Picture from FDA
Certain retailers left ByHeart formula on store shelves. Despite major publicity of the ongoing Infant Botulism outbreak linked to the product. Regulators repeatedly noted that four retailers ignored the recall notices leaving consumers and babies at risk.
Target Corporation, The Albertsons Companies Incorporated, The Kroger Company, and Walmart, Inc received US Food and Drug Administration (FDA) Warning Letters from the Human Foods Program for these lapses and violations of inadequate response to the “receipt and offer of adulterated foods.”
Here’s what we know about the FDA Warning Letters sent to retailers for keeping ByHeart formula on store shelves.
News of an infant botulism outbreak began making its way through outbreak investigation channels in November 2025. The FDA, in collaboration with the Centers for Disease Control and Prevention (CDC), the California Department of Public Health (CDPH), Infant Botulism Treatment and Prevention Program (IBTPP), along with state and local partners across the country began investigating a multistate outbreak of infant botulism.
ByHeart Whole Nutrition infant formula was a common factor in these cases.
As of December 10, 2025, at least 51 infants across 19 states have suspected or confirmed infant botulism. All 51 infants have been hospitalized.
Based on available data, a common food source was identified.
ByHeart Whole Nutrition infant formula.
In response to finding Clostridium botulinum in ByHeart infant formula products and the growing number of sick infants who consumed the product, a voluntary recall was initiated.
A recall notice was published and sent (in writing) to retailers and resellers who have purchased the product through wholesale channels. “Consignees” of the recalled products.
This recall notice indicated the specific lots of ByHeart infant formula subject to recall and noted the products that should be pulled from consumer access.
Days later, on November 11, another notice sent (in writing) indicated that the recall had expanded to include more ByHeart formula products/lots.
All ByHeart Whole Nutrition infant formula (including all unexpired lots of formula cans and single-serve “anywhere pack” sticks were recalled.
If it says ByHeart, it was officially recalled.
ByHeart did their part. They conceded to a voluntary recall and made their announcement. The FDA did their part. All “consignees” with product were sent written notice of the scope of the recall.
Target, Albertsons, Kroger, and Walmart dropped the ball.
The FDA issued Warning Letters Target Corporation, The Albertsons Companies Incorporated (which includes Albertson’s, Start Market, Jewel-Osco, Acme, Safeway, and Shaw’s stores), The Kroger Company, and Walmart, Inc. by electronic mail on December 12, 2025 and published those letters to a public forum on December 15, 2025.
These letters revealed repeated opportunities to follow regulations and recall practices that these firms ignored. Allowing consumers access to these potentially tainted products after recalls are publicly announced is confusing. Consumers may incorrectly assume that offered product was not included in the recall and put their child at risk.
To make matters worse, direct communication with these stores were still unsuccessful. After calls and letters with officials in the companies, these retailers left ByHeart formula on store shelves.
According to the Warning Letter, the retailer left ByHeart formula on store shelves “in at least [redacted] Target stores across 20 states well after the recall was initiated and subsequently expanded.”
The FDA states that despite Target notifying the FDA on November 19, 2025 that an “electronic block” was placed on the SKU for cans of recalled ByHeart infant formula on the recall dates, an audit proved otherwise.
On November 17, 2025 an FDA investigator noted that a can of recalled product was sold the previous day at a New Hampshire Target store. State and local partners also noted ByHeart formula on store shelves.
The FDA determined that recalled product remained available to the public in 20 states between November 12 to November 20, 2025.
A store in Arkansas was even found to display promotional signage and coupons for the recalled formula between November 16 and November 22, 2025 according to state partners.
According to the Warning Letter, regulators noted that recalled ByHeart infant formula “remained available for purchase on shelves at [redacted] Albertsons stores, including Albertson’s, Star Market, Jewel-Osco, Acme, Safeway, and Shaw’s, across 11 states well after the recall was initiated and subsequently expanded.”
The FDA determined that recalled product remained available to the public in 11 states between November 12 to November 19, 2025.
According to the Warning Letter, regulators noted that recalled ByHeart infant formula “remained available for purchase on shelves at [redacted] Kroger stores, including Kroger’s, King Sooper’s, and Smith’s, across 10 states well after the recall was initiated and subsequently expanded.”
The FDA determined that recalled product remained available to the public in 10 states between November 12 to November 19, 2025.
According to the Warning Letter, regulators noted that recalled ByHeart infant formula “remained on shelves at [redacted] Walmart store locations across 21 states.”
The FDA determined that recalled product remained available to the public in 10 states between November 12 to November 19, 2025.
Initial excuses from associates at all four companies included:
A call, followed by multiple emails that have requested a corrective action plans from all four retailers. Corrective actions have not been provided.
The FDA issues warning letters to serve as an official notification. In addition to notifying the company directly, this information is made available to the public.
According to the agency, a warning letter is issued “when the FDA finds that a manufacturer has significantly violated FDA regulations.”
Common reasons for a warning letter include:
In this case, a violation of FDA requirements. Failure to remove ByHeart formula from store shelves falls under “the receipt in interstate commerce of adulterated food, and the delivery or proffered delivery thereof.” A violation of section 301(c) of the FD&C Act [21 U.S.C. § 331(c)].
These warning letters are not the first form of communication. They often result from repeated violations or failure to correct FDA complaints.
Once a warning letter is issued, the firm has 15 days to satisfactorily respond. If that compliance is not met, additional FDA actions may occur. Up to, but not limited to requiring the facility to close.
So, what happens next?
For now, these Warning Letters serve as a slap on the wrist. A notification that these companies will be more closely monitored.
Per the Warning Letter, each company must respond “satisfactorily.” At a minimum it will include an updated recall management plan. Plus planned employee training and other corrective actions to ensure this does not happen again.
If you child has been impacted by infant botulism after consuming ByHeart infant formula, it is a good idea to get legal advice. A Food Poisoning Lawyer understands product contamination and product liability cases and can help you through this difficult process.
The experienced Food Poisoning Lawyers at The Lange Law Firm, PLLC are dedicated to holding food companies accountable for lapses in food safety that result in illness or injury. They have recovered millions of dollars in product liability and food poisoning cases.
They can help you too!
Call (833) 330-3663 for a free, no obligation consultation. Or fill out the online submission form, and someone will get back with you right away.
By Heather Van Tassell (contributing writer, non-lawyer)
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