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FDA Issues Safety Alert on 4 Baby Formula Products

By Tom Marino | June 3, 2024
Last Updated: June 3, 2024

WASHINGTON – The U.S. Food and Drug Administration (FDA) has issued a safety alert for parents, guardians, and caregivers about the recall of three baby formula products about potential exposure to the bacterium Cronobacter. The bacterium can cause bloodstream and central nervous system infections, such as sepsis and meningitis.

Complications for infants exposed to the bacterium can include brain abscess, developmental delays, motor impairments, and death. Symptoms may include poor feeding, irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.

The three products, made Dairy Manufacturers Inc., are:

  • CRECELAC INFANT Powdered Goat-Milk Infant Formula with Iron 0 to 12 months – Net Wt. 12.4 oz (352g)
  • Farmalac BABY Powdered Infant Formula with Iron 0 to 12 months Net Wt. 12.4 oz (352g)
  • Farmalac BABY Powdered Infant Formula with Iron Low Lactose 0 to 12 months Net Wt. 12.4 oz (352g)

Dairy Manufacturers Inc. initiated the recall on May 24. According to the FDA, the products did not comply with all the FDA’s infant formula regulations. The FDA investigation found Cronobacter in a sample of Crecelac Infant Powdered Goat Milk Infant Formula collected from a retail store in Texas.

The products are prominent in Texas, but distributed to locations across the country.

The FDA says that the company did not submit the required pre-market notification to the FDA, making the sale of the products illegal. As of Friday, May 31, the FDA reported it was not aware of any illness associated with these products.

In 2022, a large product recall of baby formula followed two babies who allegedly died after consuming Abbott Infant Formula. The recall led to a severe shortage of baby formula.

The FDA also said it does not expect any effect on the overall supply of infant formula because of this recall.

See the labels of the affected formula products below:

Farmalac BABY Powdered Infant Formula with Iron Low Lactose 0 to 12 months Net Wt. 12.4 oz (352g) Farmalac BABY Powdered Infant Formula with Iron 0 to 12 months Net Wt. 12.4 oz (352g) CRECELAC INFANT Powdered Goat-Milk Infant Formula with Iron 0 to 12 months - Net Wt. 12.4 oz (352g) second label CRECELAC INFANT Powdered Goat-Milk Infant Formula with Iron 0 to 12 months - Net Wt. 12.4 oz (352g) first label

The FDA’s alert is available on its website.

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