Agency classClass IOur severity:Critical FDA (Food)·F-0932-2022·Announced 2022-03-16

Abbott Similac Pro-Advance Infant Formula Recalled for Bacterial Contamination

Abbott Similac Pro-Advance infant formula is being recalled due to potential contamination with Cronobacter sakazakii and Salmonella Newport. The FDA Class I recall affects products distributed nationwide and worldwide.

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, the most serious category for food recalls, indicating serious potential for adverse health effects. The pathogens involved—Cronobacter sakazakii and Salmonella Newport—pose particular risk to vulnerable infants.

Plain-English summary

Abbott Laboratories has recalled Abbott Similac Pro-Advance infant formula distributed nationwide and worldwide. The recall involves 23-ounce and 34-ounce plastic jars, multiple batch codes, and approximately 26,035 cases.

The FDA issued a Class I recall following consumer complaints related to Cronobacter sakazakii and Salmonella Newport in infants. Cronobacter sakazakii has also been detected in the manufacturing facility where the product was produced.

Affected lot codes are listed on the FDA recall notice. Parents and caregivers should discontinue use of these products immediately. If an infant has consumed this formula, consult a healthcare provider, especially if symptoms of illness develop.

The recalled product

Product: Abbott Similac Pro-Advance 23oz. and 34oz. plastic jar. 6 jars per case. Item numbers: 6720413 6721313 Retail UPCs: 055325002567 055325002581
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 26,035

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