Agency classClass IOur severity:Severe FDA (Food)·F-0942-2022·Announced 2022-03-16

Abbott Similac Alimentum infant formula recalled for Cronobacter and Salmonella

Abbott Laboratories is recalling Similac Alimentum infant formula due to contamination with Cronobacter sakazakii and Salmonella Newport. The recall involves 34,704 cases distributed nationwide and worldwide following consumer complaints and manufacturing facility testing.

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 for infant formula contaminated with high-risk pathogens (Cronobacter sakazakii and Salmonella Newport) with documented consumer complaints indicating actual incidents in a vulnerable population. No deaths reported.

Plain-English summary

Abbott Laboratories is recalling multiple lots of Abbott Similac Alimentum infant formula, including products labeled as Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum HMO, and Abbott Similac Alimentum in 400g cans. The recall involves 34,704 cases with specific lot codes and retail UPCs identified by the FDA.

The recall was initiated following consumer complaints related to Cronobacter sakazakii and Salmonella Newport in infants, and following detection of Cronobacter sakazakii in the Abbott manufacturing facility where the product was produced.

The affected product was distributed nationwide in the United States and worldwide. Consumers who have purchased this product should stop using it immediately and consult their healthcare provider if they have concerns about their infant's health in relation to this recall or if they believe their child may have been exposed.

The recalled product

Product: Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum HMO, Abbott Similac Alimentum infant formula, Abbott Similac Alimentum 400g can. 6 cans per case. Item numbers: 6749111 6749117 6749118 6749124 6749134 6749166 6749181 6749199…
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
bacterial-contamination
Affected units: 34,704

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