FDA Issues Warning on Contaminated Infant Formula from Texas Producer

US health authorities have issued a warning to parents regarding the use of powdered infant formula from a Texas-based dairy producer, following the discovery of a harmful bacteria in one of the company's products. The alert, released by the Food and Drug Administration (FDA) on Friday, specifically targets the Crecelac Infant Powdered Goat Milk Infant Formula. This action comes after a sample from a Texas store tested positive for cronobacter, a bacterium capable of causing fatal infections in infants. This incident echoes the 2022 recalls and shortages triggered by the detection of cronobacter at a significant US formula manufacturing facility.

The implicated Crecelac formula, imported and distributed by Dairy Manufacturers Inc., located in Prosper, Texas, has led to concerns due to its potential distribution breadth across the US. However, details regarding the production location or the extent of its US distribution remain unspecified by both the FDA and Dairy Manufacturers Inc. Attempts to contact the company for comments have so far been unanswered.

In response to these findings, Dairy Manufacturers Inc. has voluntarily recalled not only the Crecelac brand but also another product line named Farmalac, citing lack of FDA approval for sale within the United States. The FDA mandates that infant formula distributors demonstrate compliance with US food and nutritional standards through data submission. While subsequent tests on Farmalac did not reveal cronobacter presence, authorities are advising against its use as a precaution.

Cronobacter infections can lead to severe health issues in infants, including blood infections, meningitis, and damage to the nervous system. These bacteria are naturally occurring in the environment but pose a risk to infants when they contaminate infant formula packages after opening.

The discovery of cronobacter at an Abbott formula plant in Sturgis, Michigan, in 2022 resulted in its closure by FDA investigators. The shutdown was initiated following inspections linked to four infant illnesses related to cronobacter exposure, including two fatalities, revealing widespread contamination. The resultant formula shortages prompted the FDA to permit imports from foreign manufacturers, a shift from its previous policy that limited production to domestic companies like Abbott.