oldest continuously-produced US organic infant formula (since 1985), clean track record.
ByHeart: two recalls in short operating history:
- 2022 voluntary limited-lot Cronobacter recall, no infant illnesses linked
- 2025 nationwide Class I recall (ongoing), botulism outbreak, 51 hospitalizations, all batches, supply chain contamination
See our US formula recall history.
8. Price per ounce
Pre-recall: ByHeart ~$1.88/oz, Earth's Best ~$1.29/oz. ~46% difference in Earth's Best's favor. With WIC coverage on Earth's Best for eligible families, the difference reaches 100% (Earth's Best free).
Regulatory framework
Both complied with FDA 21 CFR Part 107. Earth's Best adds USDA Organic (NOP); ByHeart does not. ByHeart's recall is an FDA enforcement action under FSMA recall authority (Class I = highest severity).
Real-world parent experience
Following site methodology, the observations below come from my personal use across both kids plus a stable pool of parent-feedback notes from families. They carry the parent-experience label rather than being claimed as regulatory or clinical facts, because individual infant variation on stool consistency, smell preference, and mixability is large enough that any specific point can reverse for a specific baby. Read these as context, not prediction.
Smell and taste. ByHeart pre-recall had a rich creamy profile from the whole-milk fat. Earth's Best has a cleaner, more neutral profile — US-standard formula sensory character. Most infants accept either.
Mixability. Both use standard US-format containers. Earth's Best's 23.2 oz value-size fits typical US pantry storage.
Stool consistency. ByHeart families pre-recall reported moderate- to-soft stools (whole-milk fat, lactoferrin, and HMO contribution). Earth's Best families report moderate firmness typical of palm-inclusive FOS formulas. Neither is concerning.
Switching from ByHeart (remaining stock, if any, you should not have any per recall) to Earth's Best. Use an extended 7-10 day gradual transition. Multiple simultaneous changes: whole-milk fat → palm and soy vegetable blend, HMO and lactoferrin removal, GOS → FOS prebiotic class shift, 80:20 → 60:40 whey:casein. Expect 7-14 days of stool and gas pattern adjustment. For a smoother transition that preserves whole-milk fat and palm-free: Kendamil Organic (EU import via Organic's Best), or Kendamil Classic (non-organic, cheaper).
Verdict: what to pick now
Pick Earth's Best Organic Dairy (recommended for families choosing now):
- Active supply, USDA Organic, and FDA-registered
- WIC-eligible in several US states (may be decisive)
- Broad US supermarket availability
- Lowest per-ounce USDA Organic price
- Clean recall history
Alternative: Kendamil Organic Stage 1 (if ByHeart's whole-milk fat and palm-free profile was your driver):
- Active supply, EU Organic, and UK Soil Association
- Whole-milk fat and palm-free (matches ByHeart's fat approach)
- GOS prebiotic (different from ByHeart's fuller stack but closer than Earth's Best's FOS-only)
- 5-10 day EU shipping via Organic's Best
Do not purchase ByHeart Whole Nutrition until:
- FDA confirms investigation has closed
- ByHeart has cleared remediated supply chain
- New production batches are available (not recalled inventory)
See ByHeart brand hub and Atlas changelog for status updates.
What you can't infer from this comparison
ByHeart's recall relates to supply-chain contamination of a specific ingredient (organic whole milk powder), not to the nutritional design of the product. Post-remediation with cleared supply, ByHeart's formulation remains scientifically ambitious. Earth's Best's broader composition (palm, soy, and FOS) is standard conventional-US-organic — legitimate and FDA-compliant, different design choices from ByHeart's premium bioactive approach. Price differences reflect composition scope, brand positioning, and scale, not quality tier judgments.
Frequently asked questions
Is ByHeart safe to buy now?
What's the closest replacement for ByHeart's whole-milk fat and palm-free approach?
Is Earth's Best WIC-eligible?
Does Earth's Best have HMO or lactoferrin?
Is Earth's Best or ByHeart cheaper?
Is Earth's Best USDA Organic but ByHeart was not?
Can I transition my baby from ByHeart to Earth's Best?
Related reading
- ByHeart brand hub, full recall context
- Earth's Best brand hub
- Bobbie Original vs ByHeart Whole Nutrition, the other US organic premium vs ByHeart comparison
- ByHeart Whole Nutrition vs Kendamil Organic Stage 1, the active-supply whole-milk-fat replacement path
- Bobbie Original vs Earth's Best Dairy. USDA Organic premium vs supermarket tier
- Earth's Best Dairy vs HiPP Dutch Stage 1, budget US organic vs EU Combiotik
- US formula recall history
- Atlas changelog
Primary sources
- ByHeart, manufacturer information and recall updates. byheart.com
- Earth's Best, manufacturer product information. earthsbest.com
- FDA ByHeart recall notice, all batches, nationwide Class I. fda.gov
- USDA National Organic Program. ams.usda.gov
- FDA 21 CFR Part 107. US infant formula regulation. ecfr.gov
- USDA WIC program, state-by-state eligibility varies. fns.usda.gov/wic
This site provides research and comparisons, not medical advice. Consult your pediatrician before changing your baby's formula.

