The Recall Desk
CriticalFDA (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.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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 0700
Manufacturer
Abbott Laboratories
Category
Food — Infant Formula
Hazard
  • cronobacter-sakazakii
  • salmonella-newport

Distribution

Distributed nationwide across the United States.

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