Recalled Crecelac Formula May Carry Cronobacter Contamination Risk, FDA Warns

Warning comes after FDA took intense criticism for not responding quickly enough to a similar problem with cronobacter in Similac infant formula in 2022, which sickened babies nationwide

Federal food safety officials indicate that recent testing of recalled Crecelac infant formula suggests that the products may carry a risk of potentially dangerous cronobacter infections for babies, which is the same bacteria that caused severe illnesses among infants fed Similac formula several years ago.

The U.S Food and Drug Administration (FDA) issued a Crecelac cronobacter safety alert on June 3, expanding a recently announced recall of the infant formula products after a sample from a retail store in Texas tested positive for cronobacter on May 29.

Cronobacter is a bacterium that can lead to bloodstream infections like sepsis and central nervous system infections like meningitis. In infants, complications from a cronobacter infection can include brain abscesses, developmental delays, motor impairments, and even death. Symptoms of cronobacter infection in infants may include poor feeding, irritability, temperature fluctuations, jaundice, grunting breaths, and abnormal body movements.

In 2022, cronobacter was found in recalled Similac infant formula, which was linked to dozens of reports involving severe illnesses and baby formula lawsuits filed by families throughout the U.S.

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Premature infants fed Similac or Enfamil cow's milk formula face an increased risk of necrotizing enterocolitis (NEC) or wrongful death.

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This new warning follows a Crecelac infant formula recall initially issued on May 25, along with other infant formula products imported and distributed by Dairy Manufacturers Inc., due to the products failing to comply with the FDA’s infant formula regulations. The formula was sold in the U.S illegally because the manufacturer failed to submit the required premarket notification to the FDA.

The recall included Crecelac 12.4 oz containers sold in cardboard and aluminum cans, which were were mainly distributed in March, April, and May of 2024 through retail stores in Texas.

However, that recall was expanded to include Crecelac Infant 0-12, with a UPC of 8 50042 40847 6, lot code 24 039 1 CHE 352-1, and an expiration date of August 2025, after a sample tested positive for cronobacter. It can be identified by the batch code on the bottom of the can.

Consumers who have purchased Crecelac Infant 0-12 should stop using the recalled product and return it to the place of purchase for a full refund, the FDA warns. Those who have concerns about an injury or illness should contact a healthcare provider.

Consumers with questions can reach the company at 1-972-347-2341, Monday to Friday, from 9:30 a.m. to 5 p.m. EST.

2024 Similac Recall Lawsuit Update

The recall comes as the FDA has taken a closer look at the risks of infant formula contamination after similar problems led to a major Similac recall in 2022, when it was revealed that the powdered infant formula had been widely distributed with cronobacter and salmonella bacteria. The FDA faced sharp criticism over the following months, when it was discovered that the manufacturer had been aware of the contamination issues for months before the recall was announced, but was able to continue distributing the products.

More than 80 Similac food poisoning lawsuits have been filed by parents of children diagnosed with various injuries after consuming the recalled infant formula, alleging that Abbott Laboratories neglected safety standards for profit.

Given common allegations raised in complaints being pursued throughout the federal court system, all lawsuits over the Similac recall have been centralized before U.S. District Judge Matthew F. Kennelly in the Northern District of Illinois for coordinated discovery and pretrial proceedings. To help the parties evaluate the strengths and weaknesses of claims, Judge Kennelly has established a Similac lawsuit bellwether trial process, where the parties are focusing on preparing a small number of representative claims to go before juries.

While the outcome of these bellwether trials will not be binding on other cases, they will likely have a big impact on the average Similac recall settlement amounts the manufacturer may have to pay to avoid dozens of individual claims being set for trial in the coming years.

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