Elevated risk U.S. Food and Drug Administration

Enfamil Nutramigen Powder infant formula in 12.6 and 19.8oz cans recall: Potential Cronobacter sakazakii contamination

Recall published 2+ years ago

Potential Cronobacter sakazakii contamination

Enfamil Infant formula & baby food — recalled infant formula & baby foodEnfamil Infant formula & baby food — recalled infant formula & baby food (photo 2)Enfamil Infant formula & baby food — recalled infant formula & baby food (photo 3)Enfamil Infant formula & baby food — recalled infant formula & baby food (photo 4)
4 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Microbial contamination

The problem here is microbial contamination, so the recall covers the production codes listed rather than the brand as a whole.

What the notice says: Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine).

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
December 30, 2023
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Enfamil
Product type
Infant formula & baby food
Distribution
Nationwide
UPC codes
300871239418, 300871239456
Reports of harm
No illnesses or adverse consumer reactions have been reported to date.

Products covered by this recall

Nutramigen Powder infant formula in 12.6 and 19.8oz cans

What the company announced

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” (Photo: Business Wire).

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.:

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”.

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.

If parents have any questions, they should consult with their pediatrician or contact us at 866-534-9986 24/7 or by email at [email protected] .

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. Product 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 [email protected] 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 .

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 9 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 300871239418
  • 300871239456

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • ZL3FPE
  • ZL3FXJ
  • ZL3FQD
  • ZL3FMH
  • ZL3FHG

Package size

Match the net weight or the piece count on the front of the pack.

  • 19.8 oz
  • 12.6 oz

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

Enfamil — The problem here is microbial contamination, so the recall covers the production codes listed rather than the brand as a whole.

  1. Stop eating it and keep it separate from other food.
  2. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.
  3. Bag and bin it, or return it to the store for a refund.
  4. Clean and sanitise the fridge shelf, container or surface it was stored on.

Refunds, and what else you can claim

The purchase price is the floor, not the ceiling. Where a recall caused you a real cost, say so.

  • Claim the refund at the store first; it is the fastest route and needs the least paperwork.
  • If you bought several packs over time, list them. Firms routinely settle for more than a single unit when a customer asks.
  • Medical costs, lost earnings or a spoiled event are not handled at the service desk. Write to the company contact on this page instead, with dates and documents.
  • Keep copies of everything you send. If a recall caused harm, that file is what any later claim rests on.

Remedy named in the notice: Product with the batch codes listed above should be disposed of, or contact us for a total refund.

Company contact: Reckitt/Mead Johnson Nutrition — Consumers: 866-534-9986, [email protected] — Media: [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Enfamil infant formula & baby food recalled?

Potential Cronobacter sakazakii contamination Cronobacter bacteria can cause severe, life-threatening infections (sepsis) or meningitis (an inflammation of the membranes that protect the brain and spine).

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 300871239418, 300871239456; lot code ZL3FPE, ZL3FXJ, ZL3FQD. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

The notice says: Product with the batch codes listed above should be disposed of, or contact us for a total refund.

Where was the recalled product sold?

It was distributed nationwide.

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