ByHeart Whole Nutrition Infant Formula
Product identity and formulation
| Intended market | US |
|---|---|
| Comparison group | recall/do not recommend |
| Format | powder |
| Dry package mass | Not recorded |
| Age range | Not recorded |
| Label generation | pre-November 2025 product, archived manufacturer disclosure |
| Selected reference UPC | Not recorded |
| Original retailer-reported UPC | Not recorded |
| SKU | Not recorded |
exact form and pack verified in manufacturer/retailer listing
Review scope
ByHeart US recalled historical reference. FDA recall covers all batches/use-by dates of 24 oz cans and Anywhere Packs. Physical can/current lot remain unverified.
Read the review decisions and evidence limits
- correct Region: supported
- Restricted to US; cross-country ingredient, recall and price substitutions rejected.
- correct Variant: qualified
- ByHeart US recalled historical reference. FDA recall covers all batches/use-by dates of 24 oz cans and Anywhere Packs.
- package Generation: qualified
- FDA recall covers all batches/use-by dates of 24 oz cans and Anywhere Packs. Physical can/current lot remain unverified.
- ingredient Attribution: qualified
- FDA recall covers all batches/use-by dates of 24 oz cans and Anywhere Packs. Supplied transcription unchanged; read original source qualifiers and typographic footnotes.
- contaminant Claims: qualified
- FDA-hosted November 19, 2025 recall update states C. botulinum was identified in some formula samples and names IEH as a testing partner. No original full laboratory report with lot, method, result units or limits was attached. Recall overrides previous clean/testing marketing and any clinical growth evidence.
- recall Information: qualified
- FDA-hosted recall covers all batch codes and use-by dates of 24 oz cans and 0.6 oz Anywhere Packs. Consumers are instructed to stop using recalled product. Historical only; no purchase recommendations. An ended investigation or manufacturer root-cause statement does not clear recalled stock.
- clinical Claims: qualified
- The 2022 ByHeart-affiliated randomized healthy-term-infant trial demonstrated noninferiority for mean daily weight gain versus its comparator. Growth/tolerance evidence is distinct from current manufacturing or recalled-lot microbiological safety. It does not justify purchase/use or broad clinical superiority.
- certifications: qualified
- No independently rechecked current exact 24 oz certificate/expiry was established in this pass. Historic award or certified-clean claims cannot negate the all-batches recall or establish pathogen absence.
- editorial Verdict: qualified
- Regulatory/historical reference only, excluded from purchases and ordinary comparison.
- source Links: qualified
- Opened, incomplete and adjacent retrievals are distinguished. An included link is not automatic current-package proof.
- imagery: supported
- Reviewed text-only fallback. No package photograph, rights or physical-label match is claimed.
What sources establish
- FDA recall covers all batches/use-by dates of 24 oz cans and Anywhere Packs.
Recorded published ingredient declaration
Read the full published ingredient list
Organic Whole Milk, Lactose, Organic Vegetable Oils (Organic High Oleic Sunflower, Organic Low Erucic Rapeseed, Organic Coconut, Organic Sunflower), Organic Galactooligosaccharides, Organic Lactose, Alpha-Lactalbumin Whey Protein, Whey Protein Hydrolysate, Less Than 1%: Lactoferrin, DHA Algal Oil (Schizochytrium), Mortierella Alpina Oil, Vitamin A Palmitate, Vitamin D3, Vitamin E Acetate, Vitamin K1, Thiamine Hydrochloride, Riboflavin, Vitamin B6 Hydrochloride, Vitamin B12, Niacinamide, Calcium Pantothenate, Folic Acid, Biotin, Ascorbic Acid, Mixed Tocopherols, Ascorbyl Palmitate, L-Carnitine, Inositol, Calcium Phosphate, Sodium Citrate, Calcium Carbonate, Potassium Citrate, Ferrous Sulfate, Potassium Chloride, Magnesium Phosphate, Calcium Chloride, Zinc Sulfate, Cupric Sulfate, Manganese Sulfate, Potassium Iodide, Sodium Selenate, Potassium Bicarbonate, Choline Chloride
HISTORICAL ingredient declaration only; all product batches recalled, never treat this as currently purchasable
Ingredient names do not establish their amounts, exposure or suitability for a particular infant.
Composition interpretation: Reviewed interpretation of the cited published declaration. It does not verify a physical package, ingredient quantities or clinical suitability.
| Protein sources | Historical list: whole milk, alpha-lactalbumin whey and whey hydrolysate. |
|---|---|
| Carbohydrate sources | Historical list: lactose and GOS. |
| Fat sources | Historical list: milk fat, vegetable oils, DHA/ARA oils. |
| Other additions and allergen wording | Historical lactoferrin listing. Recall instructions take precedence. |
Quantitative nutrition still needs verification
NOT EXHAUSTIVELY TRANSCRIBED OR PACKAGE-MATCHED: numeric per-100-kcal vitamin/mineral composition still requires exact package label verification. Ingredients supply names of fortificants, not amounts.
Published labels and source-specific nutrition
Each disclosure below keeps its own package, market, source and observation date. Earlier, alternate and parallel references are not merged into the selected formulation. None verifies the physical can or a manufacturing lot.
Parallel or alternate reference: ByHeart Whole Nutrition Infant Formula, 24 oz container
- Stage or age
- Not established
- Label generation
- Not established
- Source SKU
- Not established
- Source UPC
- Not established
Historical manufacturer declaration only; FDA recall covers all batches/use-by dates of 24 oz cans. Full ingredient qualifiers retained; no exact historical quantitative panel securely captured. Marketing/purchase links and clinical trial do not override recall; not a current purchase candidate.
Scope and limitations: Historical manufacturer declaration only; FDA recall covers all batches/use-by dates of 24 oz cans. Full ingredient qualifiers retained; no exact historical quantitative panel securely captured. Marketing/purchase links and clinical trial do not override recall; not a current purchase candidate.
Ingredient declaration for this source reference
Organic whole milk*, Lactose, Organic Vegetable oils ( organic high oleic sunflower, organic low erucic rapeseed, organic coconut, organic sunflower), organic galactooligosaccharides°, organic lactose, alpha-lactalbumin** whey protein, whey protein hydrolysate, less than 1%: lactoferrin***, dha algal oil8 (schizochytrium), mortierella alpina oil¥, vitamin a palmitate, vitamin d3, vitamin e acetate, vitamin k1, thiamine hydrochloride, riboflavin, vitamin b6 hydrochloride, vitamin b12, niacinamide, calcium pantothenate, folic acid, biotin, ascorbic acid, mixed tocopherols, ascorbyl palmitate, l-carnitine, inositol, calcium phosphate, sodium citrate, calcium carbonate, potassium citrate, ferrous sulfate, potassium chloride, magnesium phosphate, calcium chloride, zinc sulfate, cupric sulfate, manganese sulfate, potassium iodide, sodium selenate, potassium bicarbonate, choline chloride. *FIRST US INFANT FORMULA TO INCLUDE ORGANIC, GRASS-FED WHOLE MILK **FIRST US INFANT FORMULA AT BREAST MILK LEVELS***A KEY PROTEIN FOUND IN BREAST MILK AND COLOSTRUM°A PREBIOTIC FIBER 8OMEGA-3 FATTY ACID¥OMEGA-6 FATTY ACID
A readable exact-reference quantitative nutrient panel is not recorded for this version.
Original supplied identity and ingredient snapshot (2026-10-13)
ByHeart Whole Nutrition Infant Formula. Recorded dry mass: Not established.
Organic Whole Milk, Lactose, Organic Vegetable Oils (Organic High Oleic Sunflower, Organic Low Erucic Rapeseed, Organic Coconut, Organic Sunflower), Organic Galactooligosaccharides, Organic Lactose, Alpha-Lactalbumin Whey Protein, Whey Protein Hydrolysate, Less Than 1%: Lactoferrin, DHA Algal Oil (Schizochytrium), Mortierella Alpina Oil, Vitamin A Palmitate, Vitamin D3, Vitamin E Acetate, Vitamin K1, Thiamine Hydrochloride, Riboflavin, Vitamin B6 Hydrochloride, Vitamin B12, Niacinamide, Calcium Pantothenate, Folic Acid, Biotin, Ascorbic Acid, Mixed Tocopherols, Ascorbyl Palmitate, L-Carnitine, Inositol, Calcium Phosphate, Sodium Citrate, Calcium Carbonate, Potassium Citrate, Ferrous Sulfate, Potassium Chloride, Magnesium Phosphate, Calcium Chloride, Zinc Sulfate, Cupric Sulfate, Manganese Sulfate, Potassium Iodide, Sodium Selenate, Potassium Bicarbonate, Choline Chloride
Original declaration sourceTesting evidence and its limits
No accessible exact-lot numerical original laboratory report verified in this pass
FDA aggregate survey cannot be assigned to the SKU. Consumer Reports sample results must be attributed only to the exact format tested.
Read the recorded contaminant evidence
- FDA market survey
- FDA survey analyzed 312 formula samples across 16 brands. Aggregate numerical values and tested PFAS compounds cannot be attributed to this specific SKU without a manufacturer/lot crosswalk.
- Consumer Reports
- Consumer Reports 2025/2026 researched powdered formulas; product/variant/method/sample-specific numerical lab data not independently collected into this record.
- Heavy metals
- No publicly verifiable original numerical test report with exact lot/method/LOQ attached to this record
- Targeted PFAS compounds
- No exact lot analyte table and LOQ attached
- Fluorine screens
- NOT ASSESSED: must not infer from targeted PFAS screen
- Microbiological testing
- No exact-lot manufacturing microbiological certificate of analysis attached; recalls take priority over statements of testing
- Reporting limits
- NOT VERIFIED for product-specific samples
- Non-detect interpretation
- Any future non-detect must be described as below the method-specific detection/reporting capability, not absent.
Certification claims and scope
No independently rechecked current exact 24 oz certificate/expiry was established in this pass. Historic award or certified-clean claims cannot negate the all-batches recall or establish pathogen absence.
Earlier recorded certification claims
EXACT SKU / CERTIFICATE / EXPIRY NOT ESTABLISHED
Not independently verified for exact UPC and date
USDA Organic when substantiated evaluates organic agricultural standards; other certifications address their specific scope and do not automatically establish heavy-metal or pathogen absence.
Recall information
ALL BATCHES/LOTS RECALL; DO NOT RECOMMEND
Reviewed editorial assessment
Do not feed or recommend recalled ByHeart products. Historical testing or an ended outbreak does not clear remaining recalled formula.
Recorded cautions and use limits
Do not feed or recommend recalled ByHeart products. Historical testing or an ended outbreak does not clear remaining recalled formula.
- Powdered infant formula is not sterile; follow current official preparation, safe-water, and storage instructions, particularly for newborns under 2 months, premature infants, and immunocompromised infants.
- Only use formula manufactured, labeled and authorized for the intended country; check exact SKU and lot-specific FDA/FSA recall notices.
- Cow- and goat-milk formulas are not substitutes for a prescribed extensively hydrolyzed or amino-acid allergy formula.
- Manufacturer certification, organic production, ingredient-free claims and marketing language do not establish contaminant absence or individual-lot safety.
- DO NOT USE OR RECOMMEND: all lots/batches subject to product-wide recall
Remaining evidence limits
- Product route redirects to homepage. A cached historical search result is not promoted to current exact-lot/formulation data; recalled product remains historical.
- No original full laboratory report with lot, method, result units or limits was attached. Recall overrides previous clean/testing marketing and any clinical growth evidence.
- Historic award or certified-clean claims cannot negate the all-batches recall or establish pathogen absence.
- Growth/tolerance evidence is distinct from current manufacturing or recalled-lot microbiological safety. It does not justify purchase/use or broad clinical superiority.
- Historical only; no purchase recommendations. An ended investigation or manufacturer root-cause statement does not clear recalled stock.
- No exhaustive docket search or claim that lawsuits are absent. FDA recall findings and manufacturer statements are not court findings.
- Live marketing/cart text and cached pre-recall prices do not establish appropriate current sale or safe use.
- Physical can, manufacturing lot and expiry have not been inspected.
Read the original research issue queue
No physical package and exact production lot verified
Evidence needed to resolve this question
Exact can photos: all sides, UPC, lot, best-before, full ingredient and nutrition panels
No matching current-lot original numerical testing with method/limits
Evidence needed to resolve this question
Original lab report with analytes, test methods, numerical values/units and LOD/LOQ
Complete exact-product quantitative nutrient values not transcribed
Evidence needed to resolve this question
Manufacturer package-matched per-100-kcal nutrition panel
Exact UPC/expiry/scoped certification not verified
Evidence needed to resolve this question
Certification registry matching current UPC/label generation
Archived label for historical record
Evidence needed to resolve this question
Archived label for historical record
Final FDA root-cause report
Evidence needed to resolve this question
Final FDA root-cause report
Do not revive for sale without regulator-confirmed clearance
Evidence needed to resolve this question
Do not revive for sale without regulator-confirmed clearance
All-batch or all-lot recall; exclude from active shopping interface
Evidence needed to resolve this question
Retain regulator notice; do not auto-enable shopping links
Current review by research field
These reviews record what each source establishes and what remains unknown. Completion of a source review does not imply a clean laboratory result, certification, clinical outcome or legal clearance.
Nutrition: reviewed 2026-10-14
Historical manufacturer full ingredient declaration and FDA 24 oz identity are retained; no securely rechecked complete quantitative panel was captured from the live product route.
Limits: Product route redirects to homepage. A cached historical search result is not promoted to current exact-lot/formulation data; recalled product remains historical.
Testing: reviewed 2026-10-14
FDA-hosted November 19, 2025 recall update states C. botulinum was identified in some formula samples and names IEH as a testing partner.
Limits: No original full laboratory report with lot, method, result units or limits was attached. Recall overrides previous clean/testing marketing and any clinical growth evidence.
Certification scope: reviewed 2026-10-14
No independently rechecked current exact 24 oz certificate/expiry was established in this pass.
Limits: Historic award or certified-clean claims cannot negate the all-batches recall or establish pathogen absence.
Clinical claims: reviewed 2026-10-14
The 2022 ByHeart-affiliated randomized healthy-term-infant trial demonstrated noninferiority for mean daily weight gain versus its comparator.
Limits: Growth/tolerance evidence is distinct from current manufacturing or recalled-lot microbiological safety. It does not justify purchase/use or broad clinical superiority.
Regulatory and recall review: reviewed 2026-10-14
FDA-hosted recall covers all batch codes and use-by dates of 24 oz cans and 0.6 oz Anywhere Packs. Consumers are instructed to stop using recalled product.
Limits: Historical only; no purchase recommendations. An ended investigation or manufacturer root-cause statement does not clear recalled stock.
Legal-search scope: reviewed 2026-10-14
Separate limited public searches for ByHeart infant-botulism complaint/lawsuit records did not yield an original filing securely inspected and matched in returned sources.
Limits: No exhaustive docket search or claim that lawsuits are absent. FDA recall findings and manufacturer statements are not court findings.
Price research: reviewed 2026-10-14
Current purchase and pricing promotion are withheld because FDA’s all-batches recall governs this historical record.
Limits: Live marketing/cart text and cached pre-recall prices do not establish appropriate current sale or safe use.
Product-specific evidence gaps
- Archived label for historical record
- Final FDA root-cause report
- Do not revive for sale without regulator-confirmed clearance
Legal history and search limits
No complete jurisdiction-by-jurisdiction litigation docket search completed. Do not interpret as a finding that no lawsuits exist.
Original working research
The supplied dossier contains 10 working observations for this product. These are not independent laboratory findings. Missing citations, methods, quantities and lot matches remain missing; an entry's wording does not establish that its claim has been verified.
Read every original working-evidence entry
product identity
exact form and pack verified in manufacturer/retailer listing
- Analyte / numeric-result classification
- Not recorded; original product-specific numeric laboratory result: no
- Testing organization / laboratory
- Not recorded
- Method / test date / lot
- Not recorded
- Original quantity / unit / detection limits
- Not recorded
published ingredient completeness
Full published declaration captured
Attributed entry source (scope and limitations)
- Analyte / numeric-result classification
- Not recorded; original product-specific numeric laboratory result: no
- Testing organization / laboratory
- Not recorded
- Method / test date / lot
- Not recorded
- Original quantity / unit / detection limits
- Not recorded
independent testing
No accessible exact-lot numerical original laboratory report verified in this pass
- Analyte / numeric-result classification
- Not recorded; original product-specific numeric laboratory result: no
- Testing organization / laboratory
- Not recorded
- Method / test date / lot
- Not recorded
- Original quantity / unit / detection limits
- Not recorded
laboratory report original
No publicly verifiable original numerical test report with exact lot/method/LOQ attached to this record
- Analyte / numeric-result classification
- Not recorded; original product-specific numeric laboratory result: no
- Testing organization / laboratory
- Not recorded
- Method / test date / lot
- Not recorded
- Original quantity / unit / detection limits
- Not recorded
PFAS targeted
No exact lot analyte table and LOQ attached
- Analyte / numeric-result classification
- Not recorded; original product-specific numeric laboratory result: no
- Testing organization / laboratory
- Not recorded
- Method / test date / lot
- Not recorded
- Original quantity / unit / detection limits
- Not recorded
total fluorine
NOT ASSESSED: must not infer from targeted PFAS screen
- Analyte / numeric-result classification
- Not recorded; original product-specific numeric laboratory result: no
- Testing organization / laboratory
- Not recorded
- Method / test date / lot
- Not recorded
- Original quantity / unit / detection limits
- Not recorded
microbiological
No exact-lot manufacturing microbiological certificate of analysis attached; recalls take priority over statements of testing
- Analyte / numeric-result classification
- Not recorded; original product-specific numeric laboratory result: no
- Testing organization / laboratory
- Not recorded
- Method / test date / lot
- Not recorded
- Original quantity / unit / detection limits
- Not recorded
certification
EXACT SKU / CERTIFICATE / EXPIRY NOT ESTABLISHED
- Analyte / numeric-result classification
- Not recorded; original product-specific numeric laboratory result: no
- Testing organization / laboratory
- Not recorded
- Method / test date / lot
- Not recorded
- Original quantity / unit / detection limits
- Not recorded
quantitative nutrition
NOT EXHAUSTIVELY TRANSCRIBED OR PACKAGE-MATCHED: numeric per-100-kcal vitamin/mineral composition still requires exact package label verification. Ingredients supply names of fortificants, not amounts.
- Analyte / numeric-result classification
- Not recorded; original product-specific numeric laboratory result: no
- Testing organization / laboratory
- Not recorded
- Method / test date / lot
- Not recorded
- Original quantity / unit / detection limits
- Not recorded
litigation
No complete jurisdiction-by-jurisdiction litigation docket search completed. Do not interpret as a finding that no lawsuits exist.
- Analyte / numeric-result classification
- Not recorded; original product-specific numeric laboratory result: no
- Testing organization / laboratory
- Not recorded
- Method / test date / lot
- Not recorded
- Original quantity / unit / detection limits
- Not recorded
Source rechecks and original source relationships
Read the recorded source-check outcomes
- adjacent. Source review 2026-10-14: November 19, 2025 updated announcement; all batch codes and use-by dates for 24 oz cans and 0.6 oz packets. Do not use recalled product. Physical can and lot remain unverified. FDA ByHeart all-batches recall: match scope
- opened. FDA market list checked; not FDA endorsement, currentness assurance or recall all-clear. FDA infant formulas marketed in the US: match scope
- adjacent. Source review 2026-10-14: Full ingredients and qualifiers inspected as historical reference. All-batches recall controls over marketing. Live product route no longer provides a complete numeric panel. Physical can and lot remain unverified. byheart.com: match scope
- opened. Source review 2026-10-14: ByHeart-affiliated double-blind healthy-term trial with mean daily weight-gain noninferiority. Does not establish recalled-lot microbiological safety. Physical can and lot remain unverified. Kuehn et al. 2022: protein-formula randomized trial: match scope
Read the original source relationships (4)
- regulatory market list
Recorded 2026-10-13. Match: marketed name; not exact lot.
- product or regulatory primary
Recorded 2026-10-13. Match: see findings; may be a related pack or manufacturer family.
- product or regulatory primary
Recorded 2026-10-13. Match: see findings; may be a related pack or manufacturer family.
- published full ingredient declaration
Recorded 2026-10-13. Match: reference disclosure only; exact can batch not scanned. HISTORICAL ingredient declaration only; all product batches recalled, never treat this as currently purchasable
Sources and their scope
- byheart.com
Source match and limitations
Match scope: published_list_only_not_physical_lot; reference disclosure only; exact can batch not scanned
- HISTORICAL ingredient declaration only; all product batches recalled, never treat this as currently purchasable
- Editorial recheck: adjacent. Source review 2026-10-14: Full ingredients and qualifiers inspected as historical reference. All-batches recall controls over marketing. Live product route no longer provides a complete numeric panel. Physical can and lot remain unverified.
- FDA infant formulas marketed in the US
Source match and limitations
Match scope: marketed name; not exact lot
- Editorial recheck: opened. FDA market list checked; not FDA endorsement, currentness assurance or recall all-clear.
- FDA ByHeart all-batches recall
Source match and limitations
Match scope: see findings; may be a related pack or manufacturer family; verify_region_and_size; product_family_or_lot_requires_confirmation
- Shared reference; verify current status before publishing
- Editorial recheck: adjacent. Source review 2026-10-14: November 19, 2025 updated announcement; all batch codes and use-by dates for 24 oz cans and 0.6 oz packets. Do not use recalled product. Physical can and lot remain unverified.
- www.fda.gov
Source match and limitations
Match scope: see findings; may be a related pack or manufacturer family
- Kuehn et al. 2022: protein-formula randomized trial
Source match and limitations
Match scope: Exact product matching is not established.
- ByHeart-affiliated double-blind healthy-term trial with mean daily weight-gain noninferiority. Does not establish recalled-lot microbiological safety.
- Editorial recheck: opened. Source review 2026-10-14: ByHeart-affiliated double-blind healthy-term trial with mean daily weight-gain noninferiority. Does not establish recalled-lot microbiological safety. Physical can and lot remain unverified.