A powdered infant formula recalled in May is more dangerous than initially thought, the U.S. Food and Drug Administration announced.

Following the May 31 voluntary recall of Crecelac Infant Powdered Goat Milk Formula, further testing revealed elevated levels of certain nutrients that could pose serious health risks to infants.

The powdered baby formula involved in the recall includes:

  • Crecelac infant Powdered Goat-Milk Infant Formula with Iron 0 to 12 months – Net Wt. 12.4 oz (352g), UPC: 8 50042 40847 6, Expiration Dates: 08/2025; 09/2025
  • Farmalac Baby Powdered Infant Formula with Iron 0 to 12 months Net Wt. 12.4 oz (352g), UPC: 8 50042 40841 4, Expiration Dates: 08/2025; 09/2025
  • Farmalac Baby Powdered Infant Formula with Iron Low Lactose 0 to 12 months Net Wt. 12.4 oz (352g), UPC: 8 50042 40839 1, Expiration Dates: 08/2025; 09/2025

“After conducting an abbreviated nutrient analysis of Crecelac Infant Powdered Goat Milk Infant Formula, the FDA found both elevated levels of potassium and chloride and low levels of Vitamin A,” the agency wrote in a July 31 statement.

“The potassium and chloride levels were significantly above the levels permitted in infant formula in the U.S. and could lead to kidney and/or heart problems if the infant formula is used for an extended period of time. In addition, low Vitamin A intake could lead to vision loss from a Vitamin A deficiency if the infant formula is used for an extended period of time.”

The FDA urges families to stop using the baby formula to avoid potential health issues and return it for a full refund.

Cronobacter Contamination Discovered in Crecelac Formula

The FDA issued a non-compliance alert in May for these Mexican-made formulas. Imported by Dairy Manufacturers Inc., of Prosper, Texas, the company sold these products in the United States without the agency’s approval.

Following this alert, the manufacturer voluntarily recalled the three products.

“We sincerely apologize for any inconvenience or concern this may cause and assure our customers that we are taking all necessary steps to ensure the safety, quality, and compliance of our products,” Dairy Manufacturers wrote in a press release announcing the recall.

A little over a week later, the FDA issued a second alert, warning of contamination in the Crecelac infant Powdered Goat-Milk Infant Formula.

During sample testing, the FDA found Cronobacter contamination in the formula.

Testing of the Farmalac formulas did not show any contamination, according to the FDA.

Retail stores sold these products in Texas between March and May.

Dangers of Cronobacter

Cronobacter is a bacterium known to cause severe infections, including sepsis and meningitis.

“Complications from Cronobacter infection in infants can include brain abscess, developmental delays, motor impairments, and death,” the FDA wrote in its safety warning.

Recent concerns over Cronobacter contamination have triggered multiple recalls of infant formula products.

In 2022, Abbott Laboratories issued a major recall of its formula after several Cronobacter infections were linked to its products. This recall, combined with other supply chain disruptions, contributed to a nationwide baby formula shortage, leaving many parents and caregivers struggling to find safe alternatives for their babies.

Because baby formula is not sterile, the risks associated with using powdered formula include contamination, allergic reactions and gastrointestinal problems. Cow’s milk allergies can also impact premature babies who drink formula derived from bovine. The condition is called necrotizing enterocolitis, or NEC.

Baby Formula Lawsuits

Because of the link between NEC and baby formula, many people have filed baby formula lawsuits. There are 106 cases pending in multidistrict litigation in the Northern District of Illinois.

Juries have recently awarded multimillion-dollar payouts to families whose babies died as a result of NEC.

In July, a Missouri jury awarded $495 million to a parent whose premature baby developed irreversible neurological damage after consuming Abbott’s premature infant formula in the neonatal intensive care unit. Abbott vowed to fight the verdict.

In March, a jury in Illinois awarded a mother $60 million after her premature infant died from NEC after using Enfamil.

Those were two state cases that are not part of the MDL. Bellwether trials in the MDL are anticipated to begin in May 2025. Lawyers are still taking on baby formula necrotizing enterocolitis lawsuits.

Editor Lindsay Donaldson contributed to this article.