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Abbott Laboratories 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

United States

OngoingClass I

Company
Abbott Laboratories
Product
Abbott Similac Total Comfort 638g. plastic jar and 8oz. can.…
Recall date
February 17, 2022
Source
FDA

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

  1. - Recall initiated
  2. - Reported by source
Recalled products
Product description UPC Quantity Lot / code information
Abbott Similac Total Comfort 638g. plastic jar and 8oz. can. 6 units per case. Abbott Similac Advance Step-2 34oz. can. 6 cans per case. Item numbers: 6635013 6635113 6698413 Retail UPCs: 055325626602 055325626626 055325001652 Not published in this source record 109848 cases Batches: 23420SH00 32608SH00 26820K800 33725K800 37277K800 26821SH00 28089SH00 29245SH00 32607SH00 34861SH00 36124SH00

Distribution

  • US Nationwide. Worldwide.

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-0928-2022
Event ID
89629
Status
Ongoing
Classification
Class I
Company
Abbott Laboratories
Product description
Abbott Similac Total Comfort 638g. plastic jar and 8oz. can. 6 units per case. Abbott Similac Advance Step-2 34oz. can. 6 cans per case. Item numbers: 6635013 6635113 6698413 Retail UPCs: 055325626602 055325626626 055325001652
Quantity
109848 cases
Reason
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
Recall initiation date
February 17, 2022
Report date
March 16, 2022
Classification date
Not published in this source record
Termination date
Not terminated as of this source record
Distribution pattern
US Nationwide. Worldwide.
UPC, lot, and code information
Batches: 23420SH00 32608SH00 26820K800 33725K800 37277K800 26821SH00 28089SH00 29245SH00 32607SH00 34861SH00 36124SH00
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Press Release
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Other products recalled under this same event

This recall shares FDA event ID 89629 with 10 other product entries in Public Health Trace.

FDA Recall United States Ongoing Historical recordClass I

Abbott Laboratories

Product
Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can…
Published
March 16, 2022
Distribution
Nationwide

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FDA Recall United States Ongoing Historical recordClass I

Abbott Laboratories

Product
Abbott Infant Formula Powder 12.6oz. can. 6 cans per case.…
Published
March 16, 2022
Distribution
Nationwide

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FDA Recall United States Ongoing Historical recordClass I

Abbott Laboratories

Product
Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavor…
Published
March 16, 2022
Distribution
Nationwide

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FDA Recall United States Ongoing Historical recordClass I

Abbott Laboratories

Product
Abbott Similac Organic with A2 Milk Infant Formula with Iron…
Published
March 16, 2022
Distribution
Nationwide

View recall →

FDA Recall United States Ongoing Historical recordClass I

Abbott Laboratories

Product
Abbott Similac Pro-Advance Infant Formula with Iron 20.6oz.…
Published
March 16, 2022
Distribution
Nationwide

View recall →

FDA Recall United States Ongoing Historical recordClass I

Abbott Laboratories

Product
Abbott Similac Pro-Sensitive Infant Formula with Iron 20.1oz…
Published
March 16, 2022
Distribution
Nationwide

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FDA Recall United States Ongoing Historical recordClass I

Abbott Laboratories

Product
Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott E…
Published
March 16, 2022
Distribution
Nationwide

View recall →

FDA Recall United States Ongoing Historical recordClass I

Abbott Laboratories

Product
Abbott Similac Alimentum Infant Formula with Iron 12oz. can.…
Published
March 16, 2022
Distribution
Nationwide

View recall →

FDA Recall United States Ongoing Historical recordClass I

Abbott Laboratories

Product
Abbott Similac Sensitive Lactose Sensitivity 22oz. plastic j…
Published
March 16, 2022
Distribution
Nationwide

View recall →

FDA Recall United States Ongoing Historical recordClass I

Abbott Laboratories

Product
Abbott Similac Alimentum Toddler Drink 12.1oz. can. 6 cans…
Published
March 16, 2022
Distribution
Nationwide

View recall →

Responsible company: Abbott Laboratories

Other recalls from Abbott Laboratories

FDA Recall United States Terminated Historical recordClass II

Abbott Laboratories

Product
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in fo…
Published
November 15, 2023
Distribution
Alabama, Arkansas, Arizona, California,…

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FDA Recall United States Terminated Historical recordClass II

Abbott Laboratories

Product
Zone Perfect Fudge Graham bar 50g bars packaged in foil wrap…
Published
April 19, 2023
Distribution
Multiple states

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FDA Recall United States Terminated Historical recordClass II

Abbott Laboratories

Product
Similac Water - Sterilized (Export Canada) 2 fl oz reclose…
Published
November 23, 2022
Distribution
Domestic: Alaska, Alabama, Arizona, Cali…

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Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class I mean?

A situation in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.

Is this recall still active?

According to FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.