Agency classClass IOur severity:Severe FDA (Food)·F-0921-2022·Announced 2022-03-16

Abbott Similac Total Comfort Infant Formula Recalled for Pathogen Contamination

Abbott Similac Total Comfort infant formula is recalled due to potential contamination with Cronobacter sakazakii and Salmonella Newport, following consumer complaints in infants and evidence of the pathogen 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: FDA Class I classification for infant formula with evidence of pathogenic contamination (Cronobacter sakazakii, Salmonella Newport) and consumer complaints in infants, a vulnerable population at high risk from these pathogens.

Plain-English summary

Abbott Laboratories has recalled Similac Total Comfort infant formula (12.6 oz cans, batch code 35050K800) due to potential contamination with Cronobacter sakazakii and Salmonella Newport. The recall was initiated following consumer complaints related to these pathogens in infants and the discovery of Cronobacter sakazakii evidence in the manufacturing facility where the product was produced.

The affected product was distributed nationwide in the United States and internationally. Affected consumers should discontinue use of this formula batch and consult their healthcare provider if they have concerns about their infant's health.

This is a Class I recall, indicating a serious health hazard. Parents and caregivers should check the batch code (35050K800) on their formula cans and not use affected product.

The recalled product

Product: Abbott Similac Total Comfort 12.6oz. can. 6 cans per case. Item numbers: 6259962 Retail UPCs: 070074119953
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 13,737

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Batches: 35050K800

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