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Target left botulism-linked infant formula on store shelves, FDA says

The exterior of a Target store.
Target stores, including in California, received a warning letter after leaving botulism-linked infant formula on shelves despite a recall. Above, a shopper visits a Target in Salem, N.H.
(Charles Krupa / Associated Press)
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  • Target failed to remove ByHeart infant formula from shelves despite U.S. Food and Drug Administration recall notices, with the contaminated product remaining available in 20 states through mid-November.
  • The recalled formula is linked to a multistate botulism outbreak that has hospitalized 51 infants across 19 states, with no deaths reported to date.
  • The FDA sent warning letters to Target and three other major retailers; Target blamed lack of staff awareness and confusion about which product lots were affected.

Infant formula that could have been tainted with botulism remained on Target shelves after a recall, according to federal officials.

The chain store failed to quickly remove the recalled formula, ByHeart — linked to a nationwide botulism outbreak — from its retail locations in several states including California, the U.S. Food and Drug Administration says.

To date, the outbreak has led to the hospitalization of 51 infants. No deaths have been reported.

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On Monday, the FDA announced that it sent warning letters to four of the nation’s top retail stores — Target, Walmart, Kroger and Albertsons — when the companies hadn’t removed ByHeart from their stores in certain states despite being notified of the recall.

Target was the only company of the four that hadn’t removed the recalled product from its stores in California.

ByHeart Inc. initiated a voluntary recall of ByHeart Whole Nutrition Infant Formula on Nov. 8, and three days later, the company expanded the recall to include all unexpired lots of formula cans and single-serve “anywhere pack” sticks. Target was directly notified of both recall notices, according to the FDA.

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In response, the warning letter states, Target said it placed an electronic block on the SKU for the recalled products on the day of the first recall notice and again with the second recall notice.

However, subsequent visits by FDA regulators confirmed that the recalled products remained available for purchase in Target’s retail locations across 20 states, including California, from Nov. 12 through 20, according to the warning letter.

According to those investigating, store associates said the recalled product was still on shelves because of “a 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.”

As of Dec. 12, Target had not provided the FDA with any information demonstrating that corrective actions had been taken.

The store responded in a statement to The Times: “Following the national recall of ByHeart products, Target immediately notified guests, initiated refunds and began removing all ByHeart Whole Nutrition Infant formula products from shelves and online, and we have engaged a systematic lock to prevent purchase at point of sale.”

As of Dec. 10, reports of cases linked to the infant botulism outbreak had slowed, and public health officials have not added any new cases to this investigation.

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Illnesses were reported as far back as Dec. 24, 2023, and as recently as Dec. 1 of this year. Laboratory confirmation for some cases is ongoing.

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