FDA MedWatch - Select Batches of Nutramigen Hypoallergenic Infant Formula Powder by Reckitt/Mead Johnson Nutrition

If your email program has trouble displaying this email, view as a webpage.

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

AUDIENCE: Consumer, Health Professional, Pediatrics, Gastroenterology

ISSUE: Reckitt/Mead Johnson Nutrition (MJN) is recalling from the U.S. market select batches of Nutramigen Powder due to a possibility of contamination with Cronobacter sakazakii in product sampled outside the U.S. All product in question went through extensive testing by MJN and tested negative for the bacteria.

Nutramigen in 12.6 and 19.8 oz containers was manufactured in June 2023 and distributed primarily in June, July, and August 2023. Based on the limited availability of the remaining stock of this special infant formula, it is believed that much, if not all, of the products recalled in the United States have been consumed. The products were distributed through retail stores nationwide. The batches in question can be identified by the batch code on the bottom of the can.

The batch codes for the recalled products are provided in table below: 

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 (an 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. Product 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 health care 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 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 form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

Follow us on Twitter at @FDAMedWatch