Agency classClass IOur severity:Critical FDA (Food)·F-0928-2022·Announced 2022-03-16

Abbott Similac infant formula recalled for possible bacterial contamination

Abbott is recalling Similac infant formula products for possible contamination with Cronobacter sakazakii and Salmonella Newport following consumer complaints of illness 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: This recall is classified as FDA Class I, which indicates a serious hazard to health. Cronobacter sakazakii and Salmonella Newport are significant pathogens capable of causing serious illness in infants. Consumer complaints involving these pathogens and evidence of contamination in the manufacturing facility establish the Critical designation.

Plain-English summary

Abbott Laboratories is recalling approximately 109,848 cases of Similac infant formula products, including Similac Total Comfort (638g plastic jars and 8oz cans) and Similac Advance Step-2 (34oz cans). The affected batches include: 23420SH00, 32608SH00, 26820K800, 33725K800, 37277K800, 26821SH00, 28089SH00, 29245SH00, 32607SH00, 34861SH00, and 36124SH00.

The recall has been issued following consumer complaints related to Cronobacter sakazakii and Salmonella Newport contamination in infants who consumed the product. Additionally, Cronobacter sakazakii was identified in the manufacturing facility where the product was produced.

The affected products have been distributed nationwide and worldwide. Parents and caregivers who have purchased these products should stop using them immediately and consult their healthcare provider if their infant has consumed the product and is experiencing symptoms of illness.

The recalled product

Product: Abbott Similac Total Comfort 638g. plastic jar and 8oz. can. 6 units per case. Abbott Similac Advance Step-2 34oz. can. 6 cans per case. Item numbers: 6635013 6635113 6698413 Retail UPCs: 055325626602 055325626626 055325001652
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 109,848

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