Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

ยฉ 2026 Go Backs. All rights reserved.

Critical RiskFDA Food
Food & Beverages/Baby Food & Formula

ByHeart Whole Nutrition Infant Formula Recalled for Botulinum Contamination

Agency Publication Date: December 10, 2025
Share:
Sign in to monitor this recall

Summary

ByHeart, INC. is recalling approximately 3.48 million cans and 3.53 million single-serve packets of ByHeart Whole Nutrition Infant Formula because the product may be contaminated with Clostridium botulinum. This bacteria can cause botulism, a rare but serious paralytic illness. The recall includes 24-ounce cans sold in various pack sizes and 17-gram Anywhere Pack single-serve packets distributed nationwide through retailers like Sam's Club and Amazon.

Risk

Consumption of food contaminated with Clostridium botulinum can cause botulism, which may lead to muscle weakness, difficulty breathing, and paralysis. No illnesses have been reported to date, but the contamination poses a critical health risk to infants.

What You Should Do

  1. Check your product packaging for the following UPC codes: Single Can (8 50044 96800 8), Sam's Club 2-Pack (00850044968893), Amazon 2-Pack (00850044968053), Anywhere Pack (8 50044 96802 2), or Sample Unit Anywhere Pack (850044968015).
  2. Verify the expiration or 'Best By' dates on your product, which range from November 8, 2023, to November 8, 2025.
  3. Return the product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Return the product to the place of purchase for a full refund, or contact the manufacturer or supplier for further instructions
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away.

Affected Products

Product: ByHeart Whole Nutrition Infant Formula (24 oz / 680g)
Variants: 1 pack, 2 packs, 4 packs, 6 packs
UPC Codes:
850044968008
00850044968893
00850044968053
Date Ranges: Expiry 08NOV2023 to 08NOV2025

All batches and codes within expiry range.

Product: ByHeart Whole Nutrition Infant Formula Anywhere Packs Single Serve Packet (17g)
Variants: 14 Single Serve Packets per package, 1-Count Sample Unit
UPC Codes:
850044968022
850044968015
Date Ranges: Expiry 08NOV2023 to 08NOV2025

All batches and codes within expiry range.

Product Images

ByHeart Whole Nutrition Infant Formula, 24 oz tub

ByHeart Whole Nutrition Infant Formula, 24 oz tub

UPC Code Location, ByHeart Whole Nutrition Infant Formula, 24 oz tub

UPC Code Location, ByHeart Whole Nutrition Infant Formula, 24 oz tub

ByHeart Whole Nutrition Infant Formula package with 14/0.6 oz packets

ByHeart Whole Nutrition Infant Formula package with 14/0.6 oz packets

Code information, ByHeart Whole Nutrition Infant Formula package with 14/0.6 oz packets

Code information, ByHeart Whole Nutrition Infant Formula package with 14/0.6 oz packets

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97959
Status: Active
Manufacturer: ByHeart, INC.
Sold By: Sam's Club; Amazon
Manufactured In: United States
Units Affected: 3,482,131 Cans and 3,531,901 Single Serve Packets.
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท FDA Press Release ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.