Food recall: Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 070074104591

Class I FDA enforcement event 89629. Recall start date: 17 Feb 2022. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

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

Class I, in the words of FDA

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

Abbott Laboratories started this food recall on 17 Feb 2022. The firm address in the FDA record is in Abbott Park, IL. FDA put the recall in Class I. FDA event 89629 has 41 product records. The first FDA enforcement report date is 16 Mar 2022. The record gives the status Ongoing.

FDA enforcement report The 41 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

US Nationwide. Worldwide.

Recalling firm

Abbott Laboratories, Abbott Park, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

41 product records in the event.

FDA event 89629: product records
Recall number	Product	Quantity	Class	Status	Report date
F-0918-2022	Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 070074104591	6359 cases	Class I	Ongoing	16 Mar 2022
F-0919-2022	Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / Sachet per retail unit. 3 retail units per case Item numbers: 54598 5459813 5459814 5459820 5459886 6771009 Retail UPCs: 70074545998 070074545998 055325545996 070074109404 070074103297 070074671833	104146 cases	Class I	Ongoing	16 Mar 2022
F-0920-2022	Abbott Similac Alimentum Toddler Drink 12.1oz. can. 6 cans per case. Item numbers: 68398 Retail UPCs: 070074683997	5912 cases	Class I	Ongoing	16 Mar 2022
F-0921-2022	Abbott Similac Total Comfort 12.6oz. can. 6 cans per case. Item numbers: 6259962 Retail UPCs: 070074119953	13737 cases	Class I	Ongoing	16 Mar 2022
F-0922-2022	Abbott Similac for Supplementation 22oz. plastic jar. 4 jars per case. Item numbers: 63013 Retail UPCs: 070074629506 70074629506	22074 cases	Class I	Ongoing	16 Mar 2022
F-0923-2022	Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic jar. 6 jars per case. Item numbers: 5372976 Retail UPCs: 070074537306	21126 cases	Class I	Ongoing	16 Mar 2022
F-0924-2022	Abbott Similac Advance Step-1 22oz. plastic jar and 34 oz. can. 6 units per case. Item numbers: 6499213 6698213 Retail UPCs: 055325000808 055325001638	54507 cases	Class I	Ongoing	16 Mar 2022
F-0925-2022	Abbott Similac Advance Step-2 22.5oz. plastic jar. 6 jars per case. Abbott Similac Advance 34oz. can. 6 cans per case. Abbott Similac Pro-Advance 20.6oz. and 859g. plastic jar. 6 jars per case. Item numbers: 6499113 6698313 6818113 6818313 Retail UPCs: 055325000808 055325001645 055325002864 055325002888	103025 cases	Class I	Ongoing	16 Mar 2022
F-0926-2022	Abbott Similac Sensitive Lactose Sensitivity 22oz. plastic jar. 6 jars per case. Item numbers: 6499813 Retail UPCs: 055325001218	14207 cases	Class I	Ongoing	16 Mar 2022
F-0927-2022	Abbott Similac Alimentum Infant Formula with Iron 12oz. can. 6 jars per case; 19.8oz. can. 4 cans per case; 7oz. can. 6 cans per case Item numbers: 64715 64717 64719 Retail UPCs: 070074647128 070074647166 070074647180	1511774 cases	Class I	Ongoing	16 Mar 2022
F-0928-2022	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	109848 cases	Class I	Ongoing	16 Mar 2022
F-0929-2022	Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, Abbott EleCare Similac 400g can. 6 cans per case Item numbers: 6676006 6676012 6676021 6676025 6676030 6676045 6676053 6676057 Retail UPCs: 8699548995217 0070074124155 0070074123851 0070074120195 070074120850 070074122502 0070074120157	95077 cases	Class I	Ongoing	16 Mar 2022
F-0930-2022	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 070074680910	938215 cases	Class I	Ongoing	16 Mar 2022
F-0931-2022	Abbott Similac Pro-Advance Infant Formula with Iron 20.6oz. and 23.2oz. plastic jar. 4 jars per case; 34oz. plastic jar. 6 jars per case; 7oz. can. 6 cans per case. Item numbers: 66081 66655 67922 68088 Retail UPCs: 070074660806 070074666563 070074679167 070074680897	1728823 cases	Class I	Ongoing	16 Mar 2022
F-0932-2022	Abbott Similac Pro-Advance 23oz. and 34oz. plastic jar. 6 jars per case. Item numbers: 6720413 6721313 Retail UPCs: 055325002567 055325002581	26035 cases	Class I	Ongoing	16 Mar 2022
F-0933-2022	Abbott Similac Pro-Advance 20.6oz., 30.3oz., 34oz., and 658g plastic jar. 6 jars per case. 7oz. can. 6 cans per case. Item numbers: 6720113 6720813 6726613 6818013 6818213 6832313 Retail UPCs: 055325002499 055325002543 055325002604 055325002819 055325002833 055325003069	135652 cases	Class I	Ongoing	16 Mar 2022
F-0934-2022	Abbott Similac Pro-Total Comfort 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: 66798 66939 67925 68107 Retail UPCs: 070074667997 070074669403 070074679266 070074681085	766561 cases	Class I	Ongoing	16 Mar 2022
F-0935-2022	Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Abbott Similac Pro-Advance 34oz. plastic jar. 6 jars per case. Item numbers: 53359 68084 5595776 6748701 Retail UPCs: 070074533605 070074680859 070074559582 070074122373	3491684 cases	Class I	Ongoing	16 Mar 2022
F-0936-2022	Abbott Alimentum, Abbott Similac Alimentum, Abbott Similac Alimentum HMO, Abbott Alimentum Similac, Abbott Similac Gold Alimentum HMO 400g can. 6 cans per case. Item numbers: 674845 6748406 6748408 6748412 6748425 6748426 6748430 6748453 6748484 Retail UPCs: 0070074122250 8699548994869 070074122311 0070074124131…	209857 cases	Class I	Ongoing	16 Mar 2022
F-0937-2022	Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar. 6 jars per case. Item numbers: 5081776 Retail UPCs: 070074508184	46757 cases	Class I	Ongoing	16 Mar 2022
F-0938-2022	Abbott Similac Sensitive 34oz. plastic jar. 6 jars per case. Abbott Similac Sensitive Infant Formula with Iron 12.5oz. can and 20.1oz. plastic jar. 6 units per case. Item numbers: 68082 5753978 6748901 674891L Retail UPCs: 070074680835 070074575414 070074122380	2046814 cases	Class I	Ongoing	16 Mar 2022
F-0939-2022	Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per case. Item numbers: 62599 Retail UPCs: 070074626000	1226623 cases	Class I	Ongoing	16 Mar 2022
F-0940-2022	Abbott Similac For Spit Up Infant Formula with Iron 12.5oz. can. 6 cans per case. Item numbers: 5095976 Retail UPCs: 070074509600	409673 cases	Class I	Ongoing	16 Mar 2022
F-0941-2022	Abbott Similac For Spit Up Infant Formula with Iron 7oz. can and 19.5oz. plastic jar. 6 units per case. Item numbers: 67927 68086 Retail UPCs: 070074679280 070074680873	138075 cases	Class I	Ongoing	16 Mar 2022
F-0942-2022	Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum HMO, Abbott Similac Alimentum infant formula, Abbott Similac Alimentum 400g can. 6 cans per case. Item numbers: 6749111 6749117 6749118 6749124 6749134 6749166 6749181 6749199 Retail UPCs: 070074124476 070074124438 0070074124490…	34704 cases	Class I	Ongoing	16 Mar 2022
F-0943-2022	Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30.3oz. palstic jar. 4 jars per case. 7oz. can. 6 cans per case. Item numbers: 68063 68065 68109 Retail UPCs: 070074680644 070074680668 070074681108	342054 cases	Class I	Ongoing	16 Mar 2022
F-0944-2022	Abbott Similac Organic with A2 Milk Toddler Drink 23.2oz plastic jar. 4 jars per case. Abbott Similac Organic Toddler with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 jars per case. Item numbers: 67905 68104 Retail UPCs: 070074677576 070074681054	8514 cases	Class I	Ongoing	16 Mar 2022
F-0945-2022	Abbott Similac Organic 7oz. can. 6 cans per case. Abbott Similac Organic with A2 Milk Infant Formula with Iron 20.6oz. plastic jar. 4 jars per case. 23.2oz plastic jar. 6 jars per case. Item numbers: 68013 68092 5082178 Retail UPCs: 070074680156 070074680934 070074508221	52663 cases	Class I	Ongoing	16 Mar 2022
F-0946-2022	Abbott Similac Organic with A2 Milk Infant Formula with Iron 8oz. and 7oz. can. 6 cans per case. 20.6oz. plastic jar. 4 jars per case. Item numbers: 67904 68016 68099 Retail UPCs: 070074677545 070074680170 070074681009	54245 cases	Class I	Ongoing	16 Mar 2022
F-0947-2022	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	227970 cases	Class I	Ongoing	16 Mar 2022
F-0948-2022	Abbott EleCare, EleCare LCP Hypoallergenic, Similac EleCare 400g. can. 6 cans per case. Item numbers: 5351034 5351066 5351039 5351077 Retail UPCs: 17703186031461 9340104000706 17501033957748 070074119281	34585 cases	Class I	Ongoing	16 Mar 2022
F-0949-2022	Abbott EleCare Amino Acid-Based Powder Infant Formula with Iron 14.1oz. can, Abbott Elecare 400g. can, Abbott Elecare Unflavored 14.1oz. can. 6 cans per case. Item numbers: 55251 5525157 5525189 Retail UPCs: 070074535111 070074116297 070074119854	425750 cases	Class I	Ongoing	16 Mar 2022
F-0950-2022	Abbott EleCare Junior Vanilla 14.1oz. can and Abbott EleCare Jr Similac Vanilla 14.1oz. can. 6 cans per case. Item numbers: 56585 5658557 Retail UPCs: 070074565866 070074116723	116350 cases	Class I	Ongoing	16 Mar 2022
F-0951-2022	Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavored 14.1oz. can. 6 cans per case. Item numbers: 55253 Retail UPCs: 070074552545 70074552545	203416 cases	Class I	Ongoing	16 Mar 2022
F-0952-2022	Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. can. 6 cans per case. Item numbers: 66275 Retail UPCs: 070074662763	14536 cases	Class I	Ongoing	16 Mar 2022
F-0953-2022	Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate 14.1oz. can. 6 cans per case. Item numbers: 66273 Retail UPCs: 070074662718	12684 cases	Class I	Ongoing	16 Mar 2022
F-0954-2022	Abbott Similac Alimentum 400g. can. 6 cans per case. Item numbers: 5705806 Retail UPCs: 8699548994869	35965 cases	Class I	Ongoing	16 Mar 2022
F-0955-2022	Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g. can. 6 cans per case. Item numbers: 5707713 Retail UPCs: 055325000624	45223 cases	Class I	Ongoing	16 Mar 2022
F-0956-2022	Abbott Similac Alimentum Eye Q Plus 400g. can. Abbott Alimentum Eye Q 400g. can. Abbott Alimentum Eye Q Hypoallergenic 400g. can. 6 cans per case. Item numbers: 6208407 6208418 6208481 6208482 6208483 Retail UPCs: 070074110431 070074123905 070074110356 070074111834 070074110271	40943 cases	Class I	Ongoing	16 Mar 2022
F-0957-2022	Abbott Infant Formula Powder 12.6oz. can. 6 cans per case. Item numbers: Clinical Retail UPCs: N/A - Clinical	500 cases	Class I	Ongoing	16 Mar 2022
F-0958-2022	Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can. 6 cans per case. Item numbers: 00850 Retail UPCs: 070074608501	8,358 cases	Class I	Ongoing	16 Mar 2022

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class I: The highest of the three FDA recall classes.

The event in context

Food events that started in 2022: 452
Share of these events in Class I: 38%
Product records in this event: 41Median of the firm: 1
Events of the firm on the register: 46

Other events of the firm

Other FDA enforcement events of Abbott Laboratories
Initiated	Product (first record)	Type	Class	Records
13 Nov 2025	Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20	Device	Class II	1
18 Sep 2025	Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 t	Device	Class II	1
18 Mar 2025	Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software vers	Device	Class II	5
14 Jun 2024	Alinity hq Analyzer, REF: 09P68-01	Device	Class II	1
21 Feb 2024	ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.	Device	Class II	1
31 Oct 2023	Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.	Food	Class II	1
19 Oct 2023	Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number	Device	Class II	1
19 Oct 2023	Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allow	Device	Class II	3
30 May 2023	Alinity ci-series System Control Module, REF: 03R70-01	Device	Class II	1
28 Mar 2023	Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton	Food	Class II	1

Abbott Laboratories: all 46 events

Official channels

FDA enforcement report F-0918-2022The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA: report a problemThe FDA page that shows where a report about a product goes.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 89629. https://recallregister.com/fda/i/89629/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA food enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: US Nationwide. Worldwide.
What quantity of product is in FDA event 89629?: The event has 41 product records. The first record gives this quantity: 6359 cases
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many food recalls of 2022 have the same class?: 38% of the 452 food events that started in 2022 are in Class I.