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Texas Infant Formula Manufacturer Updates Recall Due to Infant Formula Contamination

Posted in Outbreaks & Recalls on June 25, 2024

What started out as a recall due to non-compliance with U.S. Food and Drug Administration (FDA) requirements has escalated to an updated recall.  This time for infant formula contamination concerns.

Laboratory reports identified the potentially deadly Cronobacter bacteria in formula product samples.

Dairy Manufacturers Inc Initial Recall Due to Non-Compliance with FDA New Infant Formula Registration Requirements

The initial recall for all lots of Dairy Manufacturers Inc infant formulas was announced on May 24, 2024. This recall was initiated, according to the announcement, because “the products listed were sold in the U.S. without complying with the FDA’s infant formula regulations.”

These products included:

  • Crecelac Infant 0-12
  • Farmalac 0-12
  • Farmalac 0-12 Low Lactose

Among other FDA requirements for minimum and maximum nutritional composition and labeling standards, the FDA has specific “premarket” processes that a company wishing to sell infant formula in the United States must go through.

Section 21 CFR 106.110 requires a premarket notification so that facilities can be inspected, formulas can be assessed, and labels can be approved.

As a result, the product needed to be recalled until approval was given.

Two weeks later, results of product sampling prompted a second recall due to potential infant formula contamination with Cronobacter bacteria.

Recall Updated Following Discovery of Infant Formula Contamination

Dairy Manufacturer Inc., of Prosper, Texas issued an extension to the ongoing recall on June 3, 2024. This time for more than just lapses in filing paperwork.

Product samples tested positive for the potentially deadly bacteria, Cronobacter spp.

The updated recall includes Crecelac Infant 0-12 with an expiration date of 08/2025 that was manufactured at the Dairy Manufacturer Mexican Sa De Cv in Monterey, Mexico.

Recalled Product

Crecelac Infant 0-12

12.4 oz

UPC: 8 50042 40847 6

Lot Code: 039 1 CHE 352-1

Expiration Date: 08/2025

These 12.4 oz containers were primarily distributed to retail stores in the state of Texas during the months of March, April, and May of 2024. Affected products may still be in consumer homes.

Recalled product can be identified by the batch lot code located on the bottom of the cardboard and aluminum can.

Caregivers are Instructed to Discontinue Use of Recalled Product

There have been no reports of illness or adverse reaction due to consumption of this recalled product due to contamination risk or the initial recall so far. However, it can take several weeks for an illness to be linked to a contaminated food product.

If you have used recalled products, you should monitor your child for symptoms of Cronobacter infection. Anyone concerned about illness or injury should contact their healthcare provider and tell them about the potential exposure risk. This will ensure appropriate testing is performed to provide specific treatment if the illness is caused by a Cronobacter infection.

What is Cronobacter?

Cronobacter bacteria can be naturally found in the environment. However, they also like to live in dry goods like herbal teas, starches, and most notably – powdered milk and powdered infant formula.

Cronobacter infections have been reported in all age groups. Infections in infants, however, can be the most dangerous. Particularly those less than 2 months old.

Infants less than 2 months old are more likely to develop a serious brain complication called meningitis when exposed to Cronobacter bacteria. Meningitis presents as an inflammation of the membranes that protect the brain and spine.

Infants born prematurely and those with weakened immune systems are also at risk for severe illness. Cronobacter infections in infants less than 12 months old are often linked to powdered infant formula.

The true number of annual Cronobacter cases is unknown. It wasn’t until this year that invasive Cronobacter infections were added to the list of nationally notifiable conditions. This status requires healthcare providers to report those cases to state or local health officials. Going forward, more information about the true number of Cronobacter cases will be known.

Cronobacter Symptoms in Infants

Cronobacter infection symptoms in infants usually begin with a fever, poor feeding, excessive crying, or very low energy. Some babies may also have seizures from this infection. The Centers for Disease Control and Prevention (CDC) says that “babies with these symptoms should be taken to a medical provider as soon as possible.”

Other symptoms may include irritability, temperature changes, jaundice, grunting breaths, or abnormal body movements.

This bacterium can cause bloodstream infections, leading to sepsis along with brain abscess, developmental delays, motor impairments, and death. In fact, recent reports estimate that around 20% of infants with meningitis or bloodstream infections due to Cronobacter infections in the United States have died from complications of the infection.

Cronobacter Infections in Older Children and Adults

Older children and adults can also become sick from Cronobacter exposure. The bacteria can infect people of all ages.

In addition to infection by consumption, Cronobacter can also get into the urinary tract and cause infection there.

These bacteria can also infect cuts, scrapes, or places where people have had surgeries.

Bloodstream Cronobacter infections are more common in adults over 65 years and those with a weakened immune system due to illness or existing conditions, such as those being treated with immune-suppressing drugs for cancer, organ transplants, or other illness. Those with HIV infections or certain genetic conditions are also more susceptible to Cronobacter infection.

Did You Purchase Products Involved in This Dairy Manufacturer Crecelac Infant Formula Contamination Recall?

Did you purchase products involved in this Dairy Manufacturer Inc. recall for infant formula contamination and need legal advice?

Consumers put trust in commercially sold products. There is an expectation that the foods we buy are safe and free from harmful substances. Consumers rightfully assume that a food manufacturer holds the appropriate permits and inspections necessary for their products. When companies skirt the rules and produce potentially dangerous and life-threatening products, lives are at risk.

Situations like this Dairy Manufacturer, Inc. Crecelac infant formula contamination recall put our most vulnerable population – infants, at risk.

The Lange Law Firm, PLLC is an experienced Food Poisoning Law Firm with a successful track record for helping families with cases just like yours. Call (833) 330-3663 or fill out the online submission form for a free consultation and to go over your options.

By: Heather Van Tassell (contributing writer, non-lawyer)