MDL Track
MDL 3178
ByHeart infant botulism litigation
Pharmaceutical · claims alleging ByHeart infant formula was contaminated with harmful bacteria or foreign substances, causing illness in infants
Defendant
ByHeart, Inc.
MDL / Track
MDL 3178
S.D.N.Y.
Judge
Judge Arun S. Subramanian
Plaintiffs
21 pending
Bellwether / Trial
No verdicts yet
Settlement Status
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Case overview
MDL No. 3178, In re: ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, sits before Judge Arun S. Subramanian in the Southern District of New York, consolidating nine infant-injury botulism cases and ten economic-loss class actions as of April 2, 2026. The litigation traces to a November 2025 nationwide recall of all ByHeart Whole Nutrition Infant Formula after CDC and FDA linked the product to a 48-infant, 17-state botulism outbreak — the first U.S. infant botulism outbreak ever tied to formula. ByHeart carries only a $10 million defense-within-limits liability policy, with plaintiffs alleging rapid depletion by defense costs at Munger Tolles and DLA Piper.
Causation Theory
CDC and FDA epidemiologic and laboratory data concluded ByHeart Whole Nutrition Infant Formula was the outbreak source: every case-infant consumed the formula, FDA testing detected Clostridium botulinum in powdered formula samples, and whole-genome sequencing matched a formula isolate to a clinical isolate from a sick infant. By January 23, 2026, FDA reported finding C. botulinum in organic whole milk powder with genetic sequencing matching finished product and clinical isolates; by June 2026, FDA had completed on-site facility inspections but stated it "has not yet determined a root cause," with its investigation focused on incoming ingredients and the dairy supply chain.
Case Management Orders
Litigation status
MDL 3178 consolidated April 2, 2026, in the Southern District of New York before Judge Arun S. Subramanian, with 19 actions transferred at inception and modest growth to approximately 21 actions by mid-2026. The docket comprises two tracks: nine personal-injury infant botulism cases and ten economic-loss class actions. No case management order or leadership appointments have issued; the MDL remains in earliest organizational phase.
MDL Track
MDL 3178
ByHeart infant botulism litigation
State Court Activity
At least one confirmed state filing: Galindo v. ByHeart, Inc., Los Angeles County Superior Court No. 26TRCV02889 (filed August 10, 2026)
Geographic exposure
48 infants (28 confirmed, 20 probable) across 17 states per CDC final outbreak count declared February 26, 2026; onsets December 24, 2023 through November 29, 2025. All 48 hospitalized; zero deaths. Earlier expanded case definition had reached 51 cases in 19 states as of December 10, 2025. Nationwide retail distribution through Walmart, Target, Kroger, Acme, Shaw's, and Amazon (including Guam, Puerto Rico, and 21 international markets). FDA cannot rule out contamination across all product lots since March 2022 launch. Source: CDC, FDA, AP News December 10, 2025; CDC final count February 26, 2026.
8 confirmed infant botulism cases — highest state count, representing 20.5% of national cases. Illness onset dates August 9 to November 19, 2025. Source: CDC/FDA outbreak data as of December 3, 2025 (Food Poison Journal, Marler Blog).
5 confirmed cases; California Department of Public Health (CDPH) and Infant Botulism Treatment and Prevention Program (IBTPP) led outbreak identification. CDPH first detected cluster. Source: CDC/FDA joint investigation (Food Poison Journal, Marler Blog).
Blendhouse Reading LLC facility shuttered September 2023. FDA January 2024 inspection classified Official Action Indicated (OAI) for moldy water tank, leaking roof, dead insects. Source: FDA EIRs, January 2024 (Food-Safety.com).
Blendhouse Allerton, LLC manufacturing site. FDA February 2025 inspection issued Form 483 citing rodent activity, rusty surfaces, C. sakazakii-positive environmental swabs, and release of unapproved ingredient. Classified Voluntary Action Indicated (VAI). Source: FDA Form 483, February 2025 (Food-Safety.com).
Blendhouse Portland LLC packaging facility. FDA March 2025 inspection classified No Action Indicated (NAI). Two positive Cronobacter swabs during inspection; facility had not received base powder from Reading facility since December 1, 2023. Source: FDA Establishment Inspection Reports (EIRs) released November 26, 2025 (Food-Safety.com).
MDL 3178 consolidated in S.D.N.Y. before Judge Arun S. Subramanian. JPML transfer order April 2, 2026. Source: U.S. Judicial Panel on Multidistrict Litigation; LexGenius Feed.
2 confirmed cases; Wescott et al. Third Amended Complaint filed Feb. 2026 in W.D. Wash. adds supply chain defendants. Chughtai complaint filed W.D. Wash. at Seattle, noticed as tag-along to MDL 3178. Source: LexGenius Feed.
Dairy Farmers of America processing facility in Fallon supplied organic whole milk powder to ByHeart. Whole genome sequencing tied C. botulinum isolates from two samples of same lot of organic whole milk powder to clinical isolate and positive infant formula finished product. FDA inspection ongoing. Source: Food Safety Magazine, June 4, 2026; PRNewswire, Aug. 2026.
1-year statute of limitations creates urgent screening priority for earliest-exposure cases (March 2022 launch). Source: LexGenius Feed.
Key defendants
ByHeart, Inc.
Role: Manufacturer
Core defendant in infant botulism outbreak with 51 cases across 19 states. Third Amended Complaint filed Feb. 2026 in W.D. Wash. (Wescott et al.) adds supply chain defendants. Prior 2022 Cronobacter recall and August 2023 FDA Warning Letter create pattern-of-conduct exposure.
Target Corporation
Role: Retailer
Named in Wescott et al. Third Amended Complaint. Strict liability and warranty claims for retail distribution. Standard indemnity posture—likely to tender defense upstream.
Organic West, Inc.
Role: Ingredient Supplier
Added Feb. 2026 in Wescott Third Amended Complaint. Supplied whole milk powder with genetically matched C. botulinum per FDA WGS analysis. Halted pediatric milk powder sales post-recall.
Dairy Farmers of America, Inc.
Role: Processor
Added Feb. 2026 in Wescott Third Amended Complaint. Processed whole milk into contaminated powder for Organic West. Genetic sequencing links processing to finished ByHeart product.
| Defendant | Role | Intelligence Note |
|---|---|---|
| ByHeart, Inc. | Manufacturer | Core defendant in infant botulism outbreak with 51 cases across 19 states. Third Amended Complaint filed Feb. 2026 in W.D. Wash. (Wescott et al.) adds supply chain defendants. Prior 2022 Cronobacter recall and August 2023 FDA Warning Letter create pattern-of-conduct exposure. |
| Target Corporation | Retailer | Named in Wescott et al. Third Amended Complaint. Strict liability and warranty claims for retail distribution. Standard indemnity posture—likely to tender defense upstream. |
| Organic West, Inc. | Ingredient Supplier | Added Feb. 2026 in Wescott Third Amended Complaint. Supplied whole milk powder with genetically matched C. botulinum per FDA WGS analysis. Halted pediatric milk powder sales post-recall. |
| Dairy Farmers of America, Inc. | Processor | Added Feb. 2026 in Wescott Third Amended Complaint. Processed whole milk into contaminated powder for Organic West. Genetic sequencing links processing to finished ByHeart product. |
Timeline
ByHeart Recalls Batches for Cronobacter
ByHeart voluntarily recalls five batches of infant formula after sample tests positive for Cronobacter sakazakii at packaging plant. FDA subsequently issues Warning Letter citing inadequate process controls.
FDA Issues Warning Letter to ByHeart
FDA issues formal warning letter to ByHeart's Reading, Pennsylvania facility citing over 2,700 dead insects in food production areas, mold in water tanks, roof leaks, temperature control failures, and inadequate sanitation. Facility shut down September 2023.
CDC Alerts Public to Botulism Outbreak
California Department of Public Health notifies CDC of infant botulism surge linked to ByHeart formula. FDA notifies ByHeart of investigation same day.
ByHeart Issues Limited Recall; First Lawsuit Filed
ByHeart recalls two batches (251261P2, 251131P2). Everett v. ByHeart Inc. filed in E.D. Ky., Case No. 5:25-cv-00422, first federal personal injury action.
ByHeart Expands Recall to All Products
ByHeart recalls all unexpired powdered infant formula nationwide. Company later confirms Clostridium botulinum Type A in five of 36 samples across three lots.
CDC Expands Outbreak to 51 Cases, 19 States
CDC expands case definition to include all ByHeart formula produced since March 2022. Outbreak encompasses at least 51 infants in 19 states.
Plaintiffs File MDL Petition
Plaintiffs file motion to establish MDL in Southern District of New York. At least 18 federal cases pending.
CDC Declares Outbreak Over
CDC closes outbreak investigation with final count of 48 confirmed/probable cases across 17 states. No deaths reported; all infants hospitalized and treated with BabyBIG.
JPML Consolidates Cases as MDL No. 3178
Judicial Panel on Multidistrict Litigation consolidates approximately 19 federal actions into In re: ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3178, assigned to Judge Arun Subramanian in Southern District of New York.
Statute of limitations
MDL consolidation petition pending before JPML, with hearing scheduled March 2026. Outbreak period: December 2023 to December 1, 2025 per CDC. 51 infants hospitalized across 19 states. FDA confirmed C. botulinum Type A toxin in finished product and organic whole milk powder ingredient. Kentucky's 1-year SOL creates urgent screening priority for earliest-exposure cases.
⚠Kentucky
1 year from injury
Rule: Ky. Rev. Stat. § 413.140(1)(a) — products liability actions subject to 1-year SOL; discovery rule applies
Discovery: Accrues when injury is discovered or should have been discovered through reasonable diligence
First-filed ByHeart botulism case: Everett v. ByHeart, Inc., E.D. Ky. Case No. 25-cv-00422 (Nov. 12, 2025). JPML consolidation hearing scheduled March 2026.
New York
3 years from injury
Rule: N.Y. C.P.L.R. § 214(2) — strict products liability; 3-year SOL with discovery rule
Discovery: Accrues when injury and its causal link to product are discovered or reasonably discoverable
Class action filed E.D.N.Y. Nov. 13, 2025. No revival statute applicable.
California
2 years from injury
Rule: Cal. Code Civ. Proc. § 335.1 — strict liability for product defect; discovery rule codified
Discovery: Accrues when plaintiff discovers or should discover injury and its cause
12 confirmed cases, highest state count. CDPH/IBTPP leading outbreak investigation.
Texas
2 years from injury
Rule: Tex. Civ. Prac. & Rem. Code § 16.003 — products liability; discovery rule applies per Jolly v. Eli Lilly & Co.
Discovery: Accrues when injury becomes inherently undiscoverable and objectively verifiable
8 confirmed cases.
Illinois
2 years from injury
Rule: 735 Ill. Comp. Stat. 5/13-202 — strict products liability; discovery rule applies
Discovery: Accrues when plaintiff knows or reasonably should know of injury and causal connection
2 confirmed cases.
Arizona
2 years from injury
Rule: Ariz. Rev. Stat. § 12-542 — products liability; discovery rule applies
Discovery: Accrues when plaintiff discovers or reasonably should discover cause of action
5 confirmed cases.
Oregon
2 years from injury
Rule: Or. Rev. Stat. § 12.110 — products liability; discovery rule applies
Discovery: Accrues when injury and its causal connection are discovered or reasonably should be discovered
4 confirmed cases.
| State | SOL | Rule | Discovery Rule | Notes |
|---|---|---|---|---|
| ⚠Kentucky | 1 year from injury | Ky. Rev. Stat. § 413.140(1)(a) — products liability actions subject to 1-year SOL; discovery rule applies | Accrues when injury is discovered or should have been discovered through reasonable diligence | First-filed ByHeart botulism case: Everett v. ByHeart, Inc., E.D. Ky. Case No. 25-cv-00422 (Nov. 12, 2025). JPML consolidation hearing scheduled March 2026. |
| New York | 3 years from injury | N.Y. C.P.L.R. § 214(2) — strict products liability; 3-year SOL with discovery rule | Accrues when injury and its causal link to product are discovered or reasonably discoverable | Class action filed E.D.N.Y. Nov. 13, 2025. No revival statute applicable. |
| California | 2 years from injury | Cal. Code Civ. Proc. § 335.1 — strict liability for product defect; discovery rule codified | Accrues when plaintiff discovers or should discover injury and its cause | 12 confirmed cases, highest state count. CDPH/IBTPP leading outbreak investigation. |
| Texas | 2 years from injury | Tex. Civ. Prac. & Rem. Code § 16.003 — products liability; discovery rule applies per Jolly v. Eli Lilly & Co. | Accrues when injury becomes inherently undiscoverable and objectively verifiable | 8 confirmed cases. |
| Illinois | 2 years from injury | 735 Ill. Comp. Stat. 5/13-202 — strict products liability; discovery rule applies | Accrues when plaintiff knows or reasonably should know of injury and causal connection | 2 confirmed cases. |
| Arizona | 2 years from injury | Ariz. Rev. Stat. § 12-542 — products liability; discovery rule applies | Accrues when plaintiff discovers or reasonably should discover cause of action | 5 confirmed cases. |
| Oregon | 2 years from injury | Or. Rev. Stat. § 12.110 — products liability; discovery rule applies | Accrues when injury and its causal connection are discovered or reasonably should be discovered | 4 confirmed cases. |
Live intelligence
AI litigation brief
ByHeart Infant Formula remains early-stage / recently consolidated with 22 current signals in the accepted feed.
Overview
MDL 3178 consolidated April 2, 2026, in the Southern District of New York before Judge Arun S. Subramanian, with 19 actions transferred at inception and modest growth to approximately 21 actions by mid-2026. The docket comprises two tracks: nine personal-injury infant botulism cases and ten economic-loss class actions. No case management order or leadership appointments have issued; the MDL remains in earliest organizational phase.
Key developments
Trajectory
Press coverage is active. Monitor MDL 3178 for scheduling orders, CMOs, and bellwether selections that typically follow active reporting cycles on ByHeart Formula.
Editorial intelligence
MDL 3178 should stay on the lead docket watch because it is the primary consolidation vehicle for ByHeart Formula.
Generated Sep 30, 2026, 10:00 AM UTC
22 events detected
Google News (12)
FDA says infant formula 'safe.' Parents whose babies got botulism want answers - WZTV
FDA Clears ByHeart's Botulism Action Plan — Root Cause Points to a Milk Ingredient - Food & Beverage Magazine
CDC Has Closed the Nara Organics Infant Formula Botulism Outbreak at Four Babies. The Strain From One of Them Matches Four Unopened Cans of ByHeart Formula. - Marler Blog
CDC declares Nara Organics infant botulism outbreak over as genetic testing links it to 2025 ByHeart outbreak - Contemporary Pediatrics
Nara Organics Infant Formula Botulism Outbreak Ends; WGS, Supply Chain Evidence Show Link to ByHeart - Food Safety Magazine
Nara Organics Infant Formula Botulism Outbreak Ends; WGS, Supply Chain Evidence Show Link to ByHeart - food-safety.com
After 2 infant formula botulism outbreaks, families ask if warning signs were missed - KEYE
Recalled ByHeart Infant Formula Tied to a Botulism Outbreak Still Carries Use By Dates into December 2026 - Medical Daily
Senator Cassidy Wants Answers from Nara Organics - ByHeart too - on Infant Botulism. So Do the Families I Represent. - Marler Blog
US FDA urges infant-formula makers to tighten supplier oversight after product recalls, botulism outbreaks - ET HealthWorld
Outbreak Investigation of Infant Botulism: Powdered Infant Formula (June 2026) - fda.gov
What’s News in the ByHeart and Nara Infant Botulism Outbreaks - Marler Blog
Environmental science and pollution research international • Rincon EHH • PMID 42768262 • Journal Article.
Journal of food protection • Van Doren JM • PMID 42710592 • Journal Article.
The Journal of nutrition • Odamaki T • PMID 42710681 • Journal Article.
Comprehensive reviews in food science and food safety • He Y • PMID 42728788 • Journal Article.
Frontiers in microbiology • Salazar JK • PMID 42723919 • Journal Article.
No recent FDA signals. Monitoring is active — this section updates automatically.
No recent court filing signals. Monitoring is active — this section updates automatically.
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LexGenius Ranking
72Score
Court, news, and regulatory activity are elevated
Monitoring
Live
monitoring
Last: Sep 30, 2026, 10:00 AM UTC
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Source Monitoring
PACER
PACER
Google News
FAERS
PubMed
Event feed
22
events detected
AI Brief
ByHeart Infant Formula remains early-stage / recently consolidated with 22 current signals in the accepted feed.
Overview
MDL 3178 consolidated April 2, 2026, in the Southern District of New York before Judge Arun S. Subramanian, with 19 actions transferred at inception and modest growth to approximately 21 actions by mid-2026. The docket comprises two tracks: nine personal-injury infant botulism cases and ten economic-loss class actions. No case management order or leadership appointments have issued; the MDL remains in earliest organizational phase.
Key developments
WZTV news on Sep 14: FDA says infant formula 'safe.' Parents whose babies got botulism want answers - WZTV. ‖ PubMed research on Sep 22: Microplastic and endocrine disruptor contamination in infant formula and early health effects: scoping review..
Generated Sep 30, 2026, 10:00 AM UTC
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