One of the dominant infant formula manufacturers in the U.S. is recalling two batches of its popular Enfamil product over potential health risks.
Reckitt announced on Monday that it is voluntarily recalling some 145,000 cans of ProSobee Simply Plant-Based Infant Formula "due to a possibility of cross-contamination with Cronobacter sakazakii," a bacteria that can cause rare but life-threatening infections in newborns.
The company says no illnesses have been reported and all of the batches have tested negative for the bacteria, calling it "an isolated situation." Still, it is urging anyone who purchased the affected product to either dispose of it or return it to the place of purchase for a total refund.
"After a thorough investigation, we have identified the root cause, which was linked to a material from a third party," Reckitt said. "We have taken all appropriate corrective actions, including no longer sourcing this material from the supplier."
The recall specifically concerns 12.9 oz containers of the plant-based formula that were manufactured between August and September 2022 and sold in retail stores throughout the U.S., Puerto Rico and Guam.
Customers can check the bottom of their cans to see if they are part of the two recalled batches (ZL2HZF and ZL2HZZ), which have number 300871214415 beneath the barcode and a use-by date of March 1, 2024.
Reckitt says parents with concerns should contact their pediatrician or the company for more information.
If the name Cronobacter sounds familiar, it's because that was the bacteria behind the Abbott Nutrition formula recalls that contributed to the nationwide baby formula shortage last year.
After reviewing the causes of the shortage, the U.S. Food and Drug Administration concluded in September that a major area of need is a better scientific understanding of Cronobacter and corresponding control measures and oversight.
It has since released a prevention strategy to enhance the safety of powdered infant formula.
Cronobacter germs are found naturally in the environment and can live in dry foods like powdered milk or infant formula.
The Centers for Disease Control and Prevention says that getting sick from the bacteria is rare — two to four cases are reported each year, though that's likely an undercount — but infections can be life-threatening for infants.
Cronobacter germs can cause sepsis (a dangerous blood infection) or meningitis (swelling of the linings that protect the brain and spinal cord), and could also cause bowel damage or spread through the blood to other parts of the body.
Infants born prematurely, younger than two months old and with weakened immune systems are more likely to get sick.
The CDC says cronobacter illness in infants usually starts with fever and poor feeding, excessive crying, very low energy and possible seizures, and that parents noticing these symptoms should seek out medical help right away.
And there are steps caregivers can take to try to prevent cronobacter contamination in the first place, it says.
If you're using formula, make sure to clean, sanitize and store feeding items safely, including taking apart items like bottles and breast pump parts to clean them thoroughly after use. Don't put the formula scoop on kitchen surfaces, keep lids and scoops clean and dry and close formula containers as soon as possible.
It's also important to keep your kitchen counters, sinks and hands clean. The CDC recommends washing your hands with soap and water — or a hand sanitizer with at least 60% alcohol — before touching your baby's mouth or anything that goes into it, like pacifiers.
Powdered infant formula is not sterile, the CDC warns, so you may want to consider using liquid formula if possible, especially for babies at higher risk. If your baby is at higher risk, you could also prepare powdered formula with hot water according to the directions here.
As far as usage and storage, the CDC says to use prepared infant formula within one hour from the start of feeding and two hours of preparation, and to throw away (rather than refrigerate) any leftovers. If you don't plan to start feeding your baby with the prepared formula immediately, put it in the fridge and use it within 24 hours.
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