FDA warns Walmart, Target, Kroger and Albertsons over failure to pull recalled ByHeart formula
On Dec. 12 the FDA issued warning letters to Walmart, Target, Kroger and Albertsons after finding recalled ByHeart infant formula still being sold or present at store level — Target in 20 states, Walmart in 21, Albertsons in 11 and Kroger in 10 — and gave each retailer 15 working days to respond with evidence of corrective actions. Walmart and Albertsons said they removed products and implemented point-of-sale blocks while Target and Kroger were contacted for comment, and AFDO criticized the FDA for not sharing complete product lists with state and local officials until Nov. 14. The enforcement action comes as the CDC has expanded the outbreak definition to all ByHeart formula produced since 2023, which has hospitalized about 51 infants in 19 states, and the FDA said it had not received reports of recalled product on shelves since Nov. 26.
📌 Key Facts
- The FDA issued Dec. 12 warning letters to Walmart, Target, Kroger and Albertsons for continuing to offer recalled ByHeart infant formula; the letters were posted online and the retailers have 15 working days to respond and provide evidence of corrective actions.
- FDA store-level findings show recalled ByHeart formula was found post-recall at Target in 20 states, Walmart in 21, Albertsons in 11 and Kroger in 10; the agency cited specific instances such as Target sales in New Hampshire on Nov. 16 despite an electronic block and promotion of single-serve packs in Arkansas Nov. 16–22.
- Retailer responses: Walmart and Albertsons said they removed products and blocked sales/registers after the recall; Target and Kroger were contacted for comment.
- The FDA reported it had not received reports of recalled ByHeart formula on store shelves since Nov. 26, 2025.
- The CDC expanded the outbreak definition to include all infants treated for botulism after consuming ByHeart formula since production began; all affected babies were hospitalized and treated with antitoxin. The investigation now includes 51 infants across 19 states (California at least nine cases; Texas seven or eight), with 12 additional cases identified under the expanded definition and the most recent reported illness on Dec. 1, 2025.
- ByHeart’s market footprint before the recall was relatively small — roughly 1% of the U.S. infant formula market, about 200,000 cans sold per month.
- The FDA has said it “cannot rule out” contamination across all ByHeart formula produced since March 2022; ByHeart says it is cooperating with authorities to determine the root cause.
- The Association of Food and Drug Officials’ Steven Mandernach criticized the FDA’s recall communications, saying full product lists were not shared with state and local officials until Nov. 14, nearly a week after the initial Nov. 8 recall.
📰 Sources (4)
FDA warns 4 major retailers about selling recalled ByHeart infant formula
New information:
- FDA says it has not received reports of recalled ByHeart formula on store shelves since Nov. 26, 2025.
- CDC has expanded the outbreak definition to include all infants treated for botulism after consuming ByHeart formula since production began in 2023; all affected babies were hospitalized and treated with antitoxin.
- AFDO’s Steven Mandernach criticized FDA’s recall communications, saying the agency didn’t fully share product lists with state/local officials until Nov. 14, nearly a week after the initial Nov. 8 recall of two lots.
- Retailer responses: Walmart said no ByHeart sales occurred after POS blocks; Albertsons said products were removed and customers notified; Target and Kroger were contacted for comment.
- FDA letters were posted online Monday, reiterating companies have 15 working days to respond and to provide evidence of corrective actions.
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.