ByHeart Infant Formula Recalled Amid Infant Botulism Outbreak

Federal and state health officials are investigating an outbreak of infant botulism linked to ByHeart brand powdered formula. As of November 8, 13 confirmed cases have been reported across 10 U.S. states, with no fatalities. The FDA recommended a recall, and ByHeart has voluntarily withdrawn two lots of its Whole Nutrition Infant Formula — Lot 206VABP/251261P2 and Lot 206VABP/251131P2, both marked “Use by 01 Dec 2026.” Tests by the California Department of Public Health confirmed the presence of botulism in samples. Health authorities urge parents to stop using the product immediately and discard it. Infant botulism, though rare, can cause muscle weakness, feeding difficulties, and respiratory failure if untreated. The FDA, state agencies, and the Infant Botulism Treatment and Prevention Program continue testing formula samples. Consumers are advised to seek immediate medical care if infants show symptoms and report product details before disposal.

11-11-2025