⚠️ CRITICAL SAFETY ALERT - RECALLED NOVEMBER 2025 ⚠️
ALL ByHeart infant formula products (cans and single-serve sticks) were recalled starting November 8, 2025. The recall was expanded to ALL products by November 11, 2025.
REASON FOR RECALL: Infant botulism outbreak linked to Clostridium botulinum contamination. As of December 2025, 51+ confirmed cases across 19 states.
ONGOING CONCERNS: The FDA issued warning letters to major retailers (Walmart, Target, Kroger, Albertsons) for slow removal of recalled product. Reports indicate product was still found on shelves into December 2025.
DO NOT PURCHASE OR USE.
If you have ByHeart formula, stop use immediately and contact your pediatrician if your baby has consumed it. Check FDA.gov and CPSC.gov for the latest recall information.
PREVIOUS REVIEW (PRE-RECALL): Before the recall, ByHeart was highly regarded for its whole milk protein and clean ingredient list. The company had positioned itself as a premium clean formula alternative. This recall is a devastating setback for the brand.
THE R3 POSITION: We cannot recommend any recalled product. Even if ByHeart returns to market after addressing the contamination, we would require extensive safety verification before reconsidering.
