The FDA is investigating the spike in infant botulism cases that started in August. The cases have been linked to ByHeart Inc., a baby nutrition company based in the U.S. The company has now expanded its product recall.
Product Recall Issued by ByHeart Inc. Expands
On November 11, 2025, ByHeart Inc., in collaboration with the U.S. Food and Drug Administration (FDA), broadened its product recall. An infant botulism outbreak in August was traced to ByHeart’s infant formula products. The FDA has been investigating the root cause of this outbreak, while the company has expanded its product recall.
Infant botulism is a rare but serious illness that requires immediate medical care. It occurs when infants ingest Clostridium botulinum spores. The spores grow in an infant’s intestinal tract and release toxins that affect the nervous system.
Affected infants show symptoms such as constipation, poor feeding, ptosis, sluggish pupils, low muscle tone, respiratory difficulties, and other signs. Since August, 84 cases of infant botulism have been reported nationwide, several of which have been linked to ByHeart products. The company is now cooperating with the FDA while investigations continue.
Company’s Actions to Safeguard Public Health
Following the outbreak, the FDA and CDC launched a joint investigation into its cause. They found a link between the cases and ByHeart products. The company was quickly notified and moved to expand its recall.
While no unopened ByHeart products tested positive for Clostridium botulinum spores or toxins, the company continues to cooperate with the investigation. The company is recalling all batches of its infant formula currently on the market and conducting additional safety tests. ByHeart has granted FDA and California health officials full access to its facilities and product inventory for testing.
The company is partnering with an independent lab to verify the safety of its formula batches. It is also sharing results from both regulatory and independent testing publicly.
Description of Recalled Products
Heart has expanded its voluntary recall to include all batches of its Whole Nutrition Infant Formula cans and Anywhere Packs. The nationwide recall urges consumers to stop using the formula and dispose of it immediately.
The ByHeart Whole Nutrition Infant Formula can’s UPC is 85004496800, while the Anywhere Pack UPC is 85004496802. Parents with questions regarding the recall may contact ByHeart experts at [email protected] or call their 24/7 line 1 (833) 429-4327.
