Agency classClass IOur severity:Critical FDA (Food)·F-0924-2022·Announced 2022-03-16

Abbott Similac Advance infant formula recalled for pathogen contamination

Abbott recalls Similac Advance Step-1 infant formula due to Cronobacter sakazakii and Salmonella Newport detected in the product and manufacturing facility, following consumer complaints in 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 recalls involve serious health hazards with potential for serious adverse health consequences or death. This formula contamination with Salmonella Newport and Cronobacter sakazakii, combined with consumer complaints suggesting illnesses in infants and evidence of pathogen in the manufacturing facility, meets the critical threshold.

Plain-English summary

Abbott Similac Advance Step-1 infant formula is being recalled by Abbott Laboratories. The recall affects 54,507 cases in 22-ounce plastic jars and 34-ounce cans, distributed in the United States and worldwide.

The recall was initiated following consumer complaints related to Cronobacter sakazakii and Salmonella Newport in infants. Additionally, Cronobacter sakazakii was detected in the manufacturing facility where the product was produced.

Consumers who have purchased affected batches should discontinue use immediately. Affected products can be identified by item numbers 6499213 or 6698213, retail UPCs 055325000808 or 055325001638, and batch codes 28091SH00, 35007SH00, 24493SH00, 26773SH00, 27992SH00, 28174SH00, 31495SH00, 34815SH00, 36099SH00, or 37294SH00. Consumers with concerns about infant health should contact a healthcare provider.

The recalled product

Product: Abbott Similac Advance Step-1 22oz. plastic jar and 34 oz. can. 6 units per case. Item numbers: 6499213 6698213 Retail UPCs: 055325000808 055325001638
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 54,507

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