Agency classClass IOur severity:Severe FDA (Food)·F-0935-2022·Announced 2022-03-16

Abbott Similac infant formula recalled due to bacterial contamination

Abbott is recalling multiple Similac infant formula products due to potential contamination with Cronobacter sakazakii and Salmonella Newport. These pathogens pose serious health risks to infants.

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 recall meets FDA Class I criteria, which requires a minimum severity score of 4. Consumer complaints related to Cronobacter sakazakii and Salmonella Newport in infants were reported; however, the source text does not explicitly state confirmed illnesses, hospitalizations, or deaths, which would be required for a Critical rating.

Plain-English summary

Abbott Laboratories is recalling Abbott Similac Advance Infant Formula with Iron and Abbott Similac Pro-Advance infant formula products. The recall includes multiple package sizes: 12.4 oz cans, 23.2 oz plastic jars, 20.6 oz plastic jars, and 34 oz plastic jars.

The recall was initiated due to evidence of Cronobacter sakazakii detected in the manufacturing facility where the products were produced. Additionally, consumer complaints related to Cronobacter sakazakii or Salmonella Newport have been received in connection with infants. Both pathogens pose serious health risks, particularly to vulnerable infant populations.

The recall affects infants who may have consumed or are currently consuming these formula products. Parents and caregivers should immediately consult with their healthcare provider if they have concerns about their infant's health or if their infant has consumed recalled formula.

The recall is nationwide and worldwide in distribution. Consumers with affected products should check the batch codes against the FDA recall notice to identify and safely discard or return recalled lots.

The recalled product

Product: Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Abbott Similac Pro-Advance 34oz. plastic jar. 6 jars per case. Item numbers: 53359 68084 5595776 6748701 Retail UPCs: 070074533605…
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 3,491,684

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