Overview
- Nara Organics voluntarily recalled all U.S. powdered infant formula on June 13 after the FDA and CDC linked three infant botulism cases in Pennsylvania, California and Washington to the company’s products.
- One of the affected infants from Yardley, Pennsylvania, was admitted to the Children’s Hospital of Philadelphia on June 1, treated with the BabyBIG antitoxin, discharged on June 6, and is receiving weekly physical therapy for motor delays.
- Nara says none of its products have tested positive so far and that the recall was issued out of an abundance of caution, while public‑health laboratories are testing unopened and returned cans and expect results in the coming weeks.
- The federal lawsuit filed by the Goldfin family alleges Nara failed to test directly for Clostridium botulinum, made misleading safety and FDA‑related marketing claims, and names both Nara and Target as defendants.
- This cluster follows a recent ByHeart whole‑milk formula outbreak and has intensified calls for stronger pre‑market testing, expanded surveillance and clearer manufacturing standards for powdered infant formulas.