Agency classClass IOur severity:Severe FDA (Food)·F-0919-2022·Announced 2022-03-16

Abbott Similac Human Milk Fortifier Recalled Due to Pathogen Risk

Abbott Similac Human Milk Fortifier pouches are recalled due to potential Cronobacter sakazakii and Salmonella Newport contamination. The recall affects infants who may have received contaminated product.

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: FDA Class I classification requires a minimum severity of Severe per the rubric. Cronobacter sakazakii and Salmonella Newport are high-risk pathogens capable of serious illness in infants, and consumer complaints related to these organisms have been reported.

Plain-English summary

Abbott Laboratories is recalling Abbott Similac Human Milk Fortifier 0.9g pouches distributed nationwide and worldwide. The recall covers 104,146 cases across multiple batch codes.

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

The product is used by infants, particularly premature and ill infants in neonatal care settings, as a nutritional supplement to breast milk.

Consumers should stop using the affected product immediately and consult with their healthcare provider. The specific affected batches and UPCs are listed in the product information.

The recalled product

Product: Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case Item numbers: 54598 5459813 5459814 5459820 5459886 6771009 Retail UPCs: 70074545998 070074545998 055325545996 070074109404 070074103297…
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula Supplement
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 104,146

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