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
| Dimension | ByHeart Whole Nutrition | Kendamil Classic Stage 1 |
|---|---|---|
| Manufacturer | ByHeart (Reading PA and Allerton IA) | Kendal Nutricare (UK) |
| Origin | USA | UK |
| Age range | 0-12 months | 0-6 months (Stage 1) |
| Regulation | FDA 21 CFR 107 (Class I recall active) | FDA 21 CFR 107 (US retail) and EU 2016/127 (UK) |
| Organic certification | Organic cow milk (marketed as organic pre-recall) | UK Red Tractor and Vegetarian Society (not organic) |
| Protein base | Whole cow milk | Whole cow milk (Jersey-cow for US line) |
| Primary carbohydrate | Lactose | Lactose |
| Prebiotic | 2'-FL HMO, additional HMO blend, and GOS | GOS and FOS (9:1 blend) |
| Lactoferrin | Added | Not added |
| MFGM | Native MFGM preserved (whole-milk-fat base) | Native MFGM preserved (whole-milk-fat base) |
| Folate form | Folic acid | Folic acid |
| Fat base | Whole-milk fat and vegetable oil blend (no palm) | Whole-milk fat, rapeseed, and coconut (no palm) |
| DHA source | Algal oil, ~13.4 mg/100 ml | Algal oil, ~16.1 mg/100 ml |
| Red flags | None (pre-recall) | None |
| Typical US price | Was | |
| Current availability | RECALLED, not for sale | Target, Amazon, us.kendamil.com |
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?
What's the closest match to ByHeart Whole Nutrition while it's recalled?
Does Kendamil Classic Stage 1 have MFGM like ByHeart did?
Is Kendamil Classic organic like ByHeart was?
Why did ByHeart's recall happen if it was FDA-registered?
Can I switch from ByHeart to Kendamil Classic?
Should I switch to Kendamil Classic or Kendamil Organic?
Related reading
- ByHeart brand hub, with full recall context
- Kendamil brand hub
- ByHeart Whole Nutrition, full SKU record, with recall banner
- Kendamil Classic Stage 1, full SKU record
- Atlas changelog, tracking ByHeart recall
- ByHeart Whole Nutrition vs HiPP Dutch Stage 1, the EU import alternative
- Bobbie Original vs Kendamil Classic Stage 1. US organic vs UK whole-milk-fat
- US formula recall history
- MFGM explainer
Primary sources
- ByHeart ingredients, official product composition (pre-recall). byheart.com
- Kendamil, official UK manufacturer information. kendamil.com
- Kendamil US: FDA-registered US retail presence. us.kendamil.com
- FDA ByHeart Class I recall: November 2025. fda.gov
- 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.

