Nutramigen, a specialty hypoallergenic baby formula meant for infants with severe milk allergies and gastrointestinal issues, has been voluntarily recalled across the United States and Canada after testing revealed possible contamination with Cronobacter sakazakii bacteria. The recall, issued by Reckitt, covers around 657,000 cans of powdered formula, some of which later tested positive for the deadly bacteria.
The potentially contaminated product was manufactured at Reckitt’s facility in Sturgis, Michigan between August 2022 and November 2022. So far, the batches under recall were distributed throughout the U.S. as well as to Canada. This marks one of the first major infant formula recalls of 2024, setting off alarm bells for parents still reeling from the nationwide shortage in 2023.
Over 675,000 Cans Recalled Over Bacteria Risks
The U.S. Food and Drug Administration (FDA) made the announcement regarding the voluntary recall on December 30, 2023, though Reckitt had already begun notifying retailers in late December of its decision. In total, around 675,540 cans of Nutramigen are being pulled from store shelves.
The recall covers 13 batches of Nutramigen powdered formula, including 12.6 oz and 12.4 oz sized cans. The products have expiration dates ranging from January 2024 to November 2024. The affected batches have zinc codes between 292 and 306, which can be found at the bottom of each can underneath the Best By date.
|Zinc Code Range
|Use By Date Range
|Nutramigen Powdered Baby Formula
|292 through 306
|January 2024 through November 2024
So far, no illnesses have been reported in connection with these products. However, parents are advised to immediately stop using the formula and consult their pediatrician about alternative feeding options.
Possible Contamination With Cronobacter Bacteria
Routine testing discovered that some of the recalled formula had tested positive for Cronobacter sakazakii, a germ that can be extremely dangerous if ingested by infants.
Cronobacter bacteria can cause severe blood infections or meningitis, an inflammation of the membranes that protect the brain and spine. Symptoms include poor feeding, irritability, temperature changes, jaundice, grunting breaths, and abnormal movements. The infection is fatal in 10-80 percent of cases, with newborns and infants under two months old at the greatest risk.
While rare, Cronobacter sakazakii is a well-known contaminant in powdered infant formulas, as the bacteria can survive in very dry conditions. Reckitt stated that no distributed product has tested positive for the bacteria, though retailers and consumers should take precautions by not using or selling any of the recalled formula.
Reckitt Expands Recall Over More Contamination Concerns
Initially, the recall only covered batches of Nutramigen LOT Formula. However, earlier this month Reckitt decided to expand the recall to include two other powdered hypoallergenic formulas – Alimentum and EleCare.
This came after an FDA inspection of Reckitt’s Sturgis manufacturing plant found evidence of Cronobacter sakazakii in the facility. Though no distributed cans have tested positive, the company decided to take extra precaution by pulling any specialty formula made at the plant over the last few months.
Altogether, around 1.76 million cans are now under recall, making this one of the largest infant formula actions in recent years. Like the original recall, no illnesses have been reported related to these products.
Senator Sends Letter With Questions Surrounding Recall
The scale of the recall has raised eyebrows in Washington, with lawmakers still anxious after the nationwide formula shortage last year. Senator Margaret Wood Hassan (D-NH) sent an open letter to the FDA on January 8, saying she was “deeply concerned” about the potential impact these recalls could have.
Hassan asked the FDA to provide more details on what exactly triggered the recalls, whether other safety issues had been discovered at Reckitt’s Sturgis plant, and how much formula inventory was currently available in the U.S.
“I am committed to ensuring that families have access to safe baby formula, and I look forward to your prompt response on what actions the FDA is taking to ensure baby formula supply and safety,” Hassan wrote.
So far, the FDA has downplayed worries over inventory, stating that specialty formulas only make up a small percentage of the total market. However, patient advocacy groups have warned the recall could severely limit options for families with babies suffering from gastrointestinal disorders.
What Should Parents Do?
With over 1.76 million cans pulled from store shelves, the Nutramigen recall has sparked confusion and concern among parents. The FDA has advised consumers not to use any of the recalled powdered infant formula, even if it does not look or smell spoiled.
Parents should carefully check any Nutramigen formula in their home to see if it matches any of the product codes listed in the recall. All recalled formula should be safely thrown out. Families should then contact their health care provider to find an alternative formula that meets their child’s dietary needs.
While worrying, so far Cronobacter infections have not been reported in connection with these products. However, symptoms typically take 2-7 days to appear, meaning illnesses could still emerge. Caregivers should closely monitor infants who have consumed any of the recalled formula batches and be alert for any signs of poor feeding or fever.
Reckitt has set up a 24-hour consumer hotline at 1-800-479-0551 to answer any questions about the recall.
What Led To The Recall?
The voluntary recall follows routine internal testing at Reckitt’s Sturgis manufacturing facility. On September 16, 2022, the company discovered positive Cronobacter sakazakii results from environmental samples taken in the facility. However, after this finding, no distributed product ever tested positive for the bacteria.
Reckitt claims that all batches of infant formula undergo rigorous testing before leaving the facility, including checks for Cronobacter. However, the company decided to issue a recall out of an abundance of caution after these environmental samples came back positive.
The recall also came shortly after a September FDA inspection of the Sturgis plant, though the agency has not clarified if this played any role. Previously, the same Reckitt plant was at the heart of the nationwide formula shortage after an FDA shutdown due to unsanitary conditions.
While no direct cause has been identified, lawmakers and parents alike are seeking more transparency around what led to these latest recalls. Reckitt insists that no distributed cans have tested positive for bacteria and that the recall was voluntary and preventative. Even so, the case highlights lingering vulnerabilities around infant formula safety.
What Happens Next?
In response to Senator Hassan’s letter, the FDA says it is working closely with Reckitt to monitor market supply and prevent future shortages. The agency also plans to share more details surrounding the recall “very soon” per an FDA spokesperson.
Patient advocacy groups are urging families to check any formula they have at home against the recall list. They also advise speaking with a healthcare provider before switching formulas, as an improper switch could aggravate symptoms.
As no distributed cans have tested positive for bacteria, the FDA currently believes there is no increased risk to infants who have already consumed the formula. However, parents should still monitor their babies closely over the next week for any symptoms of Cronobacter infection.
While an unsettling development, officials seem confident the recall will not cause the same level of market disruption as 2022. Still, regulators plan to scrutinize conditions and safety protocols at Reckitt’s Sturgis manufacturing plant in light of these recalls. Increased oversight and accountability will be key to restoring public trust in infant formula production after two years of high profile safety issues.
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