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.
Contaminated with Clostridium botulinum
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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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.
Clostridium botulinum can cause severe illness or death, particularly in infants. This bacterium produces toxins that can lead to respiratory failure or paralysis. The recall falls under Class I, indicating a high hazard level.
To date, no injuries or illnesses have been reported related to this recall. The high hazard classification reflects the potential for serious health consequences.
Consumers should stop using the recalled products immediately. Contact ByHeart, Inc. for refund or replacement information through email, fax, letter, press release, or telephone.
For more information, visit the ByHeart recall webpage or call the company directly. Additional resources are available through the FDA website.
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