Reckitt/Mead Johnson Nutrition’s infant formula Recall (30.12.2023)

675,030 cans sold in the U.S. recalled after contamination found, FDA says

Recall Alert: Reckitt/Mead Johnson Nutrition's infant formula

Summary
Announcement
What to do?

Summary

Company Announcement Date:

December 30, 2023

FDA Publish Date:

December 31, 2023

Product Type:

Food & Beverages, Infant Formula & Foods, Foodborne Illness

Reason for Announcement:

Potential Cronobacter sakazakii contamination

Company Name:

Reckitt/Mead Johnson Nutrition

Brand Name:

Enfamil

Product Description:

Nutramigen Powder infant formula in 12.6 and 19.8oz cans

Company Announcement

All product tested by MJN was confirmed negative for contaminants.
No illnesses or adverse consumer reactions have been reported to date.
No Nutramigen liquid formulas or any other Reckitt nutrition products are impacted.

Recalled product batches are ZL3FRW, ZL3FPE, ZL3FXJ, ZL3FQD, ZL3FMH, ZL3FHG with a UPC code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025”.

PARSIPPANY, N.J.–(BUSINESS WIRE)–Reckitt/Mead Johnson Nutrition (MJN), a producer of nutrition products, announced today that it has voluntarily chosen to recall from the U.S. market select batches of Nutramigen Powder, a specialty infant formula for the dietary management of Cows Milk Allergy (CMA) in 12.6 and 19.8 oz cans, 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.

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.

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. There are no reports of illnesses or adverse events to date. 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 following recalled product batch codes and can size associated with each batch were distributed in the U.S. can be identified by batch codes listed on the FDA’s website, which include:

ZL3FHG (12.6 oz cans);
ZL3FMH (12.6 oz cans);
ZL3FPE (12.6 oz cans);
ZL3FQD (12.6 oz cans);
ZL3FRW (19.8 oz cans);
ZL3FXJ (12.6 oz cans).

The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025”.

No other U.S. distributed Nutramigen batches or other Reckitt products are impacted.

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

If parents have any questions, they should consult with their pediatrician or contact us at 866-534-9986 24/7 or by email at consumer.relations@rb.com.

We are committed to the highest level of quality and safety, and it is for this reason that we have taken this measure. Other testing of the batches in question tested negative for Cronobacter and other bacteria.

The health and safety of infants is our highest priority. All of our products undergo rigorous and industry-leading quality tests and checks to ensure that they meet or exceed all standards set by regulatory bodies, including the World Health Organization and the U.S. Food and Drug Administration. It is for this reason that we have confidence in the safety and quality of every infant formula we make.

What Consumers Should Do if They Purchased This Product

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, or contact us for a total refund. Please contact us at 866-534-9986 or by email at consumer.relations@rb.com, and we will help verify if this product was impacted. If you have any concerns, contact your health care provider. For more information, please visit us at www.enfamil.com

Update

January 10, 2024

Products produced during the same finished product campaign as the U.S.-recalled product were distributed in at least the following countries: Argentina, Belgium External Link Disclaimer, Belize, Canada External Link Disclaimer, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Ireland External Link Disclaimer, Israel, Jamaica, Mexico, Nicaragua, Peru, Poland External Link Disclaimer, Spain External Link Disclaimer, United Kingdom External Link Disclaimer, and Venezuela. Reckitt/Mead Johnson Nutrition has indicated to FDA that the company has already contacted the regulatory authorities in each of the countries to determine the proper disposition of these products.

December 31, 2023

On December 28, 2023, the FDA received information concerning a confirmatory analysis for a Cronobackter sakazakii positive finding in Nutramigen, a hypoallergenic powdered infant formula product manufactured by Reckitt/Mead Johnson Nutrition. The Israeli Ministry of Health identified the positive finding during routine sampling during import operations. The FDA has initiated an inspection at the Reckitt/Mead Johnson Nutrition Zeeland, MI facility and Reckitt/Mead Johnson Nutrition is voluntarily recalling certain Nutramigen Hypoallergenic Infant Formula Powder products due to possible Cronobacter sakazakii contamination.

The voluntarily recalled Nutramigen product was manufactured between June 6, 2023, and June 29, 2023, and includes batch numbers: ZL3FHG (12.6 oz cans), ZL3FMH (12.6 oz cans), ZL3FPE (12.6 oz cans), ZL3FQD (12.6 oz cans), ZL3FRW (19.8 oz cans), and ZL3FXJ (12.6 oz cans). The products have a UPC Code of 300871239418 or 300871239456 and “Use By Date” of “1 Jan 2025. 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 known illnesses associated with this product to date, and likely most of the product that was distributed in the U.S. has already been consumed. Consumers who have Nutramigen Powdered Infant Formula with the above batch numbers should stop using it and throw it away.

Additional information on the recall is available:

Reckitt’s Mead Johnson was one of three baby formula manufacturers to face warning letters from the FDA in August. Among the issues scrutinized by the agency were detections of Cronobacter in “high and critical hygiene zones” of the Zeeland plant.

Disclaimer: The content available on Little Baby Formula’s website is intended solely for your general knowledge. Little Baby Formula does not offer medical guidance or participate in medical practices. We recommend consulting your pediatrician before choosing to use bottle-feeding. Results may differ from person to person.

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