PlainRecalls

Abbott Laboratories

Compiled from official public sources by the editorial team.

124 recalls on record · Latest: Dec 24, 2025

Abbott Laboratories Recall Insight

Abbott Laboratories appears on 124 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.122% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 24, 2025, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 29 critical, 11 moderate, and 10 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 4 distinct product categories, with issuing agencies dominated by FDA Food (30), FDA Devices (20). The date window on this page runs from May 22, 2019 to Mar 16, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Food Critical Mar 16, 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 672…

FDA Food Critical Mar 16, 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…

FDA Food Critical Mar 16, 2022

Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g. can. 6 cans per case. Item numbers: 5707713 Retail UPCs: 05…

FDA Food Critical Mar 16, 2022

Abbott Similac Advance Step-1 22oz. plastic jar and 34 oz. can. 6 units per case. Item numbers: 6499213 6698213 Retail UPCs: 055325000808 …

FDA Food Critical Mar 16, 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 wi…

FDA Food Critical Mar 16, 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 nu…

FDA Food Critical Mar 16, 2022

Abbott Similac Total Comfort 12.6oz. can. 6 cans per case. Item numbers: 6259962 Retail UPCs: 070074119953

FDA Food Critical Mar 16, 2022

Abbott Similac Alimentum 400g. can. 6 cans per case. Item numbers: 5705806 Retail UPCs: 8699548994869

FDA Food Critical Mar 16, 2022

Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per case. Item numbers: 62599 Retail UPCs: 070074626000

FDA Food Critical Mar 16, 2022

Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate 14.1oz. can. 6 cans per case. Item numbers: 66273 Retail UPCs: 070074662718

FDA Food Critical Mar 16, 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:…

FDA Food Critical Mar 16, 2022

Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. can. 6 cans per case. Item numbers: 66275 Retail UPCs: 070074662763

FDA Food Critical Mar 16, 2022

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

FDA Food Critical Mar 16, 2022

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

FDA Food Critical Mar 16, 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. …

FDA Food Critical Mar 16, 2022

Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott Alimentum HMO, Abbott Similac Alimentum infant formula, Abbott Similac …

FDA Food Critical Mar 16, 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…

FDA Food Critical Mar 16, 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 R…

FDA Food Critical Mar 16, 2022

Abbott EleCare, EleCare LCP Hypoallergenic, Similac EleCare 400g. can. 6 cans per case. Item numbers: 5351034 5351066 5351039 5351077 Reta…

FDA Food Critical Mar 16, 2022

Abbott Similac Sensitive Lactose Sensitivity 22oz. plastic jar. 6 jars per case. Item numbers: 6499813 Retail UPCs: 055325001218

FDA Food Critical Mar 16, 2022

Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavored 14.1oz. can. 6 cans per case. Item numbers: 55253 Retail UPCs: 070074552545…

FDA Food Critical Mar 16, 2022

Abbott Similac Alimentum Toddler Drink 12.1oz. can. 6 cans per case. Item numbers: 68398 Retail UPCs: 070074683997

FDA Food Critical Mar 16, 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 numb…

FDA Food Critical Mar 16, 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.…

FDA Food Critical Mar 16, 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…

FDA Food Critical Mar 16, 2022

Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can. 6 cans per case. Item numbers: 00850 Retail UPCs: 070074608501

FDA Food Critical Mar 16, 2022

Abbott Infant Formula Powder 12.6oz. can. 6 cans per case. Item numbers: Clinical Retail UPCs: N/A - Clinical

FDA Food Critical Mar 16, 2022

Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Gold, Abbott EleCare Similac 400g can. 6 cans per case Item numbers: …

FDA Food Critical Mar 16, 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 numbe…

FDA Devices Moderate Dec 1, 2021

ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89

FDA Devices Moderate Dec 1, 2021

ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;

FDA Devices Moderate Sep 22, 2021

Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01

FDA Devices Moderate Aug 11, 2021

REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161866

FDA Devices Moderate Aug 11, 2021

REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Kit, Alinity c Activated Alanine Aminotransferase Reagent Kit,, IVD, CE, U…

FDA Devices Moderate Aug 11, 2021

REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740017866

FDA Devices Moderate Aug 11, 2021

REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architect, IVD, CE, UDI: (01) 00380740161859

FDA Devices Moderate Jun 10, 2020

Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACCELERATOR APS Workcell is a modular system designed to automate sample ha…

FDA Devices Low May 13, 2020

ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including d…

FDA Devices Low May 13, 2020

ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diab…

FDA Devices Low May 13, 2020

ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including d…

FDA Devices Moderate Apr 15, 2020

"HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR USE WITH ARCHITECT" - Product Usage: use in the calibration of the Hemo…

FDA Devices Moderate Oct 30, 2019

Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald instrument, List number 09H39-01. The firm name on the label is Abbott L…

FDA Food Moderate Oct 16, 2019

Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iron, powder in a 13.2 oz. can, with 6 cans per case.

FDA Devices Low Jul 31, 2019

ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantit…

FDA Devices Low Jul 31, 2019

ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for the estimation of test precision and the detection of systematic analy…

FDA Devices Low May 22, 2019

ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for…

FDA Devices Low May 22, 2019

ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation o…

FDA Devices Low May 22, 2019

ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for th…

FDA Devices Low May 22, 2019

Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor th…

FDA Devices Low May 22, 2019

ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of te…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.