Recalled Baby Formula Tied to Botulism Outbreak Still Sold at Major Retailers, FDA Says

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ByHeart Infant Formula Recall Expands After Botulism Bacteria Found in
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Federal regulators have issued warning letters to four of the nation's largest retailers after investigators found recalled ByHeart infant formula tied to a botulism outbreak still being sold in stores.

Walmart, Target, Kroger, and Albertsons were flagged for continuing to offer the formula weeks after a nationwide recall, according to the Food and Drug Administration (FDA).

According to Bloomberg, the recalled ByHeart Whole Nutrition Infant Formula has been linked to 51 cases of infant botulism across 19 states.

The rare but potentially fatal illness occurs when babies ingest spores of Clostridium botulinum, which can grow in the immature gut and produce dangerous toxins. Affected infants ranged in age from 16 to 264 days.

ByHeart first initiated a voluntary recall of certain lots on November 8, 2025, and expanded the recall on November 11 to include all of its infant formula products, including cans and single-serve "anywhere packs."

Despite repeated recall notices and follow-up warnings from the FDA, inspectors and state health officials later found the recalled formula still available for sale.

At Walmart, recalled products were found on shelves in 21 states from November 12 through November 26, and the company failed to show that corrective measures had been taken despite multiple follow-up communications.

Target stores across 20 states also sold recalled formula between November 12 and November 20, even though the retailer said it had electronically blocked the affected products.

FDA Orders Retailers to Pull Contaminated Baby Formula

Kroger locations, including King Soopers and Smith's, sold recalled formula in 10 states, while Albertsons stores—including Safeway, Jewel-Osco, and Shaw's—continued offering it in 11 states.

FDA officials noted that these failures occurred even after companies were notified of both the initial and expanded recalls.

"At Albertsons Companies, we are committed to the health and safety of our customers," a company spokesperson told The Post.

"ByHeart infant formula products have been removed from our store shelves, and we work closely with suppliers and regulators during recalls."

Infant botulism symptoms can take weeks to appear and include constipation, poor feeding, loss of head control, and difficulty swallowing.

Severe cases can progress to respiratory failure. The FDA, CDC, and state partners continue to test unopened formula samples, cautioning that negative results do not rule out contamination.

The FDA warned all four retailers that failure to correct these violations could lead to seizure, injunction, or other legal actions.

Each company has been given 15 working days to submit a plan to prevent recalled products from being sold in the future.

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