Agency classClass IOur severity:Critical FDA (Food)·F-0934-2022·Announced 2022-03-16

Abbott Similac Pro-Total Comfort Infant Formula recalled for Cronobacter and Salmonella

Abbott Similac Pro-Total Comfort Infant Formula is being recalled due to potential contamination with Cronobacter sakazakii and Salmonella Newport. Consumer complaints have been linked to these dangerous pathogens in affected infants.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification combined with documented consumer complaints indicating actual illnesses from high-risk pathogens (Cronobacter sakazakii and Salmonella Newport) in infants. Both criteria establish this as Critical severity.

Plain-English summary

Abbott Laboratories is recalling multiple sizes of Similac Pro-Total Comfort Infant Formula with Iron following detection of potentially harmful bacteria. The affected product is available in 20.1oz. and 22.5oz. plastic jars (4 per case), 34oz. plastic jars (6 per case), and 7oz. cans (6 per case). Approximately 766,561 cases have been distributed across the United States and internationally.

The recall stems from consumer complaints related to Cronobacter sakazakii and Salmonella Newport found in affected infants. Additionally, Cronobacter sakazakii was detected in the manufacturing facility where this formula was produced. These organisms are capable of causing serious illness, particularly in infants and young children.

The FDA has classified this recall as Class I, indicating the most serious level of health hazard. The affected product includes specific batch codes identified in the official FDA recall notice. Consumers who have this formula should consult with their healthcare provider or Abbott Laboratories regarding their individual situation.

The recalled product

Product: Abbott Similac Pro-Total Comfort Infant Formula with Iron 20.1oz. and 22.5oz. plastic jar. 4 jars per case. 34oz. plastic jar. 6 jars per case. 7oz. can. 6 cans per case. Item numbers: 66798 66939 67925 68107 Retail UPCs: 070074667997 070074669403 070074679266…
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 766,561

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