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Stop using now Food recall · FDA · Published November 8, 2025

ByHeart Infant Formula Cans Contaminated with Botulinum Toxin - Recall

ByHeart recalls infant formula cans contaminated with Clostridium botulinum. Affected products include 24oz cans sold in packs up to 6. Consumers should stop using and contact ByHeart for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #H-0249-2026FoodByHeart ›
Official FDA recall photos · click to enlarge
Take action

Contact the company

Recalling firmByHeart, INC.131 Varick St · New York, NY 10013-1410
✎ GovInfoNow plain-language explainer

ByHeart is recalling infant formula cans that may be contaminated with Clostrid: botulinum, a dangerous bacteria that can cause infant botulism. This recall affects specific packaging and batch dates. Parents should stop using these products immediately. Read more at govinfonow.com/recall/6991-byheart-infant-formula-cans-contaminated-with-botulinum-toxin-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/6991-byheart-infant-formula-cans-contaminated-with-botulinum-toxin-recall · Updated August 18, 2026 · Official notice: FDA #H-0249-2026

Cite this page

“ByHeart Infant Formula Cans Contaminated with Botulinum Toxin - Recall.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/6991-byheart-infant-formula-cans-contaminated-with-botulinum-toxin-recall. Based on FDA recall #H-0249-2026.

ByHeart, INC. recalled infant formula cans and single-serve packets due to contamination with Clostridium botulinum, according to the Food and Drug Administration on Nov. 8, 2025.

How to tell if you have it

  • Brand: ByHeart
  • Product: ByHeart Whole Nutrition Infant Formula cans 24 OZ (680 grams)
  • Product: ByHeart Whole Nutrition Infant Formula Anywhere Packs Single Serve Packet 17 grams
  • Pack sizes: 1 pack, 2 packs, 4 packs, or 6 packs
  • Expiry dates: Finished Product Quantity 08NOV2023 to 08NOV2025
  • UPC Codes: Single Can: 8 50044 96800 8; Sams Club 2PK: 00850044968893; Amazon 2PK: 00850044968053; Anywhere pack: 8 50044 96802 2; 1-Count Sample Unit Anywhere Pack: 850044968015
  • Distribution: nationwide

The hazard

The product is contaminated with Clostridium botulinum. The FDA classified the recall as Class I.

Context

GovInfoNow's records show ByHeart, INC. has one other recall on record since Dec. 11, 2022, involving Cronobacter sakazakii contamination risk. Other recent recalls of similar products include Nara Organics Infant Formula Recall (June 13, 2026), a2 Platinum Premium Infant Formula Recall (May 1, 2026), and Diva Fam Sea Moss Gel Superfood Recall (Jan. 9, 2026).

How to tell if you have this one

Check for 24oz cans labeled 'ByHeart Whole Nutrition Infant Formula' sold in packs of 1, 2, 4, or 6. Look for UPC codes: 850044968008 for single cans, 00850044968893 for Sams Club 2-packs, and others listed in the recall notice.

  • Brand
    ByHeart
  • Category
    Food
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Now

    Immediately stop using any affected ByHeart Whole Nutrition Infant Formula cans.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 39 days after the firm started it.

1. Firm started the recall: Nov 8, 202512. FDA classified it Class I: Dec 10, 202523. Published in FDA’s Enforcement Report: Dec 17, 202532025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Nara Organics Infant Formula Recall: Botulinum Contamination Risk
Nara Organicsa2 Platinum Premium Infant Formula Recall: Possible Cereulide Toxin Contamination
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Diva FamPur Aqua Sparkling Frost Cherry Limeade Recall: Undeclared Aspartame
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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #H-0249-2026 (November 8, 2025)
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA