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Technolac Recall: FDA Announces Voluntary Nationwide Recall of Powdered Infant Formula
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On december 22, 2023, the U.S. Food and Drug Administration (FDA) announced that Reckitt is voluntarily recalling select lots of powdered infant formula manufactured at its facility in Wisconsin. This recall impacts products sold under the brand names Enfamil, ProSobee, and Nursette. The recall was initiated after the discovery of Cronobacter sakazakii and Salmonella Newport bacteria in product samples and at the manufacturing facility. These bacteria can be notably perilous for infants, perhaps leading to severe, life-threatening infections.
What Products are Affected?
the recall affects specific lots of powdered infant formula with “use by” dates ranging from June 2024 through September 2024. The affected products include:
- Enfamil: Various sizes of powdered infant formula
- ProSobee: Various sizes of powdered infant formula
- Nursette: Various sizes of powdered infant formula
A complete list of recalled lot numbers can be found on the FDA website: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/reckitt-voluntarily-recalls-certain-enfamil-prosobee-and-nursette-powdered-infant-formula-products. Consumers should check the “use by” date and lot number printed on the bottom of the container to determine if their product is affected.
Why Was the Recall Issued?
The FDA’s examination revealed the presence of Cronobacter sakazakii and Salmonella Newport. cronobacter sakazakii is a rare but serious germ that can cause sepsis (blood infection) and meningitis in newborns. Salmonella Newport can cause diarrhea, fever, and abdominal cramps.Infants are particularly vulnerable to these infections, and symptoms can be severe.
The FDA initiated a whole genome sequencing investigation after receiving reports of infant illnesses. The investigation linked the illnesses to the consumption of powdered infant formula manufactured at the reckitt facility.
What Should Consumers Do?
The FDA advises consumers to take the following steps:
- Stop using the recalled product immediately.
- Do not purchase the recalled product.
- Contact your healthcare provider if your infant has experienced symptoms such as fever, vomiting, or changes in feeding behavior after consuming the recalled formula.
- Return the product to the place of purchase for a refund.
Reckitt is offering full refunds for all recalled products. Consumers can also contact Reckitt directly for assistance: https://www.enfamil.com/recall.
FDA’s Ongoing Investigation
The FDA is continuing its investigation into the manufacturing facility and the source of the contamination. The agency is working with Reckitt to ensure corrective actions are taken to prevent future contamination. This includes reviewing manufacturing processes, sanitation procedures, and quality control measures. https://www.fda.gov/news-events/press-announcements/fda-investigates-infant-formula-illnesses-and-announces-voluntary-recall
Key Takeaways
- Select lots of Enfamil, ProSobee, and Nursette powdered infant formula are being voluntarily recalled.
- The recall is due to the potential presence of Cronobacter sakazakii and Salmonella Newport.
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