Agency classClass IOur severity:Severe FDA (Food)·F-0929-2022·Announced 2022-03-16

Abbott Similac EleCare infant formula recalled for pathogen contamination

Abbott is recalling approximately 95,077 cases of Similac EleCare infant formula due to consumer complaints involving Cronobacter sakazakii and Salmonella Newport in infants, and detection of Cronobacter sakazakii 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 recall received an FDA Class I classification, which mandates a minimum severity of 4. The presence of high-risk pathogens Cronobacter sakazakii and Salmonella Newport with consumer complaints of illness in infants warrants a Severe classification.

Plain-English summary

Abbott Laboratories is recalling multiple Similac EleCare infant formula products distributed nationwide and worldwide. The recall involves approximately 95,077 cases of the product in 400-gram cans.

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

This recall affects parents and caregivers of infants using affected Similac EleCare products. Detailed product identification information, including item numbers, UPCs, and batch codes, is available through the FDA recall notice.

The recalled product

Product: Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, Abbott EleCare Similac 400g can. 6 cans per case Item numbers: 6676006 6676012 6676021 6676025 6676030 6676045 6676053 6676057 Retail UPCs: 8699548995217 0070074124155…
Manufacturer: Abbott Laboratories
Category: Food — Infant Formula
Hazard: cronobacter-sakazakii
salmonella-newport
Affected units: 95,077

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