FDA warns Walmart, Target, Kroger and Albertsons over failure to pull recalled ByHeart formula
A botulism outbreak tied to ByHeart infant formula has sickened 51 babies in 19 states, and the FDA says it "cannot rule out" contamination across all ByHeart formula produced since March 2022; ByHeart says it is cooperating and had roughly 1% of the U.S. formula market (about 200,000 cans sold per month) before the recall. On Dec. 12 the FDA warned Walmart, Target, Kroger and Albertsons for continuing to offer recalled ByHeart products after the recall—finding the formula at Target in 20 states, Walmart in 21, Albertsons in 11 and Kroger in 10, citing sales despite electronic blocks and promotional activity—and gave the retailers 15 working days to respond while retailers say they removed and blocked affected products.
📌 Key Facts
- The botulism outbreak tied to ByHeart infant formula includes 51 infants across 19 states; California has at least nine cases and Texas seven or eight. Twelve additional cases were identified after an expanded case definition (two within the original timeline and 10 from Dec. 2023 through July 2025); the most recent reported illness occurred Dec. 1, 2025.
- The FDA issued Dec. 12 warning letters to Walmart, Target, Kroger and Albertsons for continuing to offer recalled ByHeart infant formula after the recall.
- FDA store-level findings showed post-recall ByHeart formula present in stores in multiple states: Target in 20 states, Walmart in 21, Albertsons in 11 and Kroger in 10; FDA reported specific incidents at Target, including sales in New Hampshire on Nov. 16 despite an electronic block and promotion of single‑serve packs in Arkansas from Nov. 16–22.
- The FDA said the retailers have not provided evidence of corrective actions and have 15 working days to respond to the warning letters.
- Walmart and Albertsons issued statements saying they removed recalled ByHeart products and blocked sales at registers after the recall.
- The FDA and CDC say they "cannot rule out" contamination across all ByHeart formula produced since March 2022; ByHeart says it is cooperating with investigators to determine the root cause.
- ByHeart’s market footprint before the recall was small but nontrivial: roughly 1% of the U.S. infant formula market, with about 200,000 cans sold per month.
- The Association of Food and Drug Officials (AFDO) criticized the FDA for a delay in distributing complete product lists to retailers and regulators, saying the lists were not fully shared until Nov. 14—nearly a week after the initial Nov. 8 recall.
📰 Sources (3)
Retailers didn't pull ByHeart baby formula fast enough after botulism recall, FDA says
New information:
- FDA issued Dec. 12 warning letters to Walmart, Target, Kroger and Albertsons for continuing to offer recalled ByHeart infant formula after the recall.
- FDA cited store-level findings: Target had sales in New Hampshire on Nov. 16 despite an electronic block, promoted single-serve packs in Arkansas Nov. 16–22; ByHeart formula was found post-recall at Target in 20 states, Walmart in 21, Albertsons in 11, and Kroger in 10.
- FDA says retailers have not provided evidence of corrective actions; companies have 15 working days to respond.
- Walmart and Albertsons issued statements asserting they removed products and blocked sales; Walmart said registers were blocked after the recall.
- AFDO’s Steven Mandernach criticized FDA for slow distribution of complete product lists (not fully shared until Nov. 14), nearly a week after the initial Nov. 8 recall.
Botulism outbreak tied to ByHeart products includes 51 babies in 19 states
New information:
- FDA/CDC list the 19 affected states and note California has at least nine cases and Texas has seven or eight.
- Breakout of added cases: 12 additional cases identified via the expanded definition (two within the original timeline and 10 from Dec. 2023 through July 2025).
- Confirms the most recent reported illness occurred on Dec. 1, 2025.
- ByHeart’s market footprint before the recall: roughly 1% of U.S. formula market and about 200,000 cans sold per month.
- Reiterates FDA’s position that it "cannot rule out" contamination across all ByHeart formula produced since March 2022 and includes ByHeart’s statement that it is cooperating to determine root cause.