Agency classClass IOur severity:Severe FDA (Food)·F-0943-2022·Announced 2022-03-16

Abbott Similac 360 Infant Formula recalled for Cronobacter and Salmonella

Abbott is recalling Similac 360 Total Care Infant Formula due to consumer complaints of Cronobacter sakazakii and Salmonella Newport in infants, with Cronobacter found in the manufacturing facility.

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: This is an FDA Class I recall, which per the rubric requires a minimum score of 4. The recall involves high-risk pathogens (Cronobacter sakazakii and Salmonella Newport) with documented consumer complaints of illness in infants and evidence of contamination in the manufacturing facility.

Plain-English summary

Abbott Laboratories is recalling Abbott Similac 360 Total Care Infant Formula with Iron due to potential contamination with Cronobacter sakazakii and Salmonella Newport. The recall was initiated following consumer complaints related to these pathogens in infants, and Cronobacter sakazakii was identified in the manufacturing facility where the product was produced.

The affected products include 20.6 oz and 30.3 oz plastic jars and 7 oz cans, with a total of 342,054 cases affected. The products were distributed nationwide in the United States and worldwide.

Cronobacter sakazakii and Salmonella Newport are serious pathogens that pose significant health risks, particularly to infants. This is classified as a Class I recall by the FDA, indicating a serious health hazard.

The recalled product

Product: Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30.3oz. palstic jar. 4 jars per case. 7oz. can. 6 cans per case. Item numbers: 68063 68065 68109 Retail UPCs: 070074680644 070074680668 070074681108
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 342,054

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