The Recall Desk
Agency classClass IOur severity:CriticalFDA (Food)·F-0958-2022·Announced 2022-03-16

Abbott Similac PM Low Iron Infant Formula Recalled for Bacterial Contamination

Abbott Similac PM 60/40 Low Iron Infant Formula has been recalled due to contamination with Cronobacter sakazakii and Salmonella Newport. The recall affects 8,358 cases distributed nationally 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 is an FDA Class I recall, the highest FDA classification designated for products where there is reasonable probability of serious adverse health consequences or death. The recall involves high-risk bacterial pathogens (Cronobacter sakazakii and Salmonella Newport) with consumer complaints indicating adverse events in infants.

Plain-English summary

Abbott Similac PM 60/40 Low Iron Infant Formula in 14.1 oz cans is being recalled. The product was manufactured by Abbott Laboratories and distributed nationally and worldwide. The affected batch codes are 27032K80 (can) and 27032K800 (case), with a total of 8,358 cases involved.

The recall is due to consumer complaints related to Cronobacter sakazakii and Salmonella Newport detected in infants, and evidence of Cronobacter sakazakii found in the manufacturing facility where the product was produced.

This is an FDA Class I recall.

The recalled product

Product
Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can. 6 cans per case. Item numbers: 00850 Retail UPCs: 070074608501
Manufacturer
Abbott Laboratories
Category
Food — Infant Formula
Hazard
Affected units
8,358

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Batches: 27032K80 (can) / 27032K800 (case)

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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