Abbott Laboratories
Complete recall history across all FDA and CPSC categories — 124 total recalls
Recall Summary
Abbott Laboratories appears in recall records across 3 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Food Recalls (61)
FDA food safety enforcement actions by Abbott Laboratories. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 31, 2023 | Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 fo... | Marketed towards preterm infants without approval as a new drug or licensed b... | Class II |
| Mar 28, 2023 | Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars indi... | Potential of foreign material (hard plastic) within product | Class II |
| Oct 13, 2022 | Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle Packag... | Compromised seal integrity which could lead to spoilage | Class II |
| Oct 13, 2022 | Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle ... | Compromised seal integrity which could lead to spoilage | Class II |
| Oct 13, 2022 | Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bottle 48 ... | Compromised seal integrity which could lead to spoilage | Class II |
| Oct 13, 2022 | Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plastic bott... | Compromised seal integrity which could lead to spoilage | Class II |
| Oct 13, 2022 | Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 coun... | Compromised seal integrity which could lead to spoilage | Class II |
| Oct 13, 2022 | Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plastic bott... | Compromised seal integrity which could lead to spoilage | Class II |
| Oct 13, 2022 | Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able plastic bo... | Compromised seal integrity which could lead to spoilage | Class II |
| Oct 13, 2022 | Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - ... | Compromised seal integrity which could lead to spoilage | Class II |
| Oct 13, 2022 | Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl o... | Compromised seal integrity which could lead to spoilage | Class II |
| Oct 13, 2022 | Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle Package... | Compromised seal integrity which could lead to spoilage | Class II |
| Oct 13, 2022 | Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 count case | Compromised seal integrity which could lead to spoilage | Class II |
| Oct 13, 2022 | Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 co... | Compromised seal integrity which could lead to spoilage | Class II |
| Jul 3, 2022 | Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral f... | Potential leaking/pinholes in bottle | Class II |
| Jun 3, 2022 | Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberry Lemona... | These products are being recalled due to the potential of leakage from the 1L... | Class II |
| Jun 3, 2022 | Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natu... | These products are being recalled due to the potential of leakage from the 1L... | Class II |
| Jun 3, 2022 | Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Le... | The third party contract manufacturer used a dextrose ingredient derived from... | Class III |
| Feb 17, 2022 | Abbott Similac Alimentum Infant Formula with Iron 12oz. can. 6 jars per case... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Similac Go... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Infant Formula Powder 12.6oz. can. 6 cans per case. Item numbers: ... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can. 6 cans per case... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Pro-Advance Infant Formula with Iron 20.6oz. and 23.2oz. plast... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Pro-Sensitive Infant Formula with Iron 20.1oz. and 22.5oz. pla... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Organic with A2 Milk Infant Formula with Iron 8oz. and 7oz. ca... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Alimentum Toddler Drink 12.1oz. can. 6 cans per case. Item... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavored 14.1oz. can. ... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Sensitive Lactose Sensitivity 22oz. plastic jar. 6 jars per c... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott EleCare, EleCare LCP Hypoallergenic, Similac EleCare 400g. can. 6 cans... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott EleCare Junior Vanilla 14.1oz. can and Abbott EleCare Jr Similac Vanil... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott EleCare Amino Acid-Based Powder Infant Formula with Iron 14.1oz. can, ... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO, Abbott... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Pro-Total Comfort Infant Formula with Iron 20.1oz. and 22.5oz.... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item n... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac For Spit Up Infant Formula with Iron 12.5oz. can. 6 cans per c... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. can. 6 ca... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30.3oz. pa... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate 14.1oz. can. 6... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 cans per... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Alimentum 400g. can. 6 cans per case. Item numbers: 5705... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Total Comfort 12.6oz. can. 6 cans per case. Item numbers: ... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Total Comfort 638g. plastic jar and 8oz. can. 6 units per cas... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Organic with A2 Milk Toddler Drink 23.2oz plastic jar. 4 jars ... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Advance Step-1 22oz. plastic jar and 34 oz. can. 6 units per ... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Formula 400g... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz. can. 6 ... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Pro-Advance 20.6oz., 30.3oz., 34oz., and 658g plastic jar. 6 j... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Advance Step-2 22.5oz. plastic jar. 6 jars per case. Abbott ... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Alimentum Eye Q Plus 400g. can. Abbott Alimentum Eye Q 400g. c... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
| Feb 17, 2022 | Abbott Similac Sensitive 34oz. plastic jar. 6 jars per case. Abbott Similac... | Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in... | Class I |
Drug Recalls (5)
FDA drug safety enforcement actions by Abbott Laboratories
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 4, 2012 | Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per b... | Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tabl... | Class II |
| Jul 19, 2012 | Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottl... | Defective Container: A number of Synthroid bottles have a localized thin wall... | Class II |
| Jul 19, 2012 | Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Count Bottl... | Defective Container: A number of Synthroid bottles have a localized thin wall... | Class II |
| Jul 19, 2012 | Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Count Bott... | Defective Container: A number of Synthroid bottles have a localized thin wall... | Class II |
| May 14, 2012 | Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial ... | CGMP Deviations: There is potential that Abbott's third party manufacturer, H... | Class II |
Device Recalls (58)
FDA medical device enforcement actions by Abbott Laboratories. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 13, 2025 | Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 | Abbott Laboratories is recalling their Alinity ci-series System Control Modul... | Class II |
| Sep 18, 2025 | Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Cat... | Software issue for hq analyzer results in system not visibly applying appropr... | Class II |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change... | Class II |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change... | Class II |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change... | Class II |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change... | Class II |
| Mar 18, 2025 | Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number:... | When expired reagents are scanned or manually entered, the system will change... | Class II |
| Jun 14, 2024 | Alinity hq Analyzer, REF: 09P68-01 | 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) ... | Class II |
| Feb 21, 2024 | ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20. | The reason for the recall is the failure of calibration and quality controls ... | Class II |
| Oct 19, 2023 | ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-... | The devices contain a dry natural rubber (latex) subcomponent, which are not ... | Class II |
| Oct 19, 2023 | Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DY... | The devices contain a dry natural rubber (latex) subcomponent, which are not ... | Class II |
| Oct 19, 2023 | Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module... | The devices contain a dry natural rubber (latex) subcomponent, which are not ... | Class II |
| Oct 19, 2023 | Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module... | The devices contain a dry natural rubber (latex) subcomponent, which are not ... | Class II |
| May 30, 2023 | Alinity ci-series System Control Module, REF: 03R70-01 | There are potential performance issues found in the Alinity ci-series System ... | Class II |
| Nov 24, 2022 | Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHI... | Reaction vessels may contain a potential contaminant that could affect their ... | Class III |
| Jul 26, 2022 | ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 | One lot of reagent was manufactured with insufficient quantities of the heter... | Class II |
| Jun 9, 2022 | REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2... | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c ... | Class II |
| Jun 9, 2022 | REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2... | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c ... | Class II |
| Jun 9, 2022 | REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2... | There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c ... | Class II |
| Mar 8, 2022 | ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myogl... | This calibrator lot did not meet acceptance criteria during ongoing stability... | Class II |
| Sep 29, 2021 | ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF ... | Twelve software-related issues affecting software version 9.41 and earlier we... | Class II |
| Sep 29, 2021 | ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/... | Twelve software-related issues affecting software version 9.41 and earlier we... | Class II |
| Jul 26, 2021 | Alinity ci-series System Control Module clinical chemistry and immunoassay an... | Due to potential performance issues with software version 3.2.3 and earlier. ... | Class II |
| Jun 10, 2021 | REF 8L92-22, Abbott Activated Alanine aminotransferase, for use with Architec... | There is a potential for >10% under-recovery on Activated Alanine Aminotransf... | Class II |
| Jun 10, 2021 | REF 8L92-21, Abbott Activated Alanine Aminotransferase, for use with Architec... | There is a potential for >10% under-recovery on Activated Alanine Aminotransf... | Class II |
| Jun 10, 2021 | REF: 08P1820, Abbott Alinity c Activated Alanine Aminotransferase reagent Ki... | There is a potential for 15% under-recovery on Activated Alanine Aminotransfe... | Class II |
| Jun 10, 2021 | REF 8L92-42, Abbott Activated Alanine Aminotransferase, for use with Architec... | There is a potential for >10% under-recovery on Activated Alanine Aminotransf... | Class II |
| Apr 2, 2020 | Accelerator APS Aliquoter Module, List number: 07L40 - Product Usage: The ACC... | In the case of an AQM clot detection error a portion of the distilled water f... | Class II |
| Apr 1, 2020 | ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnos... | Error in the renewal documentation process for license in Mexico. All in date... | Class III |
| Apr 1, 2020 | ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis ... | Error in the renewal documentation process for license in Mexico. All in date... | Class III |
| Apr 1, 2020 | ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnos... | Error in the renewal documentation process for license in Mexico. All in date... | Class III |
| May 24, 2019 | ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are for... | Presence of a time dependent, stability drift in patient and control results ... | Class III |
| May 24, 2019 | ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators ar... | Presence of a time dependent, stability drift in patient and control results ... | Class III |
| May 22, 2019 | "HEMOGLOBIN A1c CALIBRATORS *** REF 4P52-01 *** 307261/R03 *** S4P5X0 *** FOR... | Calibrator level 2 bottle may have been manufactured incorrectly for a portio... | Class II |
| May 9, 2019 | Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN Emerald i... | The diluent tubing used on the instrument appears cloudy or to have a powder/... | Class II |
| Apr 9, 2019 | ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calib... | Devices were delivered without the required dry ice. | Class III |
| Apr 9, 2019 | ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Cali... | Devices were delivered without the required dry ice. | Class III |
| Apr 9, 2019 | ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators ... | Devices were delivered without the required dry ice. | Class III |
| Apr 9, 2019 | Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assaye... | Devices were delivered without the required dry ice. | Class III |
| Apr 9, 2019 | ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHIT... | Devices were delivered without the required dry ice. | Class III |
| Apr 9, 2019 | Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assaye... | Devices were delivered without the required dry ice. | Class III |
| Apr 9, 2019 | ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibr... | Devices were delivered without the required dry ice. | Class III |
| Apr 9, 2019 | ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The AR... | Devices were delivered without the required dry ice. | Class III |
| Apr 9, 2019 | ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Ca... | Devices were delivered without the required dry ice. | Class III |
| Feb 20, 2019 | CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is an autom... | There is a potential for the device to generate Quality Control (QC) low or o... | Class II |
| Apr 18, 2017 | ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent micr... | Firm has identified that ARCHITECT SHBG results generated with the Potassium ... | Class II |
| Feb 13, 2017 | CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN R... | The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Rub... | Class II |
| Oct 11, 2016 | ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for t... | Abbott has identified negative interference from the drug N-Acetyl Cysteine (... | Class II |
| Mar 24, 2016 | CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematolo... | Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyze... | Class II |
| Mar 24, 2016 | The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic ... | Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to fal... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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