The Recall Desk
Agency classClass IOur severity:CriticalFDA (Food)·F-0937-2022·Announced 2022-03-16

Abbott Similac Sensitive Infant Formula Recalled for Cronobacter and Salmonella Contamination

Abbott is recalling Similac Sensitive Infant Formula with Iron due to potential Cronobacter sakazakii and Salmonella Newport contamination linked to consumer complaints about infant illness. The FDA classified this as a Class I recall.

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 is an FDA Class I recall involving high-risk pathogens (Cronobacter sakazakii and Salmonella Newport) with consumer complaints of illness in infants, a vulnerable population at particular risk of serious harm from these organisms.

Plain-English summary

Abbott Laboratories is recalling Similac Sensitive Infant Formula with Iron 22.5 oz. plastic jars due to potential contamination with Cronobacter sakazakii and Salmonella Newport. The affected product was distributed nationwide and worldwide.

The contamination was identified following consumer complaints related to these organisms in infants. Evidence of Cronobacter sakazakii was also found in the manufacturing facility where the product was produced. Both pathogens can cause serious illness in infants.

Consumers with affected products should stop using them immediately. Affected batch codes are: 23426SH00, 23427SH00, 25577SH00, 25579SH00, 25665SH00, 25681SH00, and 26840SH00. Contact Abbott Laboratories or the FDA if you have questions about whether your product is affected.

The FDA classified this as a Class I recall, indicating a situation where use of the product could cause serious adverse health consequences.

The recalled product

Product
Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar. 6 jars per case. Item numbers: 5081776 Retail UPCs: 070074508184
Manufacturer
Abbott Laboratories
Category
Food — Infant Formula
Hazard
Affected units
46,757

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 →

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