ByHeart Infant Formula Recall and FDA Compliance Issues

ByHeart Inc. has recalled two lots of its Whole Nutrition Infant Formula following botulism contamination linked to 13 infant cases across 10 U.S. states. The FDA and California health officials confirmed the presence of botulism toxin in the formula, advising consumers to discontinue its use immediately. This is not the company’s first safety issue—its 2022 recall involved Cronobacter contamination, and a 2023 FDA warning cited unsanitary production conditions. The FDA inspection revealed multiple violations, including inadequate process controls, poor sanitation practices, and ineffective root cause analyses following contamination events. The agency criticized ByHeart for releasing product batches that tested positive for Cronobacter and failing to address environmental factors, such as facility leaks, that contributed to bacterial growth. ByHeart’s handling of contaminated products violated federal manufacturing standards, prompting the FDA to intensify oversight of its operations and emphasize stricter adherence to infant formula safety regulations.

12-11-2025