US: recall/do not recommend

ByHeart Whole Nutrition Infant Formula

Product imagery is awaiting package matching and image-rights review.

Recall exclusion

Research dossier dated . This is not a live recall-check date.

Research dossier reviewed for publication . This approves the scoped research presentation, independently of its product assessment.

Latest recorded regulatory check . This check does not establish an all-clear for other lots.

Editorial publication approval recorded .

How we evaluate formula

Product identity and formulation

Intended marketUS
Comparison grouprecall/do not recommend
Formatpowder
Dry package massNot recorded
Age rangeNot recorded
Label generationpre-November 2025 product, archived manufacturer disclosure
Selected reference UPCNot recorded
Original retailer-reported UPCNot recorded
SKUNot recorded

exact form and pack verified in manufacturer/retailer listing

A published listing is a source for the cited label. The current physical can and lot have not been verified.

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ByHeart US recalled historical reference.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.

Reviewed 2026-10-14 by Codex (AI-assisted editorial review, authorized by the site owner).

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ByHeart US recalled historical reference.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

These findings reflect the dated source review and its formulation uncertainties. They do not verify a current physical can, lot or clinical outcome.

  • FDA recall covers all batches/use-by dates of 24 oz cans and Anywhere Packs.

Read the source matches and limitations alongside these findings.

Recorded published ingredient declaration

This declaration belongs to the selected published reference. Read the cited original for its formatting, footnotes and compound-ingredient qualifiers. 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.

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

Ingredient declaration source; recorded 2026-10-13.

Source type: manufacturer historic disclosure.

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 sourcesHistorical list: whole milk, alpha-lactalbumin whey and whey hydrolysate.
Carbohydrate sourcesHistorical list: lactose and GOS.
Fat sourcesHistorical list: milk fat, vegetable oils, DHA/ARA oils.
Other additions and allergen wordingHistorical lactoferrin listing. Recall instructions take precedence.

Explore the formula education guides.

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.

A verified numeric nutrient panel is not recorded. Ingredient names supply neither per-100-kcal nutrient amounts nor prepared-calorie yield.

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

US, powder. Observed 2026-10-14 by Codex AI-assisted source review. Source publication date not established.

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

Published allergen wording: contains: milk

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

HISTORICAL ingredient declaration only; all product batches recalled, never treat this as currently purchasable

Original declaration source

Testing 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.

No original numerical laboratory report with an exact lot, method and reporting limits is attached to this record. Missing results do not mean zero contamination.

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.

A certification claim has not been verified for this exact current SKU. Organic production standards do not establish contaminant absence or sterility.

Recall information

ALL BATCHES/LOTS RECALL; DO NOT RECOMMEND

The dossier date is not a live recall check. Match the exact product, country, lot and expiry date against the regulator's notice.

Read the separately checked regulatory notices.

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

These cautions reflect the recorded source review. Read them alongside the reviewed assessment and source limitations.

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

Original open issues are preserved as dated provenance. The review above records subsequent qualifications; source-level review does not verify a physical can or laboratory result.

  • No physical package and exact production lot verified

    Status: open. Priority: high.

    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

    Status: open. Priority: high.

    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

    Status: open. Priority: medium.

    Evidence needed to resolve this question

    Manufacturer package-matched per-100-kcal nutrition panel

  • Exact UPC/expiry/scoped certification not verified

    Status: open. Priority: medium.

    Evidence needed to resolve this question

    Certification registry matching current UPC/label generation

  • Archived label for historical record

    Status: open. Priority: medium.

    Evidence needed to resolve this question

    Archived label for historical record

  • Final FDA root-cause report

    Status: open. Priority: medium.

    Evidence needed to resolve this question

    Final FDA root-cause report

  • Do not revive for sale without regulator-confirmed clearance

    Status: open. Priority: medium.

    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

    Status: open. Priority: critical.

    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.

Codex AI-assisted source review; 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.

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.

Codex AI-assisted source review; 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.

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.

Codex AI-assisted source review; 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.

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.

Codex AI-assisted source review; 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.

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.

Codex AI-assisted source review; 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.

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.

Codex AI-assisted source review; 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.

No primary finding is attributed for this field. This entry records the review's scope and evidence gap.

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.

Codex AI-assisted source review; 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.

Product-specific evidence gaps

  • Archived label for historical record
  • Final FDA root-cause report
  • Do not revive for sale without regulator-confirmed clearance

These are the original dossier's specific gaps. Later source review above may resolve a published-reference question while physical package and lot verification remain separate.

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

Recorded status: information captured requires verification. Scope: not current lot certification. Source classification: secondary working dossier or qualifying source.

Source not attributed in the supplied entry. No citation is inferred from the product's other links.

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

Recorded status: information captured requires verification. Scope: not current lot certification. Source classification: secondary working dossier or qualifying source.

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

Recorded status: information captured requires verification. Scope: not current lot certification. Source classification: secondary working dossier or qualifying source.

Source not attributed in the supplied entry. No citation is inferred from the product's other links.

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

Recorded status: information captured requires verification. Scope: not current lot certification. Source classification: secondary working dossier or qualifying source.

Source not attributed in the supplied entry. No citation is inferred from the product's other links.

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

Recorded status: information captured requires verification. Scope: not current lot certification. Source classification: secondary working dossier or qualifying source.

Source not attributed in the supplied entry. No citation is inferred from the product's other links.

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

Recorded status: information captured requires verification. Scope: not current lot certification. Source classification: secondary working dossier or qualifying source.

Source not attributed in the supplied entry. No citation is inferred from the product's other links.

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

Recorded status: information captured requires verification. Scope: not current lot certification. Source classification: secondary working dossier or qualifying source.

Source not attributed in the supplied entry. No citation is inferred from the product's other links.

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

Recorded status: information captured requires verification. Scope: not current lot certification. Source classification: secondary working dossier or qualifying source.

Source not attributed in the supplied entry. No citation is inferred from the product's other links.

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.

Recorded status: information captured requires verification. Scope: not current lot certification. Source classification: secondary working dossier or qualifying source.

Source not attributed in the supplied entry. No citation is inferred from the product's other links.

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.

Recorded status: information captured requires verification. Scope: not current lot certification. Source classification: secondary working dossier or qualifying source.

Source not attributed in the supplied entry. No citation is inferred from the product's other links.

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)

Sources and their scope

A source can describe a brand, a related package or a specific label. Its presence does not verify the formula in a physical can or its current lot.

  1. byheart.com. Recorded access: 2026-10-13.
    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.
  2. FDA infant formulas marketed in the US. Recorded access: 2026-10-13. Source rechecked: 2026-10-14.
    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.
  3. FDA ByHeart all-batches recall. Recorded access: 2026-10-13.
    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.
  4. www.fda.gov. Recorded access: 2026-10-13.
    Source match and limitations

    Match scope: see findings; may be a related pack or manufacturer family

    • Kuehn et al. 2022: protein-formula randomized trial. Recorded access: 2026-10-14. Source rechecked: 2026-10-14.
      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.