FDA

ByHeart expands recall of all infant formula amid ongoing FDA-CDC botulism probe

November 13, 2025

In a joint action with the FDA, ByHeart has voluntarily recalled all batches of its Whole Nutrition Infant Formula cans and Anywhere Pack as the agency investigates a multistate spike in infant botulism—84 cases nationally since August, including 15 infants with confirmed or suspected exposure to ByHeart. No unopened products have tested positive for C. botulinum spores or toxin, but an open can linked to illness contained the bacteria. ByHeart is ramping up independent batch testing, granting FDA and CDPH full lab access, and pledging transparency as investigators seek the outbreak’s source

What clinicians should know:

• Monitor for signs: Constipation, poor feeding, hypotonia, weak cry, progressing to respiratory compromise.
• Onset: Symptoms may appear weeks after ingestion.
• Action: Prompt hospitalization and antitoxin therapy are critical; report suspected cases to local health authorities.

Source:

(2025, November 11). FDA. ByHeart Broadens Voluntary Recall While Investigation Continues. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/byheart-broadens-voluntary-recall-while-investigation-continues