Agency classClass IOur severity:Severe FDA (Food)·F-0925-2022·Announced 2022-03-16

Abbott Similac infant formula recalled for pathogen contamination

Abbott is recalling Similac infant formula due to possible contamination with Cronobacter sakazakii and Salmonella Newport. The recall covers approximately 103,025 cases distributed nationwide and worldwide.

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 carries a minimum severity level of 4 (Severe). The recall involves high-risk pathogens (Cronobacter sakazakii and Salmonella Newport) associated with consumer complaints in infants, indicating serious illness risk. The detection of Cronobacter sakazakii in the manufacturing facility underscores the severity of contamination.

Plain-English summary

Abbott Laboratories is recalling multiple Similac infant formula products, including Similac Advance Step-2 (22.5 oz. jars), Similac Advance (34 oz. cans), and Similac Pro-Advance (20.6 oz. and 859 g jars). The recall involves approximately 103,025 cases distributed in the United States and worldwide.

The recall was initiated due to consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants, and due to evidence of Cronobacter sakazakii found in the manufacturing facility where the product was produced.

Infants who have consumed the affected formula may be at risk. Consumers who have purchased any of the recalled products should stop using them immediately and contact Abbott Laboratories or their healthcare provider for guidance. Parents and caregivers should consult with their pediatrician about alternative feeding options.

The recalled product

Product: Abbott Similac Advance Step-2 22.5oz. plastic jar. 6 jars per case. Abbott Similac Advance 34oz. can. 6 cans per case. Abbott Similac Pro-Advance 20.6oz. and 859g. plastic jar. 6 jars per case. Item numbers: 6499113 6698313 6818113 6818313 Retail UPCs…
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 103,025

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