12-31-2023 2:33pm

Select Batches of Nutramigen Hypoallergenic Infant Formula Powder by Reckitt/Mead Johnson Nutrition: Recall - Due to Possible Health Risk

Anita Johnson-Brown Editor

Please note the following information:

Affected Categories: Consumers, Health Professionals, Pediatrics, and Gastroenterology.

ISSUE: Reckitt/Mead Johnson Nutrition (MJN) is recalling specific batches of Nutramigen Powder from the US market due to potential contamination with Cronobacter sakazakii. The contamination was identified in products sampled outside the US. It is important to note that all products in question underwent extensive testing by MJN and tested negative for the bacteria.

Nutramigen in 12.6 oz and 19.8 oz containers with a manufacturing date of June 2023 are part of the recall. These products were primarily distributed in June, July, and August 2023. As most of the affected products have been consumed, there is limited availability of the remaining stock of this infant formula. The affected products were distributed through retail stores across the US.

To identify the recalled products, please look for the batch code on the bottom of the can. The batch codes for the recalled products are provided in the table below:

By Anita Johnson-Brown| The Los Angeles News

12.6 oz cans

ZL3FHG

ZL3FMH

ZL3FPE

ZL3FQD

ZL3FXJ

19.8 oz cans

ZL3FRW

This part of the article was shared via FDA Medwatch and updated by Anita Johnson-Brown

According to FDA MedWatch, The products have a UPC Code of 300871239418 or 300871239456 and a “Use By Date” of “1 Jan 2025”. No other U.S.-distributed Nutramigen batches or other Reckitt products are impacted.

Reckitt/Mead Johnson Nutrition manufactured additional products during this finished product campaign and distributed them outside of the U.S. Reckitt/Mead Johnson Nutrition will be contacting the regulatory authorities in each of those countries to determine the proper disposition of those products.

There are no reports of illnesses or adverse events to date.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND:

Nutramigen Powder is a specialty infant formula for the dietary management of Cows Milk Allergy.
Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (inflammation of the membranes that protect the brain and spine). Symptoms of sepsis and meningitis may include poor feeding, irritability, temperature changes, jaundice (yellow skin and whites of the eyes), grunting breaths, and abnormal movements. Cronobacter infection may also cause bowel damage and may spread through the blood to other parts of the body.

RECOMMENDATIONS:

Consumers who purchased Nutramigen should check the bottom of the can to identify whether the batch number is affected. Products with the batch codes listed above should be disposed of. Contact the company for a total refund at 866-534-9986 or by email at consumer.relations@rb.com. The company will help verify if this product was impacted.
If you have any concerns, contact your healthcare provider.
If parents have any questions, they should consult with their pediatrician or the company at 866-534-9986 24/7 or by email at consumer.relations@rb.com.
Review the FDA's Constituent Update for additional information.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download the form or call 1-800-332-1088 to request a reporting form, then complete and return it to the address on the form, or submit it by fax to 1-800-FDA-0178.

This part of the article was shared via FDA Medwatch and updated by Anita Johnson-Brown