HIGH

ByHeart Infant Formula Recalled Due to Botulism Risk

ByHeart announced a recall of over 6.9 million units of its infant formula on November 8, 2025, due to contamination with Clostridium botulinum. The recall affects both cans and single-serve packets sold nationwide. Parents are urged to stop using the affected products immediately to prevent serious health risks.

Quick Facts at a Glance

Recall Date
November 8, 2025
Hazard Level
HIGH
Brand
ByHeart
Category
Food & Beverages
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
INFANTS

Hazard Information

Contaminated with Clostridium botulinum

What You Should Do

Consumers who have purchased this product should not consume it. Contact ByHeart, INC. for refund or replacement information. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

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About This Product

ByHeart Whole Nutrition Infant Formula is designed for infants requiring complete nutrition. Parents often choose this brand for its organic ingredients and nutritional profile.

Why This Is Dangerous

Clostridium botulinum can produce toxins in improperly handled or contaminated food, leading to severe illness. This recall aims to prevent potential exposure to these dangerous toxins.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Parents face significant risks when using contaminated infant formula. The recall results in inconvenience and potential health hazards, emphasizing the need for immediate action.

Practical Guidance

How to identify if yours is affected

  1. Check the UPC codes on your ByHeart infant formula products.
  2. Look for the recall date on packaging to determine if your product is affected.
  3. Verify if your product is included in the specified batches by contacting ByHeart.

Where to find product info

UPC codes can typically be found on the bottom or back of the formula can or packet.

What timeline to expect

Expect a refund processing timeline of 4-6 weeks after your request is submitted.

If the manufacturer is unresponsive

  • Document all attempts to contact ByHeart.
  • Consider reaching out to the FDA if you do not receive a timely response.
  • File a complaint with the FDA if necessary.

How to prevent similar issues

  • Always check for recalls before purchasing infant formula.
  • Look for brands with a strong safety reputation.
  • Ensure products are stored properly to avoid contamination.

Documentation advice

Keep records of your purchase, any correspondence regarding the recall, and any receipts if available.

Product Details

The recall includes ByHeart Whole Nutrition Infant Formula cans (24 OZ, 680 grams) and Anywhere Packs single-serve packets (17 grams). These products were sold in various pack sizes including 1 pack, 2 packs, 4 packs, or 6 packs. The affected UPC codes include single cans and multi-packs sold at retailers across the U.S.

Key Facts

  • Recall date: November 8, 2025
  • Total units recalled: 3,482,131 cans and 3,531,901 single-serve packets
  • Contaminated with Clostridium botulinum
  • Class I recall indicating high hazard level
  • Contact ByHeart for refunds or replacements
View Original Recall on FDA - Food Safety

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
INFANTS
Injury Types
POISONING

Product Classification

Product TypeInfant Nutrition Formula
Sold At
Multiple Retailers

Product Details

Brand
ByHeart
Model Numbers
All batches and codes within expiry 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
Affected States
ALL
Report Date
December 17, 2025
Source Agency
FDA - Food Safety
Recall Status
ACTIVE

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