RecallHawk
Class I Recall

Abbott Similac For Spit Up Infant Formula with Iron 12.5oz. can. 6 cans per case. Item numbers: 5095976 Retail UP

Abbott Laboratories

Summary

The FDA issued a Class I for Abbott Similac For Spit Up Infant Formula with Iron 12.5oz. can. 6 cans per case by Abbott Laboratories. Reason: Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facil.

Details

Source

Food Recall

External ID

F-0940-2022

Action Date

2022-03-16

Status

Ongoing

Category

food

Product Description

Abbott Similac For Spit Up Infant Formula with Iron 12.5oz. can. 6 cans per case. Item numbers: 5095976 Retail UPCs: 070074509600

Lot/Code Info: Batches: 24447K807 24448K807 25674K800 25675K800 25677K800 25677K810 25798K800 26873K800 26874K800 26875K800 28024K800 28026K800 29247K800 29247K810 29248K800 29249K800 31502K800 31503K800 31504K800 33702K800 33703K800 33719K800 34854K800 34855K800 34856K800 34857K800 36100K800 36101K800 36102K800 36103K800

Quantity Affected: 409673 cases

Reason for Recall

Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced

Distribution

US Nationwide. Worldwide.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-02-17

Company

Abbott Laboratories

Abbott Park, IL

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 92 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Abbott Laboratories have FDA actions?

Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-0940-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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