The FDA has sent warning letters to four major grocery chains after a multi-state recall of ByHeart infant formula linked to a deadly botulism outbreak left 51 infants sick across 19 states.
FDA Warning Letters Sent to Target, Walmart, Albertsons and Kroger
The letters, issued on Friday, state that despite the recall, the products remained available for purchase on shelves through at least November and “well after the recall was initiated and expanded,” even after multiple notifications. Each letter tells retailers: “As a participant in the supply chain, your firm should take prompt and effective action when notified of a product recall.” It adds: “Once your firm has been made aware of a recall or potential safety issue, you should take action to immediately remove the affected product from distribution and sale, cease all further shipment or use, and implement all necessary measures to prevent further exposure to consumers or downstream distribution.”
Recall Details and Impact on Supply
The recall began in August and involves ByHeart Whole Nutrition Infant Formula. According to the Centers for Disease Control and Prevention, at least 51 infants across 19 states developed botulism after being fed the recalled formula, and the investigation remains ongoing. ByHeart’s formula represents less than 1% of all infant formula sold in the U.S., and the FDA says the recall is not expected to affect nationwide supply or contribute to a formula shortage.
FDA Findings in Retail Stores
- Target: The recalled products remained on shelves in at least 20 Target stores. In one instance, single-serve packs were marked with a promotional “Sale!” sign. State and local partners reported several explanations offered by Target store associates for the continued presence of the recalled product, including lack of awareness of the recall notice, confusion regarding which specific lots were affected, failure to remove all impacted product, and stocking products that arrived after the recall notification.
- Albertsons: The tainted formula was found on shelves at Albertsons stores across 11 states, including Jewel-Osco grocery stores.
- Walmart: Products were on shelves across 21 states.
- Kroger: Products were on shelves at Kroger-owned stores across 10 states.
Retailer Responses
Albertsons issued a statement to NBC Chicago saying: “At Albertsons Companies, we are committed to the health and safety of our customers,” the statement read. “We have procedures to address product recalls, including working closely with suppliers and regulators to identify and remove affected items and communicate guidance to customers.” Target, Walmart and Kroger did not immediately respond to NBC Chicago’s request for comment.
Infant Botulism Overview
Infant botulism is a rare but serious illness caused by Clostridium botulinum bacteria. Symptoms may include:
- Constipation
- Poor feeding
- Drooping eyelids
- Sluggish pupils
- Low muscle tone
- Difficulty sucking or swallowing
- Weak or altered cry
- Generalized weakness
- Respiratory difficulty or arrest
The FDA warns that infant botulism can be fatal if not treated promptly.
FDA Calls for Action
The letter advises the stores to contact the FDA in writing within 15 days, detailing the steps taken to address the violations.
Current Investigation and Other Brands
Since August, the FDA has received 83 reports of botulism potentially tied to infant formula. NBC Chicago has asked the agency for the names of other brands involved, but no additional information has been released.
Key Takeaways
- The FDA has warned Target, Walmart, Albertsons, and Kroger that recalled ByHeart formula remained on shelves through November.
- 51 infants in 19 states have been affected by botulism linked to the recalled formula.
- Retailers must act promptly to remove recalled products and report their actions to the FDA within 15 days.
The recall underscores the importance of swift action by retailers when notified of product safety issues, and the FDA’s oversight continues as the investigation into the outbreak progresses.
