The Recall Desk
Agency classClass IOur severity:CriticalFDA (Food)·F-0930-2022·Announced 2022-03-16

Abbott Similac Pro-Sensitive Infant Formula Recalled for Cronobacter and Salmonella

Abbott Similac Pro-Sensitive Infant Formula is being recalled due to consumer complaints of Cronobacter sakazakii and Salmonella Newport in infants, with evidence of Cronobacter found 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 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: FDA Class I recall with documented consumer complaints of Cronobacter sakazakii and Salmonella Newport infections in infants and evidence of pathogen contamination in the manufacturing facility.

Plain-English summary

Abbott Laboratories is recalling Abbott Similac Pro-Sensitive Infant Formula with Iron in multiple sizes: 20.1 oz and 22.5 oz plastic jars, 34 oz plastic jars, and 7 oz cans. The recall affects approximately 938,215 cases distributed nationwide and worldwide.

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

Consumers who have this product should stop using it. Consumers should consult their healthcare provider if they have concerns about their infant's health related to consumption of this product.

The recalled product

Product
Abbott Similac Pro-Sensitive Infant Formula with Iron 20.1oz. and 22.5oz. plastic jar. 4 jars per case; 34oz. plastic jar. 6 jars per case; 7oz. can. 6 cans per case. Item numbers: 66084 66657 67923 68090 Retail UPCs: 070074660820 070074666587 070074679242…
Affected units
938,215

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 →

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