RecallHawk
Class I Recall

Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz. can. 6 cans per case. 20.1oz. and 29.5oz. plastic

Abbott Laboratories

Summary

The FDA issued a Class I for Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz. can. 6 can 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-0947-2022

Action Date

2022-03-16

Status

Ongoing

Category

food

Product Description

Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz. can. 6 cans per case. 20.1oz. and 29.5oz. plastic jar. 4 jars per case. Item numbers: 68070 68072 68118 Retail UPCs: 070074680712 070074680736 070074681191

Lot/Code Info: Batches: 30349SH00 30351SH00 30353SH00 32461SH00 36095SH00 34955SH00 34956SH00 34956SH01 34957SH00 36217SH00 32355K800 32464K800 35076K800 35077K800 36136K800 36137K800

Quantity Affected: 227970 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-0947-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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