Select Lots of ByHeart Infant Formula Recalled due to Potential Botulism

WASHINGTON STATE – The WA State Dept. of Health announces infant formula recall. ByHeart baby nutrition company is recalling select lots of infant formula due to linkage to several cases of infant botulism. The recalled products were produced in April and May and distributed primarily in July and August. The following products are subject to recall:

Product Description:
ByHeart Whole Nutrition Infant Formula

  • Lot 251261P2
  • Lot 251131P2

Use by Date:
01 Dec 2026

By Heart Formula
ByHeart Formula

By Heart

Product Distribution
According to the company’s website, ByHeart Whole Nutrition Infant Formula was sold nationwide through their website and several national retailers such as Amazon, Kroger, Walmart, Whole Foods, and Target. The product was widely distributed in Washington.

Associated Illnesses
As of November 8, multiple illnesses have been reported in connection with the recalled products, including 13 hospitalizations across 10 states.

Infant botulism occurs when spores of C. botulinum bacteria are swallowed and grow inside the intestines. Unlike foodborne botulism, where toxin is eaten in contaminated food, this type of botulism develops inside the body. It most often affects babies under 1 year old – or others with immature or weekend intestinal defenses – after exposure to an environmental source such as dust, soil, or honey.

Signs and symptoms of infant botulism include constipation, poor feeding, loss of head control, difficulty swallowing, or decreased facial expression. Symptoms of infant botulism can take several weeks to develop and can cause life-threatening illness.

Additional Information
The problem was discovered during investigation of several cases of infant botulism in multiple states. For additional information on the recall, see the company announcement on the FDA: In Response to a Broader FDA Investigation, ByHeart Initiates a Voluntary Recall of Two Batches of Infant Formula | FDA

CDC information on the outbreak: Infant Botulism Outbreak Linked to Infant Formula, November 2025 | Botulism | CDC

FDA information on the investigation: Outbreak Investigation of Infant Botulism: Infant Formula (November 2025) | FDA

Consumer Guidance
Parents and caregivers should not use the recalled lots of ByHeart Whole Nutrition Infant Formula and should throw this product away immediately. If your child is experiencing symptoms after consuming ByHeart Whole Nutrition Infant Formula seek immediate health care. If you still have the formula in your home, record the information on the bottom of the package before throwing it away.

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