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Formula Atlas
EU vs US Comparison

ByHeart Whole Nutrition vs Kendamil Classic Stage 1 - Two Whole-Milk-Fat Flagships

The two premium whole-milk-fat Stage 1 formulas compared: ByHeart Whole Nutrition (US, 5 HMOs, lactoferrin, under Class I recall since Nov 2025) vs Kendamil Classic Stage 1 (UK, GOS+FOS, no palm oil, FDA-registered). Composition, recall context, and when each fits.

By María López Botín· Last reviewed · 7 min read
ByHeart Whole Nutrition
ByHeart Whole Nutrition

ByHeart · Stage 1 · US

Kendamil Classic Stage 1
Kendamil Classic Stage 1

Kendamil · Stage 1 · GB

On this page
  1. Why this comparison matters
  2. Important: active recall notice
  3. At a glance
  4. Compositional differences that actually matter
  5. Regulatory framework and the recall
  6. Real-world parent experience
  7. Verdict: when to pick each
  8. What you can't infer from this comparison
  9. Frequently asked questions
  10. Related reading
  11. Primary sources
By María López Botín · Mother of 2, researching infant formula and infant nutrition since 2018

Before November 2025, ByHeart Whole Nutrition and Kendamil Classic Stage 1 were the two most closely-matched premium Stage 1 formulas at US retail. Both use whole cow milk as the primary fat source (preserving native MFGM structure). Both skip palm oil. Both are FDA-registered. Both are widely retailed. They diverge mainly on bioactive strategy: ByHeart layered 5 HMOs plus lactoferrin; Kendamil Classic uses GOS and FOS prebiotic blend without HMOs. On November 11, 2025, ByHeart issued a Class I voluntary recall covering every batch of Whole Nutrition ever produced. The recall remains active. Kendamil Classic is the stable whole-milk-fat alternative for parents who had chosen ByHeart.

ByHeart Whole Nutrition and Kendamil Classic Stage 1 are both whole- milk-fat Stage 1 formulas at US retail. ByHeart (pre-recall) added 5 HMOs, lactoferrin, and GOS; Kendamil adds GOS and FOS prebiotic blend. Both skip palm oil, both FDA-registered. Current reality: ByHeart is under Class I nationwide recall since November 2025 over Clostridium botulinum contamination. Kendamil Classic is the stable whole-milk- fat alternative, closest compositional match available now.

Why this comparison matters

For parents who chose ByHeart specifically for its whole-milk-fat approach, HMO breadth, and lactoferrin addition, the November 2025 recall creates an urgent question: what matches closest? Kendamil Classic is the answer. Both share the fundamental whole-milk-fat philosophy (the bigger structural decision), both FDA-registered, both US-retail. The differences are in bioactive additions layered on top.

For parents who never chose ByHeart, this comparison still matters as a benchmark, it shows what ByHeart was offering and what the EU alternative provides.

Important: active recall notice

ByHeart Whole Nutrition is under Class I nationwide voluntary recall effective November 11, 2025. All batches, all formats (cans and Anywhere Pack sticks). Reason: Clostridium botulinum Type A contamination traced to the organic whole-milk powder supply, linked to 51 infant botulism hospitalizations across 19 US states. Do not use ByHeart Whole Nutrition. Return unused product to retailer. See ByHeart brand hub and US formula recall history.

The compositional comparison below covers ByHeart's pre-recall specification.

At a glance

DimensionByHeart Whole NutritionKendamil Classic Stage 1
ManufacturerByHeart (Reading PA and Allerton IA)Kendal Nutricare (UK)
OriginUSAUK
Age range0-12 months0-6 months (Stage 1)
RegulationFDA 21 CFR 107 (Class I recall active)FDA 21 CFR 107 (US retail) and EU 2016/127 (UK)
Organic certificationOrganic cow milk (marketed as organic pre-recall)UK Red Tractor and Vegetarian Society (not organic)
Protein baseWhole cow milkWhole cow milk (Jersey-cow for US line)
Primary carbohydrateLactoseLactose
Prebiotic2'-FL HMO, additional HMO blend, and GOSGOS and FOS (9:1 blend)
LactoferrinAddedNot added
MFGMNative MFGM preserved (whole-milk-fat base)Native MFGM preserved (whole-milk-fat base)
Folate formFolic acidFolic acid
Fat baseWhole-milk fat and vegetable oil blend (no palm)Whole-milk fat, rapeseed, and coconut (no palm)
DHA sourceAlgal oil, ~13.4 mg/100 mlAlgal oil, ~16.1 mg/100 ml
Red flagsNone (pre-recall)None
Typical US priceWas $45 / 24 oz ($1.88/oz)$46 / 800 g ($1.63/oz)
Current availabilityRECALLED, not for saleTarget, Amazon, us.kendamil.com
Decision framework comparing ByHeart Whole Nutrition and Kendamil Classic Stage 1, both whole-milk-fat, both FDA-registered. ByHeart adds 5 HMOs and lactoferrin but is under active recall; Kendamil uses GOS, FOS prebiotics, and is the stable alternative
Both whole-milk-fat, FDA-registered, and no-palm flagships. ByHeart (pre-recall): 5 HMOs, lactoferrin, and MFGM-adjacent. Kendamil Classic: GOS, FOS, higher DHA, and cheaper per oz. Current reality: ByHeart under Class I nationwide recall since November 2025: Kendamil Classic is the closest structural match available now.

Visual generated with Napkin AI, editorial review by María López Botín. See methodology for our use policy.

Compositional differences that actually matter

Five dimensions that distinguished these two whole-milk-fat flagships (when both were available).

1. Shared foundation: whole-milk fat and no palm oil

Both formulas chose the same fundamental fat-blend philosophy: preserve whole cow milk's native fat structure (including native MFGM) rather than skimming off the milk fat and replacing it with vegetable oils. Neither uses palm oil.

This is the bigger structural decision, most premium Stage 1 formulas go the other direction (HiPP, Holle, Similac Pro-Advance use skimmed milk and vegetable oil blends). Kendamil Classic and ByHeart Whole Nutrition stood as the two US-retail whole-milk-fat options.

See the MFGM explainer for the bioactive mechanism and the palm oil explainer for the calcium-soap framework.

2. Bioactive additions: ByHeart layered, Kendamil simpler

Where the two diverged. ByHeart layered 2'-FL HMO plus additional HMO variants (5 HMOs total) plus added bovine lactoferrin plus GOS, a comprehensive bioactive strategy designed to match as many breast-milk components as commercial formula could. Kendamil Classic uses GOS and FOS prebiotic blend (9:1 ratio, standard EU formulation): GOS is the overlap between both formulas, but Kendamil Classic adds no HMOs and no added lactoferrin.

For the deeper mechanism on each addition see 2'-FL HMO and lactoferrin explainers.

Families weighting HMO breadth and lactoferrin addition preferred ByHeart for these specifically. Families weighting whole-milk-fat preservation and traditional composition picked Kendamil.

3. Organic certification: ByHeart claimed organic, Kendamil Classic does not

ByHeart marketed organic cow milk sourcing and was in the US organic premium tier pre-recall, though the recall source was specifically the organic whole-milk-powder supply. Kendamil Classic Stage 1 is not organic (UK Red Tractor certified, not EU Organic). Kendamil Organic Stage 1 is a separate SKU that is EU Organic certified.

If organic certification matters, Kendamil Organic Stage 1 preserves the whole-milk-fat approach and 2'-FL HMO and EU Organic. That is functionally the closest non-ByHeart option for parents wanting whole-milk-fat, HMO, and organic.

4. DHA level: Kendamil higher

Kendamil provides ~16.1 mg DHA per 100 ml (EU 2016/127 mandatory minimum met with margin). ByHeart provided ~13.4 mg per 100 ml (above FDA baseline). Both adequate for term infants; Kendamil's higher level reflects EU mandatory DHA regulation.

5. Price and availability (current)

Kendamil Classic: ~$1.63/oz at standard US retail, available next-day at Target, Amazon, Whole Foods. Not currently WIC-contracted in most states.

ByHeart: was ~$1.88/oz pre-recall. Currently not available. The Class I recall means no purchase should happen until recall is resolved and new batches clear FDA re-verification.

Regulatory framework and the recall

ByHeart Whole Nutrition complies with FDA 21 CFR Part 107 and carries FDA registration. The November 2025 Class I nationwide recall is a regulatory event (contamination traced to a specific supplier's organic whole-milk powder batches), not a compliance failure with 21 CFR 107 design requirements. FDA, CDC, and ByHeart collaborated on the recall. See the FDA outbreak investigation for the full timeline.

Kendamil Classic Stage 1 complies with FDA 21 CFR Part 107 for the US retail variant. Kendal Nutricare registered US FDA compliance in 2022. The UK-origin variant also complies with EU 2016/127. No current recall activity.

For the cross-brand recall context see US formula recall history.

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 on both formulas (pre-recall for ByHeart). 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. Both whole-milk-fat formulas have a distinctively creamier smell and flavor than skimmed-milk-based formulas. ByHeart was slightly creamier (higher proportion of whole milk); Kendamil is similar in character. Infants generally accepted both.

Mixability. Both dissolve cleanly. ByHeart occasionally left trace residue at high concentration (whole-milk fat separation at temperature variation). Kendamil similar, extra swirling resolves.

Stool consistency. ByHeart families reported softer stools (5 HMOs, added lactoferrin, and GOS combined effect). Kendamil families report soft-to-moderate consistency (GOS, FOS, and whole-milk fat). Both within normal range for healthy term infants.

Switching between them. When both available, clinically straightforward. Currently: parents on ByHeart should switch to Kendamil Classic (or Kendamil Organic if organic matters) using a 4-6 day gradual transition. The compositional similarity (both whole-milk-fat, both no palm) makes this one of the smoother brand transitions available.

Verdict: when to pick each

Pick ByHeart Whole Nutrition (when available) if:

  • HMO breadth (5 HMOs) is a bioactive priority
  • Added lactoferrin matters
  • Whole-milk fat preservation, US domestic manufacturing, and FDA registration align as a combined value
  • Current reality: product is under active Class I recall, do not purchase or use until recall is resolved. Track Atlas changelog for updates.

Pick Kendamil Classic Stage 1 if:

  • Whole-milk fat preservation matters
  • GOS and FOS prebiotic blend fits your preference (or HMO addition is not your specific priority)
  • No-palm-oil formulation is important
  • Higher DHA level is a plus
  • You want stable FDA-registered US retail availability with no current recall concerns
  • Looking for the closest structural match to ByHeart while ByHeart is recalled

Pick Kendamil Organic Stage 1 instead of Classic if:

  • You want Kendamil's whole-milk-fat approach AND 2'-FL HMO AND EU Organic certification, it provides all three in one SKU.

What you can't infer from this comparison

Neither is indicated for diagnosed cow milk protein allergy, see CMPA explained. Neither is a reflux-specific formula. Neither is appropriate for preterm infants without pediatrician guidance.

The recall status of ByHeart is dynamic. Check Atlas changelog or FDA direct notifications for current status.

Frequently asked questions

Is ByHeart Whole Nutrition still recalled?
Yes, as of this article's last-reviewed date. The November 11, 2025 Class I voluntary recall covering all batches of ByHeart Whole Nutrition remains active. 51 infant botulism hospitalizations across 19 states were linked to the product. Check the [Atlas changelog](/infant-formula-atlas/changelog) or FDA's recall page for current status before considering any purchase.
What's the closest match to ByHeart Whole Nutrition while it's recalled?
Kendamil Classic Stage 1 is the closest structural match, both use whole cow milk as primary fat source (preserving native MFGM), both skip palm oil, both are FDA-registered. The main differences: Kendamil uses GOS and FOS prebiotics instead of ByHeart's 5 HMOs and lactoferrin. For the closest compositional match INCLUDING HMO and organic, Kendamil Organic Stage 1 adds 2'-FL HMO and EU Organic to the whole-milk-fat base.
Does Kendamil Classic Stage 1 have MFGM like ByHeart did?
Yes, natively preserved through the whole-milk-fat base. Both Kendamil Classic and ByHeart (pre-recall) use whole cow milk as the primary fat source, which preserves native milk fat globule membrane structure, sphingomyelin, cholesterol, gangliosides, and glycoproteins exist in their original membrane rather than being removed with the fat fraction. This differs from skimmed-milk-plus-oils formulas (HiPP, Holle, Similac Pro-Advance) that lose native MFGM.
Is Kendamil Classic organic like ByHeart was?
No. Kendamil Classic Stage 1 carries UK Red Tractor (animal welfare and food safety) plus Vegetarian Society approval but is not certified organic. ByHeart marketed organic cow milk sourcing (the organic whole-milk-powder supply was the source of the Class I recall contamination). For the organic, whole-milk-fat, and HMO combination that ByHeart offered pre-recall, Kendamil Organic Stage 1 is the closest match.
Why did ByHeart's recall happen if it was FDA-registered?
FDA registration under 21 CFR 107 verifies compositional compliance and manufacturing controls but does not prevent rare contamination events from supplier-chain sources. The Clostridium botulinum contamination was traced to specific batches of organic whole-milk powder supplied to ByHeart's manufacturing. FDA, CDC, and ByHeart collaborated on the recall, which is the framework's regulatory response working as designed.
Can I switch from ByHeart to Kendamil Classic?
Yes, and in the current recall context, you need to. Use a 4-6 day gradual transition protocol (25%/50%/75%/100% over feeds). Because both are whole-milk-fat formulas, the fat-blend transition is smoother than switching from ByHeart to a skimmed-milk-based alternative. Expect 3-7 days of minor stool consistency adjustment, shorter than typical formula transitions. See [switching between formula brands](/infant-formula-atlas/outer/transitions/switching-between-formula-brands).
Should I switch to Kendamil Classic or Kendamil Organic?
Depends on whether organic certification matters to you. Kendamil Classic: UK Red Tractor, cheaper (~$1.63/oz), no HMO. Kendamil Organic: EU Organic certified, +2'-FL HMO included, more expensive (~$1.90/oz). For parents who chose ByHeart specifically for its organic, HMO, and whole-milk-fat combination, Kendamil Organic is the closer match. For parents weighting cost, whole-milk-fat, and stable FDA registration, Kendamil Classic is the efficient pick.

Primary sources

  1. ByHeart ingredients, official product composition (pre-recall). byheart.com
  2. Kendamil, official UK manufacturer information. kendamil.com
  3. Kendamil US: FDA-registered US retail presence. us.kendamil.com
  4. FDA ByHeart Class I recall: November 2025. fda.gov
  5. FDA 21 CFR Part 107. US infant formula regulation. ecfr.gov

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

Where to buy what we compared

Transparent about commercial relationships: links marked affiliate pay the site a commission. Links marked no commission earn nothing and are included because the product belongs in the comparison. See the full affiliate disclosure.

Last verified 2026-04-23. This site provides research and comparisons, not medical advice. Consult your pediatrician before changing your baby's formula.