Agency classClass IOur severity:Severe FDA (Food)·F-0927-2022·Announced 2022-03-16

Abbott Similac Alimentum Infant Formula Recalled for Bacterial Contamination

Abbott Laboratories recalls Similac Alimentum Infant Formula with Iron due to potential Cronobacter sakazakii and Salmonella Newport contamination. Consumer complaints related to infections in infants and manufacturing facility contamination prompted the FDA Class I recall.

The agency’s classification

FDA (Food): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification requires a minimum severity of 4. The recall involves high-risk bacterial pathogens (Cronobacter sakazakii and Salmonella Newport) in infant formula, the most vulnerable population, with documented consumer complaints of infections and manufacturing facility contamination.

Plain-English summary

Abbott Laboratories is recalling Similac Alimentum Infant Formula with Iron in 12oz, 19.8oz, and 7oz cans due to contamination with Cronobacter sakazakii and/or Salmonella Newport. The recall affects approximately 1.5 million cases distributed nationwide and internationally. This is an FDA Class I recall.

The FDA initiated this recall following consumer complaints related to Cronobacter sakazakii or Salmonella Newport infections in infants. Additionally, Cronobacter sakazakii was detected in the manufacturing facility where the product was produced. Both pathogens pose serious health risks, particularly to the vulnerable infant population.

Consumers who have purchased affected products should stop using them immediately and consult their pediatrician if an infant has consumed the recalled formula. Consumers may return the product to the point of purchase. Affected lot codes are listed on the FDA website and product packaging.

The recalled product

Product: Abbott Similac Alimentum Infant Formula with Iron 12oz. can. 6 jars per case; 19.8oz. can. 4 cans per case; 7oz. can. 6 cans per case Item numbers: 64715 64717 64719 Retail UPCs: 070074647128 070074647166 070074647180
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 1,511,774

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 41 recalled by Abbott Laboratories under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 41 products in this recall →

Same manufacturer · Abbott Laboratories

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Same hazard · cronobacter sakazakii