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
The Judicial Panel on Multidistrict Litigation consolidated federal ByHeart infant formula litigation into MDL No. 3178 in May 2026 before Judge Arun Subramanian in the Southern District of New York, beginning with roughly 20 actions. The docket centers on claims that ByHeart Whole Nutrition Infant Formula caused infant botulism in 48 hospitalized infants across 17 states—the first formula-linked outbreak of its kind per the CDC. Personal injury plaintiffs allege manufacturing defect, failure-to-warn, negligence, and breach of warranty; a separate track of putative class actions asserts economic injury under consumer protection theories.
Causation Theory
Infant botulism occurs when ingested Clostridium botulinum spores colonize the immature infant gut and produce botulinum toxin, causing constipation, poor feeding, weak cry, and progressive muscle weakness. CDC and FDA epidemiologic and laboratory data confirmed ByHeart formula as the outbreak source: every case-infant consumed the formula, FDA testing detected C. botulinum Type A in finished product samples, and whole-genome sequencing matched formula isolates to clinical isolates from sick infants and to an organic whole milk powder ingredient lot. ByHeart's own testing found 6 positive samples across three batches. The FDA root-cause investigation remained ongoing as of June 2026, with the agency confirming the bacteria's presence in ingredient and finished product but not yet determining the precise contamination mechanism.
Case Management Orders
Litigation status
MDL 3178 consolidated April 2, 2026 in the Southern District of New York before Judge Arun S. Subramanian. The docket comprises personal injury and economic loss class actions arising from the November 2025 recall of ByHeart Whole Nutrition Infant Formula following a CDC-confirmed outbreak of infant botulism. The MDL is in earliest organizational phase with leadership structure and case management protocols pending.
MDL Track
MDL 3178
ByHeart infant botulism litigation
State Court Activity
No significant state court activity reported; federal MDL is exclusive consolidation vehicle
Geographic exposure
51 infants hospitalized across 19 states with confirmed/suspected infant botulism and ByHeart formula exposure as of December 10, 2025; CDC expanded case definition to March 2022-present. FDA cannot rule out contamination across all product lots since March 2022 launch. Nationwide retail distribution through Walmart, Target, Kroger, Acme, Shaw's, and Amazon (including Guam, Puerto Rico, and 21 international markets). FDA found recalled formula still on shelves at 175+ locations across 36 states as of December 2025; warning letters issued to Target, Walmart, Kroger, and Albertsons December 12, 2025.
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 and first detected cluster. Source: CDC/FDA joint investigation (Food Poison Journal, Marler Blog).
1 confirmed case; Reading facility (Blendhouse LLC) 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).
Allerton manufacturing site (Blendhouse Allerton, LLC). 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).
4 confirmed cases; Blendhouse Portland LLC packaging facility located here. FDA March 2025 inspection classified No Action Indicated (NAI). Source: FDA Establishment Inspection Reports (EIRs) released November 26, 2025 (Food-Safety.com).
Confirmed case in Richmond; 1-year statute of limitations creates urgent screening priority. Everett v. ByHeart Inc., E.D. Ky., Case No. 5:25-cv-00422, filed Nov. 12, 2025.
Confirmed case in Flagstaff; parents of four-month-old filed federal suit after infant hospitalized, requiring nearly two weeks of care. Source: national news reporting, December 2025.
Valenzuela v. ByHeart Inc., E.D.N.Y., filed Nov. 13, 2025; MDL 3178 consolidated in S.D.N.Y. JPML transfer order issued; 19 federal actions pending in 12 judicial districts as of early 2026.
3 confirmed cases. Source: CDC case count map, December 3, 2025 (Food Poison Journal, Marler Blog).
2 confirmed cases. Source: CDC case count, December 3, 2025 (Food Poison Journal, Marler Blog).
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 Five 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 Shuts Down Pennsylvania Plant
FDA shuts down ByHeart's Reading, Pennsylvania facility after inspectors find mold in clean water tank, thousands of dead insects, roof leaks, and unreported temperature variations affecting kill steps for microbiological contaminants.
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 Initial Recall
ByHeart voluntarily recalls two specific batches (251261P2 and 251131P2) of Whole Nutrition Infant Formula. California public health officials preliminarily detect botulinum neurotoxin in opened can fed to diagnosed infant.
ByHeart Expands Recall to All Products
ByHeart expands recall to all lots and package formats of Whole Nutrition Infant Formula nationwide. Clostridium botulinum Type A later confirmed in five of 36 samples across three lots.
First Lawsuit Filed in E.D. Kentucky
Everett v. ByHeart Inc. filed in U.S. District Court for the Eastern District of Kentucky, Case No. 5:25-cv-00422, on behalf of infant hospitalized with botulism after consuming ByHeart formula.
CDC Expands Outbreak to 51 Cases, 19 States
CDC updates case count to 51 hospitalized infants across 19 states after expanding outbreak case definition. Figure later revised to 48 confirmed/probable cases in 17 states.
Plaintiffs File MDL Petition
Plaintiffs file motion to establish MDL seeking consolidation in the Southern District of New York before Judge Denise L. Cote. At least 18 federal cases pending.
MDL 3178 Centralized in S.D.N.Y.
JPML consolidates cases as In re: ByHeart, Inc., Infant Formula Marketing, Sales Practices, and Products Liability Litigation, MDL No. 3178, in the Southern District of New York before Judge Arun Subramanian. Approximately 19 actions at consolidation.
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 61 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. The docket comprises personal injury and economic loss class actions arising from the November 2025 recall of ByHeart Whole Nutrition Infant Formula following a CDC-confirmed outbreak of infant botulism. The MDL is in earliest organizational phase with leadership structure and case management protocols pending.
Key developments
Trajectory
Press and regulatory signals are moving in tandem for ByHeart Formula. The next escalation check is whether these agency actions prompt new PACER filings or MDL scheduling orders.
Editorial intelligence
MDL 3178 should stay on the lead docket watch because it is the primary consolidation vehicle for ByHeart Formula.
Generated Aug 12, 2026, 2:00 AM UTC
61 events detected
Google News (43)
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
Infant Formula Botulism Outbreaks At ByHeart And Nara Highlight Manufacturing And Contamination Risks - Where The Food Comes From
Two Organic Baby Formula Botulism Outbreaks in Seven Months Were Linked to the Same Ingredient Supplier - Medical Daily
Two formula recalls raise doubts about booming ‘better-for-you’ category - Star Tribune
The ByHeart botulism outbreak is over. As the FDA searches for the cause, these babies are still sick. - NBC News
Infant Formula Brands Behind Botulism Outbreaks Used Same Organic Whole Milk Supplier - Food Safety Magazine
Outbreak Investigation of Infant Botulism Linked to ByHeart Whole Nutrition Infant Formula - KDHE (.gov)
Organic Infant Formulas Caused Back-to-Back Botulism Outbreaks—What Gives? - Food Safety Magazine
New infant botulism outbreak puts fancy formulas under scrutiny - STAT
Nara Organics recalls infant formula due to potential risk of bacterial contamination - WOAY-TV
Publisher's Platform: FDA’s ByHeart inspection report is finally public — everyone owns the bottle - Food Safety News
Thurston County infant botulism case linked to recalled formula - KOMO
For Second Time in 7 Months, Baby Formula Linked to Infant Botulism Is Recalled - Truthout
The recall was issued after an outbreak of infant botulism across several states. Cases were reported in Pennsylvania, Washington and California. - facebook.com
Nara Organics infant formula recalled after multi-state botulism outbreak - fox5sandiego.com
Baby formula sold at Target, online recalled after WA infant, 2 others sickened - Tri-City Herald
Baby formula sold at Target recalled after WA infant, 2 others sickened - Tri-City Herald
Predictable: Two Formula Botulism Outbreaks the FDA Warned Us About Three Years Ago - Marler Blog
ByHeart recommended its customers switch to Nara. Now a second infant formula is linked to botulism. - Healthbeat
Another Fancy Formula Brand Has Been Recalled - thecut.com
Baby formula maker Nara issues US-wide recall after FDA, CDC flag infant botulism cases - The Straits Times
All Nara Organics Infant Formula Recalled Due to Botulism Concerns - Consumer Reports
Another Infant Botulism Outbreak Sickens Three, Nara Organics Formula Suspected Cause - Food Safety Magazine
Nara Organics recalls infant formula after 3 babies are diagnosed with botulism - NBC News
Botulism outbreak sickens 3 babies, including one in Washington; formula recalled - OregonLive.com
Nara Organics recalls baby formula after multistate infant botulism outbreak - PBS
Infant formula recalled after California baby sickened with botulism - Los Angeles Times
Nara Organics recalls baby formula sold at Target after multistate infant botulism outbreak - AP News
A Can of Baby Formula Shouldn’t Cause Botulism — But It Just Did, Twice in Seven Months - Marler Blog
CDC Warns of Recalled Formula After Babies Hospitalized for Botulism - Newsweek
Another Brand Of Infant Formula Recalled After Botulism Cases - Forbes
ByHeart factory inspection fails to explain botulism in formula - Crain's New York Business
FDA's ByHeart Inspection Report Is Finally Public — and It Points at the Milk — But Everyone Still Owns the Bottle - Marler Blog
Many babies sickened in ByHeart formula botulism outbreak needed more treatment after hospitalization - WFMZ.com
Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) - fda.gov
ByHeart Recalls All Baby Formula Sold Nationwide As Infant Botulism Outbreak Grows San Antonio Weather (gxAHC8K0hm) - Mshale
Ada County infant botulism case linked to ByHeart formula recall - MSN
ByHeart recalls all baby formula nationwide as infant botulism outbreak grows - MSN
Baby formula recall expanded, 84 botulism cases reported: FDA - MSN
Baby formula maker pulls all products nationwide after infant botulism outbreak - MSN
All ByHeart baby formula may be contaminated with botulism bacteria: Tests - MSN
Microbiology spectrum • Lee CC • PMID 42573255 • Journal Article.
Food chemistry • Wang Y • PMID 42447597 • Journal Article.
Applied radiation and isotopes : including data, instrumentation and methods for use in agriculture, industry and medicine • Kurnaz A • PMID 42407205 • Journal Article.
Letters in applied microbiology • Cui M • PMID 42287752 • Journal Article.
Foods (Basel, Switzerland) • Shuai J • PMID 42450467 • Journal Article.
No recent court filing signals. Monitoring is active — this section updates automatically.
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LexGenius Ranking
70Score
Court, news, and regulatory activity are elevated
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Last: Aug 12, 2026, 2:00 AM UTC
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PACER
PACER
Google News
FAERS
PubMed
Event feed
61
events detected
AI Brief
ByHeart Infant Formula remains early-stage / recently consolidated with 61 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. The docket comprises personal injury and economic loss class actions arising from the November 2025 recall of ByHeart Whole Nutrition Infant Formula following a CDC-confirmed outbreak of infant botulism. The MDL is in earliest organizational phase with leadership structure and case management protocols pending.
Key developments
Marler Blog news on Jul 17: Senator Cassidy Wants Answers from Nara Organics - ByHeart too - on Infant Botulism. So Do the Families I Represent. - Marler Blog. ‖ Food Event FDA alert on Mar 14: Food Event 2026-CFS-003786: BYHEART WHOLE NUTRITION INFANT FORMULA. ‖ PubMed research on Aug 10: Core genome and whole genome multi-locus sequence typing of Cronobacter isolates..
Generated Aug 12, 2026, 2:00 AM UTC
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