Agency classClass IOur severity:Severe FDA (Food)·F-0933-2022·Announced 2022-03-16

Abbott Similac Pro-Advance infant formula recalled for Cronobacter and Salmonella

Abbott is recalling Similac Pro-Advance infant formula due to potential contamination with Cronobacter sakazakii and Salmonella Newport. Consumer complaints related to these pathogens in infants have been reported, and the bacteria was found in the manufacturing facility.

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 requires a minimum severity score of 4 per the severity rubric. The recall involves contamination with Cronobacter sakazakii and Salmonella Newport in infant formula, with documented consumer complaints and evidence of manufacturing facility contamination.

Plain-English summary

Abbott Laboratories is recalling multiple sizes and formats of Similac Pro-Advance infant formula, including 20.6 oz., 30.3 oz., 34 oz., and 658g plastic jars, as well as 7 oz. cans. The recall affects 135,652 cases distributed in the United States and worldwide. Affected batch codes include 32624SH00, 34958SH00, 25673SH00, 31463SH00, 31549SH00, 32625SH00, 32626SH00, 25604K800, 31454K800, 35008K800, 37251K800, 35055SH00, 35056SH00, 32624SH01, 32625SH01, and 32626SH01.

The recall is due to potential contamination with Cronobacter sakazakii and Salmonella Newport. Consumer complaints related to these pathogens in infants have been reported, and evidence of Cronobacter sakazakii was found in the manufacturing facility where the product was produced.

Parents and caregivers who have purchased this formula should stop using it immediately and contact Abbott Laboratories or their healthcare provider. Infants who have consumed the formula and develop symptoms of illness should receive prompt medical attention.

The recalled product

Product: Abbott Similac Pro-Advance 20.6oz., 30.3oz., 34oz., and 658g plastic jar. 6 jars per case. 7oz. can. 6 cans per case. Item numbers: 6720113 6720813 6726613 6818013 6818213 6832313 Retail UPCs: 055325002499 055325002543 055325002604 055325002819 055325002833…
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: salmonella-newport
cronobacter-sakazakii
Affected units: 135,652

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 · salmonella newport