Elevated risk U.S. Food and Drug Administration

Similac, Alimentum, and EleCare Powder Infant Formula recall: Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport

Recall published 4+ years ago

Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport.

Similac, Alimentum, and EleCare Infant formula & baby food — recalled infant formula & baby food
Photo published by U.S. Food and Drug Administration with the recall notice.

The hazard: Salmonella contamination

Salmonella is what triggered this notice. The bacteria transfer readily from hands and surfaces, which is why the clean-up matters as much as the disposal.

What the notice says: It can cause fever, poor feeding, excessive crying or low energy as well as other serious symptoms.

Why it matters: Salmonella is one of the most common causes of foodborne illness in the United States. It spreads easily from a contaminated product to hands, taps, cloths and other food in the same kitchen.

Symptoms and when to call a doctor

The CDC describes salmonellosis as diarrhoea, fever and stomach cramps that usually begin between six hours and six days after exposure and last about four to seven days. Most people recover without treatment. Children under five, adults over 65 and people with weakened immune systems are more likely to become seriously ill. Seek care for diarrhoea with a high fever, bloody stools, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration such as very little urine, a dry mouth or dizziness when standing.

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
February 17, 2022
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Similac, Alimentum, and EleCare
Product type
Infant formula & baby food

Products covered by this recall

Powder Infant Formula

What the company announced

The company has issued a correction to the previous announcement..

Certain specialty and metabolic formulas have been tested and released by Abbott Nutrition on a case-by-case basis. Parents and caregivers of infants receiving this specialty and metabolic formula should not reference the recall product description below, but instead should enter the product lot code found at the bottom of their package by using the “Check Lot Number” feature at the bottom of the company’s webpage ( similacrecall.com ) or by calling Abbott Nutrition at 1-800-881-0876.

Abbott (NYSE: ABT) is initiating a proactive, voluntary recall of powder formulas, including Similac, Alimentum and EleCare manufactured in Sturgis, Mich., one of the company's manufacturing facilities. The recall does not include any metabolic deficiency nutrition formulas.

Abbott is voluntarily recalling these products after four consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants who had consumed powder infant formula manufactured in this facility.

Additionally, as part of Abbott's quality processes, we conduct routine testing for Cronobacter sakazakii and other pathogens in our manufacturing facilities. During testing in our Sturgis, Mich., facility, we found evidence of Cronobacter sakazakii in the plant in non-product contact areas. We found no evidence of Salmonella Newport. This investigation is ongoing.

Importantly, no distributed product has tested positive for the presence of either of these bacteria, and we continue to test. Abbott conducts extensive quality checks on each completed batch of infant formula, including microbiological analysis prior to release. All finished products are tested for Cronobacter sakazakii, Salmonella Newport and other pathogens and they must test negative before any product is released. Additionally, retained samples related to the three complaints for Cronobacter sakazakii tested negative for Cronobacter sakazakii. And the retained sample related to the complaint for Salmonella Newport tested negative for Salmonella Newport .

While Abbott's testing of finished product detected no pathogens, we are taking action by recalling the powder formula manufactured in this facility with an expiration of April 1, 2022, or later. No Abbott liquid formulas, powder formulas, or nutrition products from other facilities are impacted by the recall.

Cronobacter sakazakii is commonly found in the environment and a variety of areas in the home. It can cause fever, poor feeding, excessive crying or low energy as well as other serious symptoms. It's important to follow the instructions for proper preparation, handling and storage of powder formulas.

"We know parents depend on us to provide them with the highest quality nutrition formulas," said Joe Manning, executive vice president, nutritional products, Abbott. "We're taking this action so parents know they can trust us to meet our high standards, as well as theirs. We deeply regret the concern and inconvenience this situation will cause parents, caregivers and health care professionals."

What Parents and Caregivers Should Do

The products under recall have a multidigit number on the bottom of the container starting with the first two digits 22 through 37, contains K8, SH, or Z2 and with an expiration date of April 1, 2022, or after.

To find out if the product you have is included in this recall, visit similacrecall.com and type in the code on the bottom of the package, or call +1-800-986-8540 (U.S.) and follow the instructions provided. No action is needed for previously consumed product. If you have questions about feeding your child, contact your healthcare professional.

Some product was distributed to countries outside the U.S. A list of these products can be found at similacrecall.com .

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com , on LinkedIn at www.linkedin.com/company/abbott-/ , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews .

SOURCE Abbott

For frequently asked questions, please click here.

For further information: Abbott Media: Vicky Assardo, (224) 668-1505; Jonathon Hamilton, (224) 667-8646; Ellen Wichman, (224) 667-8522; Spanish-speaking media in U.S.: John Koval, (224) 668-5355; Spanish-speaking media outside the U.S.: Jorge Solorzano, +52 55-3333-7604; Abbott Financial: Laura Dauer, (224) 667-2299

FDA Press Announcement

FDA Advisory

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 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • April 1, 2022

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 Salmonella

Similac, Alimentum, and EleCare — Salmonella is what triggered this notice. The bacteria transfer readily from hands and surfaces, which is why the clean-up matters as much as the disposal.

  1. Stop eating the product and keep it away from anything ready to eat.
  2. If you repackaged or froze it, check the freezer too. Salmonella is not killed by freezing.
  3. Watch everyone who ate it for about a week, and call a doctor sooner for a child under five or an adult over 65.
  4. Bag it and bin it, or take it back to the store — do not feed it to pets or livestock either.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Abbott — Consumers: Abbott, +1-800-986-8540 — Media: Vicky Assardo, (224) 668-1505

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 Similac, Alimentum, and EleCare infant formula & baby food recalled?

Consumer complaints regarding Cronobacter sakazakii, Salmonella Newport. It can cause fever, poor feeding, excessive crying or low energy as well as other serious symptoms.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: best-by date April 1, 2022. 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 the product and keep it away from anything ready to eat.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

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