Class I — Most Severe

ByHeart Recalls Infant Formula Due to Botulism Risk

FreshRecall Team ByHeart Inc. Botulism

This recall was posted 4 months ago. Check the FDA source for the latest status.

Class I Recall — Most Serious

This is a Class I recall — the most serious type. Products covered by this recall may cause serious health consequences or death.

Reported Health Impact

83

Illnesses

ByHeart infant formula, Net Wt. 24 oz product image Batch Code: 251261P2, Use by: 01 Dec 2026; Batch Code: 251131P2, Use by: 01 Dec 2026 at bottom of can ByHeart Infant formula Back label UPC: 5004496800

ByHeart has announced a voluntary recall of two batches of its Whole Nutrition Infant Formula due to concerns over potential botulism risk. This decision follows an FDA investigation into a recent outbreak of infant botulism.

Affected Products:

  • Batch Code: 251261P2, Use by: 01 Dec 2026
  • Batch Code: 251131P2, Use by: 01 Dec 2026
  • UPC: 5004496800

The batch code and use-by date can be found on the bottom of the can. No other batches are affected.

Reason for Recall:

The recall is a precautionary measure after the FDA reported 83 cases of infant botulism nationwide since August 2025. Although no direct link has been established between the formula and these cases, ByHeart is acting to eliminate any potential risk.

Health Risks:

Infant botulism is a rare but serious illness caused by Clostridium botulinum spores. Symptoms include constipation, poor feeding, drooping eyelids, and respiratory difficulties.

What Consumers Should Do:

  • Stop using the recalled formula immediately and dispose of it.
  • Contact ByHeart for a free replacement if you have discarded any affected formula.
  • If your infant shows symptoms of botulism, seek medical attention immediately.
  • For questions, contact ByHeart at [email protected] or call 1 (833) 429-4327, available 24/7.

ByHeart emphasizes that no contamination has been found in their products, and this recall is a proactive measure to ensure infant safety.

Where Products Were Sold

This recall affects products distributed nationwide across the United States.

Contact Information

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View original FDA announcement