Agency classClass IOur severity:Critical FDA (Food)·F-0945-2022·Announced 2022-03-16

Abbott Similac Organic Infant Formula Recalled for Bacterial Contamination

Abbott Similac Organic infant formula products are recalled by the FDA due to potential Cronobacter sakazakii or Salmonella Newport contamination. Consumer complaints of illness in infants and manufacturing facility contamination triggered this 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 classified as FDA Class I, which according to the rubric criteria automatically warrants a minimum severity score of 4 for FDA recalls. The recall involves serious high-risk pathogens (Cronobacter sakazakii and Salmonella Newport) affecting a vulnerable population (infants) with documented consumer complaints indicating illness. This combination meets the Critical threshold.

Plain-English summary

Abbott Similac Organic infant formula products are being recalled by the FDA. The affected products include 7oz cans, 20.6oz plastic jars, and 23.2oz plastic jars. The recall encompasses 52,663 cases distributed nationwide and worldwide. Specific affected batches are: 24397K800, 27994SH00, 27995SH00, and 24400SH00.

The FDA initiated this Class I recall following consumer complaints indicating potential contamination with Cronobacter sakazakii or Salmonella Newport in infants who consumed the product. Additionally, testing of the manufacturing facility revealed evidence of Cronobacter sakazakii where the product was produced. Both pathogens pose significant health risks to infants.

Consumers who have purchased affected batches should discontinue use immediately. Parents and caregivers of infants who may have consumed the affected product should contact their healthcare provider for guidance. The product should be discarded or returned to the point of purchase.

The recalled product

Product: Abbott Similac Organic 7oz. can. 6 cans per case. Abbott Similac Organic with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 jars per case. 23.2oz plastic jar. 6 jars per case. Item numbers: 68013 68092 5082178 Retail UPCs: 070074680156 070074680934…
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 52,663

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: 24397K800 27994SH00 27995SH00 24400SH00

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

See all →

High
Chemistry analyzer control modules recalled over software that may give erroneous results
FDA (Devices) · 2025-12-24
High
Hematology analyzers recalled because saturation flags may not be applied
FDA (Devices) · 2025-11-19
High
CELL-DYN Ruby hematology analyzer system expiration date validation
FDA (Devices) · 2025-04-30
High
CELL-DYN Ruby Hematology Analyzer Expiration Date Software Defect
FDA (Devices) · 2025-04-30
High
CELL-DYN Ruby hematology analyzer expiration date software defect
FDA (Devices) · 2025-04-30

Same hazard · cronobacter sakazakii